<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/NCT03823547</url>
  </required_header>
  <id_info>
    <org_study_id>Hart Beter/FORCE-ACS</org_study_id>
    <nct_id>NCT03823547</nct_id>
  </id_info>
  <brief_title>Future Optimal Research and Care Evaluation</brief_title>
  <acronym>FORCE-ACS</acronym>
  <official_title>Future Optimal Research and Care Evaluation: On the Way to &quot;Personalized Medicine&quot; With an Ongoing Registry of Patients in Daily Clinical Practice (Hart Beter/ FORCE-ACS)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>J.M. ten Berg</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Vereniging Hart-Beter</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>St. Antonius Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>ZonMw: The Netherlands Organisation for Health Research and Development</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>AstraZeneca</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>St. Antonius Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Rationale: Acute coronary syndrome (ACS) is the leading cause of death worldwide. To improve&#xD;
      cardiovascular care, research is needed. Current guidelines are mainly based on well&#xD;
      controlled RCT's, though evaluation of the impact of such RCT's in the real world is missing.&#xD;
      In order to evaluate the impact and to overcome certain limitations of RCT's, a more&#xD;
      practical approach is required. In this sense the use of nonrandomized observational studies&#xD;
      is an important tool for determining the effectiveness of a therapy in routine clinical&#xD;
      practice. One way to gain insight in characteristics of patients presenting in daily clinical&#xD;
      practice, is to simply register these characteristics in a prospective manner with adequate&#xD;
      follow up.&#xD;
&#xD;
      Objective: To create an ongoing registry for evaluation of clinical long-term impact of&#xD;
      diagnostics, various treatments and devices used for ACS, for research and evaluation of&#xD;
      quality of care and to evaluate and improve regional quality of care and cooperation between&#xD;
      PCI and non-PCI centers.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Rationale:&#xD;
&#xD;
      Acute coronary syndrome (ACS) is the leading cause of death worldwide. To improve&#xD;
      cardiovascular care, research is needed. Current guidelines are mainly based on well&#xD;
      controlled RCT's, though evaluation of the impact of such RCT's in the real world is missing.&#xD;
      Different clinical settings, non-ideal therapy adherence and broader patient populations in&#xD;
      the real world than those studied in traditional RCTs may however provide different results.&#xD;
      Furthermore, RCTs are intrinsically limited to answer questions about a specific population&#xD;
      of interest, require substantial resource investments and may have limitations in&#xD;
      investigating certain issues for ethical reasons.&#xD;
&#xD;
      In order to evaluate the impact and to overcome certain limitations of RCT's, a more&#xD;
      practical approach is required. In this sense the use of nonrandomized observational studies&#xD;
      is an important tool for determining the effectiveness of a therapy in routine clinical&#xD;
      practice. One way to gain insight in characteristics of patients presenting in daily clinical&#xD;
      practice, is to simply register these characteristics in a prospective manner with adequate&#xD;
      follow up. These characteristics may include clinical parameters but also possibly genetic&#xD;
      information. Such a detailed registry is now possible due to improvements in information&#xD;
      technology, as electronic patient records permit more (semi-) automatic and uniform capture&#xD;
      of clinical parameters and outcomes. While observational studies may often be limited in&#xD;
      their ability to account for confounding and bias due to patient selection, recent evidence&#xD;
      has shown that by careful use of advanced statistical analytical methods and open reporting&#xD;
      paradigms the quality of the level of evidence is excellent.&#xD;
&#xD;
      Objectives:&#xD;
&#xD;
        1. To create a database for future research, especially in the view of personalized&#xD;
           medicine, and quality of care.&#xD;
&#xD;
        2. To evaluate clinical long-term impact of medication, devices and diagnostic tools used&#xD;
           for patients with an ACS.&#xD;
&#xD;
        3. To test the efficacy and safety of any new drug/device versus the current treatment and&#xD;
           the results of any drug/device in daily practice versus in trials&#xD;
&#xD;
        4. To evaluate routine follow-up and current health-care pathways in patients with acute&#xD;
           coronary syndrome in the Dutch healthcare system in terms of mortality, recurrent&#xD;
           ischemic events, recurrent hospital admissions and quality of life&#xD;
&#xD;
        5. To evaluate the use of risk scores (e.g. PRECISE-DAPT score, DAPT-score) to define the&#xD;
           optimal duration of antiplatelet drugs&#xD;
&#xD;
        6. To evaluate follow-up of patients referred to general practitioners as compared to of&#xD;
           patients continued to be treated by cardiologists&#xD;
&#xD;
        7. To increase adherence to current guidelines, taking into account the ongoing&#xD;
           improvements of modern patient care and future changes of treatment guidelines in&#xD;
           patients with ACS in order to improve secondary prevention in terms of reducing&#xD;
           recurrent ischemic events and preventing adverse outcomes, such as bleeding&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">January 1, 2015</start_date>
  <completion_date type="Anticipated">June 30, 2050</completion_date>
  <primary_completion_date type="Anticipated">June 30, 2050</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>3 Years</target_duration>
  <primary_outcome>
    <measure>Number of participants with</measure>
    <time_frame>3 years</time_frame>
    <description>All-cause mortality&#xD;
Myocardial infarction&#xD;
Stent thrombosis&#xD;
Stroke&#xD;
Revascularisation&#xD;
All bleeding requiring medical evaluation</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of participants with</measure>
    <time_frame>3 years</time_frame>
    <description>mortality classification into cause-of-death (i.e cardiovascular, cardiac, vascular, cerebrovascular, death due to bleeding)&#xD;
bleeding classification according to different bleeding criteria (i.e. TIMI, BARC, GUSTO, PLATO)&#xD;
cessation (and duration) of antiplatelet therapy after ACS&#xD;
patient related outcome measures, as reported in quality of life questionnaires (e.g. SF-12, Seattle Angina Questionnaires)</description>
  </secondary_outcome>
  <enrollment type="Anticipated">99999</enrollment>
  <condition>Acute Coronary Syndrome</condition>
  <condition>Myocardial Infarction</condition>
  <eligibility>
    <study_pop>
      <textblock>
        All patients admitted to the hospital ward with acute coronary syndrome or symptoms&#xD;
        suggestive for acute coronary syndrome are invited to participate in the registry.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All patients presenting with ACS&#xD;
&#xD;
          -  Age ≥ 18 years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  No oral or signed informed consent available.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Johan Dekker, Drs.</last_name>
    <role>Study Chair</role>
    <affiliation>St. Antonius Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Dean R.P.P. Chan Pin Yin, MD</last_name>
    <phone>088 - 320 12 28</phone>
    <email>d.chanpinyin@antoniusziekenhuis.nl</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Jur M. Ten Berg, MD, PhD</last_name>
    <phone>088 - 320 13 82</phone>
    <email>j.ten.berg@antoniusziekenhuis.nl</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Gelre Ziekenhuizem</name>
      <address>
        <city>Apeldoorn</city>
        <state>Gelderland</state>
        <zip>7334 DZ</zip>
        <country>Netherlands</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>D. M. Nicastia, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Rijnstate Arnhem</name>
      <address>
        <city>Arnhem</city>
        <state>Gelderland</state>
        <zip>6815 AD</zip>
        <country>Netherlands</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>R. M. Tjon, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Gelderse Vallei</name>
      <address>
        <city>Ede</city>
        <state>Gelderland</state>
        <zip>6716 RP</zip>
        <country>Netherlands</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>R. Walhout, MD, PhD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Ziekenhuis Rivierenland</name>
      <address>
        <city>Tiel</city>
        <state>Gelderland</state>
        <zip>4002 WP</zip>
        <country>Netherlands</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>J. Langerveld, MD, PhD</last_name>
    </contact>
  </location>
  <location_countries>
    <country>Netherlands</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 25, 2019</study_first_submitted>
  <study_first_submitted_qc>January 29, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 30, 2019</study_first_posted>
  <last_update_submitted>January 29, 2019</last_update_submitted>
  <last_update_submitted_qc>January 29, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 30, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>St. Antonius Hospital</investigator_affiliation>
    <investigator_full_name>J.M. ten Berg</investigator_full_name>
    <investigator_title>Principle investigator</investigator_title>
  </responsible_party>
  <keyword>DAPT</keyword>
  <keyword>Dual Antiplatelet Therapy</keyword>
  <keyword>Myocardial infarction</keyword>
  <keyword>Acute Coronary Syndrome</keyword>
  <keyword>Ticagrelor</keyword>
  <keyword>Prasugrel</keyword>
  <keyword>Clopidogrel</keyword>
  <keyword>Thrombosis</keyword>
  <keyword>Myocardial Ischemia</keyword>
  <keyword>Platelet aggregation inhibitors</keyword>
  <keyword>Risk scores</keyword>
  <keyword>Cardiovascular diseases</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Myocardial Infarction</mesh_term>
    <mesh_term>Acute Coronary Syndrome</mesh_term>
    <mesh_term>Infarction</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </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/NCT03823547
org study id: Hart Beter/FORCE-ACS
nct id: NCT03823547
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Rationale: Acute coronary syndrome (ACS) is the leading cause of death worldwide. To improve
      cardiovascular care, research is needed. Current guidelines are mainly based on well
      controlled RCT's, though evaluation of the impact of such RCT's in the real world is missing.
      In order to evaluate the impact and to overcome certain limitations of RCT's, a more
      practical approach is required. In this sense the use of nonrandomized observational studies
      is an important tool for determining the effectiveness of a therapy in routine clinical
      practice. One way to gain insight in characteristics of patients presenting in daily clinical
      practice, is to simply register these characteristics in a prospective manner with adequate
      follow up.

      Objective: To create an ongoing registry for evaluation of clinical long-term impact of
      diagnostics, various treatments and devices used for ACS, for research and evaluation of
      quality of care and to evaluate and improve regional quality of care and cooperation between
      PCI and non-PCI centers.
Rationale:

      Acute coronary syndrome (ACS) is the leading cause of death worldwide. To improve
      cardiovascular care, research is needed. Current guidelines are mainly based on well
      controlled RCT's, though evaluation of the impact of such RCT's in the real world is missing.
      Different clinical settings, non-ideal therapy adherence and broader patient populations in
      the real world than those studied in traditional RCTs may however provide different results.
      Furthermore, RCTs are intrinsically limited to answer questions about a specific population
      of interest, require substantial resource investments and may have limitations in
      investigating certain issues for ethical reasons.

      In order to evaluate the impact and to overcome certain limitations of RCT's, a more
      practical approach is required. In this sense the use of nonrandomized observational studies
      is an important tool for determining the effectiveness of a therapy in routine clinical
      practice. One way to gain insight in characteristics of patients presenting in daily clinical
      practice, is to simply register these characteristics in a prospective manner with adequate
      follow up. These characteristics may include clinical parameters but also possibly genetic
      information. Such a detailed registry is now possible due to improvements in information
      technology, as electronic patient records permit more (semi-) automatic and uniform capture
      of clinical parameters and outcomes. While observational studies may often be limited in
      their ability to account for confounding and bias due to patient selection, recent evidence
      has shown that by careful use of advanced statistical analytical methods and open reporting
      paradigms the quality of the level of evidence is excellent.

      Objectives:

        1. To create a database for future research, especially in the view of personalized
           medicine, and quality of care.

        2. To evaluate clinical long-term impact of medication, devices and diagnostic tools used
           for patients with an ACS.

        3. To test the efficacy and safety of any new drug/device versus the current treatment and
           the results of any drug/device in daily practice versus in trials

        4. To evaluate routine follow-up and current health-care pathways in patients with acute
           coronary syndrome in the Dutch healthcare system in terms of mortality, recurrent
           ischemic events, recurrent hospital admissions and quality of life

        5. To evaluate the use of risk scores (e.g. PRECISE-DAPT score, DAPT-score) to define the
           optimal duration of antiplatelet drugs

        6. To evaluate follow-up of patients referred to general practitioners as compared to of
           patients continued to be treated by cardiologists

        7. To increase adherence to current guidelines, taking into account the ongoing
           improvements of modern patient care and future changes of treatment guidelines in
           patients with ACS in order to improve secondary prevention in terms of reducing
           recurrent ischemic events and preventing adverse outcomes, such as bleeding
observational model: Cohort
time perspective: Prospective
measure: Number of participants with
time frame: 3 years
description: All-cause mortality
Myocardial infarction
Stent thrombosis
Stroke
Revascularisation
All bleeding requiring medical evaluation
measure: Number of participants with
time frame: 3 years
description: mortality classification into cause-of-death (i.e cardiovascular, cardiac, vascular, cerebrovascular, death due to bleeding)
bleeding classification according to different bleeding criteria (i.e. TIMI, BARC, GUSTO, PLATO)
cessation (and duration) of antiplatelet therapy after ACS
patient related outcome measures, as reported in quality of life questionnaires (e.g. SF-12, Seattle Angina Questionnaires)
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Johan Dekker, Drs.
role: Study Chair
affiliation: St. Antonius Hospital
last name: Dean R.P.P. Chan Pin Yin, MD
phone: 088 - 320 12 28
email: d.chanpinyin@antoniusziekenhuis.nl
last name: Jur M. Ten Berg, MD, PhD
phone: 088 - 320 13 82
email: j.ten.berg@antoniusziekenhuis.nl
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
country: Netherlands
responsible party type: Sponsor-Investigator
investigator affiliation: St. Antonius Hospital
investigator full name: J.M. ten Berg
investigator title: Principle investigator
mesh term: Myocardial Infarction
mesh term: Acute Coronary Syndrome
mesh term: Infarction
sharing ipd: Undecided