<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04433052</url>
  </required_header>
  <id_info>
    <org_study_id>CPP-2020-1</org_study_id>
    <nct_id>NCT04433052</nct_id>
  </id_info>
  <brief_title>Clinical Value and Cost-effectiveness of a Personalized Prevention Program (PPP) in Patients With High Risk Stable CHD</brief_title>
  <official_title>A Prospective Clinical Trial to Evaluate the Clinical Value and Cost-effectiveness of a Personalized Prevention Program in Patients With High Risk Stable Coronary Heart Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Tampere University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Tampere University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Prospective clinical study with two parts:&#xD;
&#xD;
      PART A: a prospective biomarker-based risk screening study in coronary heart disease (CHD)&#xD;
      subjects PART B: a nested randomized clinical trial (RCT) in an enriched subpopulation of&#xD;
      high-risk stable CHD subjects&#xD;
&#xD;
      PART A: 12 000 subjects with stable CHD&#xD;
&#xD;
      PART B: 2000 subjects with high risk of CV events will be randomized to usual care (UC) or&#xD;
      personalised prevention program (PPP) i.e. 1000 subjects per arm.&#xD;
&#xD;
      Study purpose is to assess the clinical value and cost-effectiveness of a personalised&#xD;
      prevention program (PPP) in high-risk, stable coronary heart disease (CHD) subjects and to&#xD;
      prospectively validate risk screening biomarkers&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Primary Objectives:&#xD;
&#xD;
      PART A:&#xD;
&#xD;
        -  To prospectively validate biomarkers in risk stratification among stable CHD subjects,&#xD;
           i.e. evaluation of the biomarker performance in accurately predicting CV events&#xD;
           including CV death, nonfatal MI, HF events&#xD;
&#xD;
        -  To identify high-risk CHD subjects for the subsequent RCT, i.e. 15-20% of the screened&#xD;
           patient population at the highest risk&#xD;
&#xD;
      PART B&#xD;
&#xD;
      • To demonstrate whether a personalised prevention (PPP) strategy in high-risk CHD subjects&#xD;
      results in a decreased risk of cardiovascular (CV) events (CV death, nonfatal myocardial&#xD;
      infarction (MI) or heart failure (HF) events) as compared to the local usual care (UC)&#xD;
&#xD;
      Secondary Objectives:&#xD;
&#xD;
        -  To evaluate the difference between the PPP arm to the UC arm as listed in section&#xD;
           outcomes.&#xD;
&#xD;
        -  To evaluate the health economic value of the PPP&#xD;
&#xD;
        -  To prospectively study associations (in all enrolled subjects) between separate&#xD;
           biomarkers (CERT2, hs-troponin, proBNP, Cystatin C) or their score (CoroPredict)&#xD;
&#xD;
      In addition to the above-listed primary and secondary objectives of the study, the following&#xD;
      analysis will be carried out based on the data to be collected during the trial:&#xD;
&#xD;
        -  Effect of personalised prevention on behavioural change.&#xD;
&#xD;
        -  Effect of behavioural change on CV outcomes and blood pressure.&#xD;
&#xD;
        -  Identification of key components and risk factors affecting effectiveness of the PPP.&#xD;
&#xD;
        -  Inter-relationship between nutrition and exercise will be evaluated. Nutrition&#xD;
           parameters will be based on questionnaires and biomarkers (Trimethylamine N-oxide&#xD;
           (TMAO), Trimethyllysine (TML), carnitines and their metabolites).&#xD;
&#xD;
        -  Effect of the use of the CoroPrevention Tool Suite (EXPERT tool) on the agreement&#xD;
           between exercise prescriptions generated by cardiovascular nurses to subjects with CVD,&#xD;
           and the ESC guideline-directed exercise prescriptions&#xD;
&#xD;
        -  Effect of greater adherence to EXPERT tool-driven exercise prescriptions by clinicians&#xD;
           and subjects, on CVD risk, physical fitness, and prognosis (hospitalisations, adverse&#xD;
           events, mortality) in subjects with CVD.&#xD;
&#xD;
        -  Effect of the use of the EXPERT tool-driven medication decision support system on the&#xD;
           agreement between medication prescriptions generated by cardiovascular nurses to&#xD;
           subjects with CVD, and the ESC guideline-directed medication prescriptions&#xD;
&#xD;
        -  Effect of better adherence by both clinicians and subjects to ESC guideline&#xD;
           prescriptions, driven by the medication decision support system within the EXPERT tool,&#xD;
           on CVD risk and prognosis (hospitalisations, adverse events, mortality) in subjects with&#xD;
           CVD.&#xD;
&#xD;
        -  Investigation of the user experience and user acceptance of the CoroPrevention Tool&#xD;
           Suite.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">February 1, 2023</start_date>
  <completion_date type="Anticipated">December 2026</completion_date>
  <primary_completion_date type="Anticipated">December 2026</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>To demonstrate whether a PPP strategy in high-risk CHD subjects results in a decreased risk of CV events (CV death, nonfatal MI or HF events) compared to the UC</measure>
    <time_frame>3 years follow-up</time_frame>
    <description>• The time from randomisation to the occurrence of the first CV event included in the composite endpoint of the study (CV death, nonfatal MI, HF events) over 3 years follow-up.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>To evaluate the difference between PPP arm to the UC arm in</measure>
    <time_frame>3 years follow-up</time_frame>
    <description>o The times from randomisation to the occurrence of the specific items included in the composite endpoint (CV death, nonfatal MI, HF event) over 3 years follow-up</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To evaluate the difference between PPP arm to the UC arm in</measure>
    <time_frame>3 years follow-up</time_frame>
    <description>o The times from randomisation to the occurrence of secondary CV events (unstable angina, stroke and coronary revascularisations excluding those elective revascularisations that have been planned prior to randomisation)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To evaluate the difference between PPP arm to the UC arm in</measure>
    <time_frame>3 years follow-up</time_frame>
    <description>o Treatment adherence; measured by compliance laboratory assessments and in the PPP group, also with activity reports</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To evaluate the difference between PPP arm to the UC arm in</measure>
    <time_frame>3 years follow-up</time_frame>
    <description>All-cause mortality</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To evaluate the difference between PPP arm to the UC arm in</measure>
    <time_frame>3 years follow-up</time_frame>
    <description>Incidence of additional clinical endpoints: diabetes mellitus type 2 (DM2), chronic kidney disease (CKD), peripheral artery disease (PAD) and hypertension</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To evaluate the health economic value of the PPP</measure>
    <time_frame>3 years follow-up</time_frame>
    <description>o A cost-effectiveness analysis of PPP versus UC will be undertaken, based on evidence from the randomised clinical trial (RCT) portion of the study, using within-trial analysis and long-term cost-effectiveness modelling for the six countries participating in the CoroPrevention trial: Finland, Poland, Greece, Portugal, Italy, and Germany.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>• To prospectively study associations (in all enrolled subjects) between separate risk biomarkers (CERT2, hs-troponin , proBNP, Cystatin C) or their score (CoroPredict) and</measure>
    <time_frame>3 years follow-up</time_frame>
    <description>Primary composite CV event (CV death, MI, HF events)&#xD;
Specific CV events (CV death, nonfatal MI, HF events) separately&#xD;
Specific secondary CV events (unstable angina, stroke, coronary revascularisations)&#xD;
Incidence of DM2, CKD, PAD and hypertension</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">12000</enrollment>
  <condition>Coronary Heart Disease</condition>
  <arm_group>
    <arm_group_label>Personalised prevention program (PPP)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will be invited to return to the study site six times over a three year period to receive lifestyle coaching and exercise prescriptions. Eupropean Society of Cardiology/European Association of Preventive Cardiology (ESC/EAPC) -designed lifestyle counselling will be partially delivered by novel smartphone applications. Participants will also receive pharmaceutical treatment according to the ESC guideline for chronic coronary syndromes.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Usual care (UC)</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Participants will be referred back to usual care provided by their treating physicians. It is anticipated that physicians will treat these participants according to local usual medical practices. Patients randomized to UC group will not receive any treatment recommendations nor restrictions by the study investigators or nurses.&#xD;
Randomized UC patients are invited to site visits twice over a three year period.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>personalised prevention program (PPP)</intervention_name>
    <description>Study subjects in the PPP arm will be invited to return to the study site six times over a three-year period (at V2/start of the study, V3/mo2, V4/mo6, V5/mo12, V6/mo18 and V7/mo36) to receive lifestyle coaching and exercise prescriptions led by a delegated member of the site staff and supervised by the investigator. Information on drug treatment will also be given by the investigator. These activities will be assisted by digital tools specifically designed for this study, the CoroPrevention Tool Suite.</description>
    <arm_group_label>Personalised prevention program (PPP)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Eligible study subjects must meet all of the following inclusion criteria:&#xD;
&#xD;
          1. Informed consent form signed by the study subjects.&#xD;
&#xD;
          2. Male or female aged 30 to 80 years on the day of enrolment.&#xD;
&#xD;
          3. &gt; 50% stenosis in one or more major coronary arteries on angiography or computerised&#xD;
             tomography (CT) performed within the preceding one year (from enrolment visit).&#xD;
&#xD;
        or Myocardial infarction (type I, II) during the preceding year.&#xD;
&#xD;
        Eligible study subjects must not meet any of the following exclusion criteria:&#xD;
&#xD;
          1. Hospitalisation for acute coronary syndrome, myocardial infarction, stroke, coronary&#xD;
             revascularisation or acute heart failure within the preceding one month (30 days).&#xD;
             These subjects can be enrolled after a one-month stabilisation period, which begins&#xD;
             from the time of the event.&#xD;
&#xD;
          2. Subjects with NYHA class III-IV heart failure i.e. marked limitation in activity due&#xD;
             to symptoms, comfortable only at rest.&#xD;
&#xD;
          3. Uncontrolled arrhythmias such as ventricular tachycardias.&#xD;
&#xD;
          4. Subjects undergoing dialysis due to severe renal disease.&#xD;
&#xD;
          5. Diseases that severely disable exercising (per investigator's judgement), such as&#xD;
             rheumatoid arthritis, neurological or orthopaedic diseases.&#xD;
&#xD;
          6. Known aplastic or haemolytic anaemia.&#xD;
&#xD;
          7. Concomitant non-coronary disease, such as malignancy that limits life expectancy to&#xD;
             less than three years.&#xD;
&#xD;
          8. Concurrent participation in another interventional study.&#xD;
&#xD;
          9. Subjects not able and/or willing to attend all scheduled visits and comply with all&#xD;
             study procedures and use a smartphone application.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Reijo Laaksonen, MD, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Tampere University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Hanna Marttila, MSc</last_name>
    <phone>+358407240771</phone>
    <email>hanna.marttila@tuni.fi</email>
  </overall_contact>
  <location>
    <facility>
      <name>Helsinki University Hospital</name>
      <address>
        <city>Helsinki</city>
        <country>Finland</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Juha Sinisalo, MD, PhD</last_name>
      <email>juha.sinisalo@hus.fi</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Mehiläinen</name>
      <address>
        <city>Helsinki</city>
        <country>Finland</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Kristiina Hotakainen, MD, PhD</last_name>
      <email>Kristina.Hotakainen@mehilainen.fi</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Kuopio University Hospital</name>
      <address>
        <city>Kuopio</city>
        <country>Finland</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Juha Hartikainen, MD, PhD</last_name>
      <email>juha.hartikainen@kuh.fi</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Oulu University Hospital</name>
      <address>
        <city>Oulu</city>
        <country>Finland</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Janne Hukkanen, MD, PhD</last_name>
      <email>janne.hukkanen@ppshp.fi</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Klinik am See</name>
      <address>
        <city>Berlin</city>
        <country>Germany</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Heinz Völler, MD, PhD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>CCV-MVZ</name>
      <address>
        <city>Frankfurt</city>
        <country>Germany</country>
      </address>
    </facility>
    <status>Withdrawn</status>
  </location>
  <location>
    <facility>
      <name>Heidelberg University</name>
      <address>
        <city>Mannheim</city>
        <country>Germany</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Winfried März, MD, PhD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Technise Universität Munchen</name>
      <address>
        <city>München</city>
        <country>Germany</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Martin Halle, MD, PhD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Herzklinik Ulm</name>
      <address>
        <city>Ulm</city>
        <country>Germany</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Ralf Birkemeyer, MD, PhD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hellenic Red Cross Hospital</name>
      <address>
        <city>Athens</city>
        <country>Greece</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Nikolaos Bourmpoulis, MD, PhD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Konstantopoulio Hospital</name>
      <address>
        <city>Athens</city>
        <country>Greece</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Patsilinakos Sotirios, MD, PhD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Sismanoglion Hospital</name>
      <address>
        <city>Athens</city>
        <country>Greece</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Dimitrios Sionis, MD, PhD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>The Biomedical Research Foundation of the Academy Athens</name>
      <address>
        <city>Athens</city>
        <country>Greece</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Constantinos Davos, MD, PhD</last_name>
      <email>cdavos@bioacademy.gr</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>University Hospital Genova</name>
      <address>
        <city>Genova</city>
        <country>Italy</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Itolo Porto, MD, PhD</last_name>
      <email>italo.porto@unige.it</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Multi Medica, Care and Research Institute</name>
      <address>
        <city>Milan</city>
        <country>Italy</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Roberto FE Pedretti, MD, PhD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Casilino Hospital Rome</name>
      <address>
        <city>Rome</city>
        <country>Italy</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Leonardo Calo, MD, PhD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>University Hospital Turin</name>
      <address>
        <city>Turin</city>
        <country>Italy</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Gaetano de Ferrari, MD, PhD</last_name>
      <email>gaetanomaria.deferrari@unito.it</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>University of Bialystok</name>
      <address>
        <city>Białystok</city>
        <country>Poland</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Karol Kaminski, MD, PhD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Medical University of Silesia</name>
      <address>
        <city>Katowice</city>
        <country>Poland</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Zbigniew Gasior, MD, PhD</last_name>
      <email>zgasior@ptkardio.pl</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Jagellonian University Medical College</name>
      <address>
        <city>Kraków</city>
        <country>Poland</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Piotor Jankowski, MD, PhD</last_name>
      <email>piotrjankowski@interia.pl</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>University of Lublin</name>
      <address>
        <city>Lublin</city>
        <country>Poland</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Andrzej Wysokinski, MD, PhD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Nicolaus Copernicus University</name>
      <address>
        <city>Toruniak</city>
        <country>Poland</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Aldona Kubica, MD, PhD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>National Institute of Cardiology</name>
      <address>
        <city>Warsaw</city>
        <country>Poland</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Rafal Dabrowski, MD, PhD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hospital de Santa Cruz-CHLO</name>
      <address>
        <city>Carnaxide</city>
        <country>Portugal</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Miguel Mendes, MD, PhD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hospital do Espirito Santo</name>
      <address>
        <city>Lisbon</city>
        <country>Portugal</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Lino Patricio, MD, PhD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hospital Santa Maria-CHULN/FMUL</name>
      <address>
        <city>Lisbon</city>
        <country>Portugal</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Ana Abreu, MD, PhD</last_name>
      <email>ananabreu@hotmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Finland</country>
    <country>Germany</country>
    <country>Greece</country>
    <country>Italy</country>
    <country>Poland</country>
    <country>Portugal</country>
  </location_countries>
  <verification_date>June 2023</verification_date>
  <study_first_submitted>June 4, 2020</study_first_submitted>
  <study_first_submitted_qc>June 11, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 16, 2020</study_first_posted>
  <last_update_submitted>June 9, 2023</last_update_submitted>
  <last_update_submitted_qc>June 9, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">June 12, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Tampere University</investigator_affiliation>
    <investigator_full_name>Reijo Laaksonen</investigator_full_name>
    <investigator_title>Project Director</investigator_title>
  </responsible_party>
  <keyword>Prevention</keyword>
  <keyword>Coronary Heart Disease</keyword>
  <keyword>Biomarkers</keyword>
  <keyword>Lifestyle</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Heart Diseases</mesh_term>
    <mesh_term>Coronary Disease</mesh_term>
    <mesh_term>Coronary Artery Disease</mesh_term>
    <mesh_term>Myocardial Ischemia</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>EU open access policy</ipd_description>
    <ipd_time_frame>opens 2 years after last study patient visit, open for 18 years until IPD deletion</ipd_time_frame>
    <ipd_access_criteria>Steering Committee decision, application needed</ipd_access_criteria>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04433052
org study id: CPP-2020-1
nct id: NCT04433052
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
is us export: No
Prospective clinical study with two parts:

      PART A: a prospective biomarker-based risk screening study in coronary heart disease (CHD)
      subjects PART B: a nested randomized clinical trial (RCT) in an enriched subpopulation of
      high-risk stable CHD subjects

      PART A: 12 000 subjects with stable CHD

      PART B: 2000 subjects with high risk of CV events will be randomized to usual care (UC) or
      personalised prevention program (PPP) i.e. 1000 subjects per arm.

      Study purpose is to assess the clinical value and cost-effectiveness of a personalised
      prevention program (PPP) in high-risk, stable coronary heart disease (CHD) subjects and to
      prospectively validate risk screening biomarkers
Primary Objectives:

      PART A:

        -  To prospectively validate biomarkers in risk stratification among stable CHD subjects,
           i.e. evaluation of the biomarker performance in accurately predicting CV events
           including CV death, nonfatal MI, HF events

        -  To identify high-risk CHD subjects for the subsequent RCT, i.e. 15-20% of the screened
           patient population at the highest risk

      PART B

      • To demonstrate whether a personalised prevention (PPP) strategy in high-risk CHD subjects
      results in a decreased risk of cardiovascular (CV) events (CV death, nonfatal myocardial
      infarction (MI) or heart failure (HF) events) as compared to the local usual care (UC)

      Secondary Objectives:

        -  To evaluate the difference between the PPP arm to the UC arm as listed in section
           outcomes.

        -  To evaluate the health economic value of the PPP

        -  To prospectively study associations (in all enrolled subjects) between separate
           biomarkers (CERT2, hs-troponin, proBNP, Cystatin C) or their score (CoroPredict)

      In addition to the above-listed primary and secondary objectives of the study, the following
      analysis will be carried out based on the data to be collected during the trial:

        -  Effect of personalised prevention on behavioural change.

        -  Effect of behavioural change on CV outcomes and blood pressure.

        -  Identification of key components and risk factors affecting effectiveness of the PPP.

        -  Inter-relationship between nutrition and exercise will be evaluated. Nutrition
           parameters will be based on questionnaires and biomarkers (Trimethylamine N-oxide
           (TMAO), Trimethyllysine (TML), carnitines and their metabolites).

        -  Effect of the use of the CoroPrevention Tool Suite (EXPERT tool) on the agreement
           between exercise prescriptions generated by cardiovascular nurses to subjects with CVD,
           and the ESC guideline-directed exercise prescriptions

        -  Effect of greater adherence to EXPERT tool-driven exercise prescriptions by clinicians
           and subjects, on CVD risk, physical fitness, and prognosis (hospitalisations, adverse
           events, mortality) in subjects with CVD.

        -  Effect of the use of the EXPERT tool-driven medication decision support system on the
           agreement between medication prescriptions generated by cardiovascular nurses to
           subjects with CVD, and the ESC guideline-directed medication prescriptions

        -  Effect of better adherence by both clinicians and subjects to ESC guideline
           prescriptions, driven by the medication decision support system within the EXPERT tool,
           on CVD risk and prognosis (hospitalisations, adverse events, mortality) in subjects with
           CVD.

        -  Investigation of the user experience and user acceptance of the CoroPrevention Tool
           Suite.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: To demonstrate whether a PPP strategy in high-risk CHD subjects results in a decreased risk of CV events (CV death, nonfatal MI or HF events) compared to the UC
time frame: 3 years follow-up
description: • The time from randomisation to the occurrence of the first CV event included in the composite endpoint of the study (CV death, nonfatal MI, HF events) over 3 years follow-up.
measure: To evaluate the difference between PPP arm to the UC arm in
time frame: 3 years follow-up
description: o The times from randomisation to the occurrence of the specific items included in the composite endpoint (CV death, nonfatal MI, HF event) over 3 years follow-up
measure: To evaluate the difference between PPP arm to the UC arm in
time frame: 3 years follow-up
description: o The times from randomisation to the occurrence of secondary CV events (unstable angina, stroke and coronary revascularisations excluding those elective revascularisations that have been planned prior to randomisation)
measure: To evaluate the difference between PPP arm to the UC arm in
time frame: 3 years follow-up
description: o Treatment adherence; measured by compliance laboratory assessments and in the PPP group, also with activity reports
measure: To evaluate the difference between PPP arm to the UC arm in
time frame: 3 years follow-up
description: All-cause mortality
measure: To evaluate the difference between PPP arm to the UC arm in
time frame: 3 years follow-up
description: Incidence of additional clinical endpoints: diabetes mellitus type 2 (DM2), chronic kidney disease (CKD), peripheral artery disease (PAD) and hypertension
measure: To evaluate the health economic value of the PPP
time frame: 3 years follow-up
description: o A cost-effectiveness analysis of PPP versus UC will be undertaken, based on evidence from the randomised clinical trial (RCT) portion of the study, using within-trial analysis and long-term cost-effectiveness modelling for the six countries participating in the CoroPrevention trial: Finland, Poland, Greece, Portugal, Italy, and Germany.
measure: • To prospectively study associations (in all enrolled subjects) between separate risk biomarkers (CERT2, hs-troponin , proBNP, Cystatin C) or their score (CoroPredict) and
time frame: 3 years follow-up
description: Primary composite CV event (CV death, MI, HF events)
Specific CV events (CV death, nonfatal MI, HF events) separately
Specific secondary CV events (unstable angina, stroke, coronary revascularisations)
Incidence of DM2, CKD, PAD and hypertension
arm group label: Personalised prevention program (PPP)
arm group type: Experimental
description: Participants will be invited to return to the study site six times over a three year period to receive lifestyle coaching and exercise prescriptions. Eupropean Society of Cardiology/European Association of Preventive Cardiology (ESC/EAPC) -designed lifestyle counselling will be partially delivered by novel smartphone applications. Participants will also receive pharmaceutical treatment according to the ESC guideline for chronic coronary syndromes.
arm group label: Usual care (UC)
arm group type: No Intervention
description: Participants will be referred back to usual care provided by their treating physicians. It is anticipated that physicians will treat these participants according to local usual medical practices. Patients randomized to UC group will not receive any treatment recommendations nor restrictions by the study investigators or nurses.
Randomized UC patients are invited to site visits twice over a three year period.
intervention type: Behavioral
intervention name: personalised prevention program (PPP)
description: Study subjects in the PPP arm will be invited to return to the study site six times over a three-year period (at V2/start of the study, V3/mo2, V4/mo6, V5/mo12, V6/mo18 and V7/mo36) to receive lifestyle coaching and exercise prescriptions led by a delegated member of the site staff and supervised by the investigator. Information on drug treatment will also be given by the investigator. These activities will be assisted by digital tools specifically designed for this study, the CoroPrevention Tool Suite.
arm group label: Personalised prevention program (PPP)
criteria: 
gender: All
minimum age: 30 Years
maximum age: 80 Years
healthy volunteers: No
last name: Reijo Laaksonen, MD, PhD
role: Study Director
affiliation: Tampere University
last name: Hanna Marttila, MSc
phone: +358407240771
email: hanna.marttila@tuni.fi
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country: Finland
country: Germany
country: Greece
country: Italy
country: Poland
country: Portugal
responsible party type: Principal Investigator
investigator affiliation: Tampere University
investigator full name: Reijo Laaksonen
investigator title: Project Director
mesh term: Heart Diseases
mesh term: Coronary Disease
mesh term: Coronary Artery Disease
mesh term: Myocardial Ischemia
sharing ipd: Yes
ipd description: EU open access policy
ipd time frame: opens 2 years after last study patient visit, open for 18 years until IPD deletion
ipd access criteria: Steering Committee decision, application needed