<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/NCT01689493</url>
  </required_header>
  <id_info>
    <org_study_id>APHM 2010-A00933-36</org_study_id>
    <nct_id>NCT01689493</nct_id>
  </id_info>
  <brief_title>Strategy to Improve Antiplatelet Therapy Adherence After Coronary Stent Implantation</brief_title>
  <official_title>Strategy to Improve Antiplatelet Therapy Adherence After Coronary Stent Implantation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hôpital de la Timone</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hôpital de la Timone</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to assess the effectiveness of an adherence protocol&#xD;
      intervention among stented patients to improve adherence to antiplatelet therapy (primary&#xD;
      endpoint). Secondary endpoints will assess whether the intervention reduces cardiovascular&#xD;
      events (ACS, stent thrombosis, re- hospitalization and coronary angiography,&#xD;
      revascularization, all-cause mortality) and its cost-effectiveness.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      RATIONALE : Acute coronary syndrome is the first cause of mortality in cardiology.&#xD;
      Development of stent and dual antiplatelet therapy have led to important declines in&#xD;
      morbi-mortality. Despite this, the risk of recurrent events and mortality after stent&#xD;
      implantation remains substantial, especially within the first six months. Non-adherence to&#xD;
      antiplatelet therapy is the major modifiable risk factor that expose to adverse outcomes&#xD;
      following stent implantation and has been identified as the major risk factor of stent&#xD;
      thrombosis. Prior interventions to improve medication adherence in cardiovascular populations&#xD;
      have produced mixed results and have not specifically assessed compliance to antiplatelet&#xD;
      therapy in patients treated by stent implantation after acute coronary syndrome.&#xD;
&#xD;
      It is currently unknown if interventions to improve antiplatelet therapy compliance in the&#xD;
      six month after stenting discharge will improve medication adherence and clinical outcomes or&#xD;
      will be cost-effective&#xD;
&#xD;
      OBJECTIVES: investigators propose to assess the effectiveness of a multi-faceted&#xD;
      patient-centered adherence intervention among patients following stent implantation to&#xD;
      improve adherence to antiplatelet therapy (primary aim).&#xD;
&#xD;
      Secondary aims will assess whether the intervention improve :&#xD;
&#xD;
        1. Cardiovascular events : ACS, stent thrombosis, re - hospitalization and coronary&#xD;
           angiography, new revascularization, all-cause mortality&#xD;
&#xD;
        2. Cost-effectiveness.&#xD;
&#xD;
      METHOD : Investigators propose a six month, mono-site patient-level randomized controlled&#xD;
      trial to evaluate, relative to usual care, a multi-faceted patient-centered intervention to&#xD;
      improve adherence to antiplatelet treatment among stented patients following ACS. The study&#xD;
      will enroll 800 patients to intervention versus usual care for 6 months in one university&#xD;
      hospital (CHU Timone, Marseille, France). The proposed intervention will be based on several&#xD;
      conceptual frameworks (Chronic Care Model and Medication Adherence Model) and adapt elements&#xD;
      of prior successfully adherence interventions, including: collaborative care, patient&#xD;
      education, tailoring of medication regimens, and daily mobile phone short message service&#xD;
      (SMS). The primary analyses will be a comparison of adherence to antiplatelet therapy using&#xD;
      specific laboratory testing of drug effect. Secondary analyses will compare incidence of&#xD;
      clinical endpoints in both groups, cost-effectiveness analysis will be performed. All&#xD;
      analyses will be intention to treat&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>May 2011</start_date>
  <completion_date type="Actual">August 2012</completion_date>
  <primary_completion_date type="Actual">August 2012</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Adherence to antiplatelet therapy</measure>
    <time_frame>one month</time_frame>
    <description>Investigators propose to assess the effectiveness of a multi-faceted patient-centered adherence intervention among patients following stent implantation to improve adherence to antiplatelet therapy (evaluated on biological effect of antiplatelet agent).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Clinical effect of the adherence intervention protocol</measure>
    <time_frame>one and six month</time_frame>
    <description>Secondary aims will assess whether the intervention protocol is effective on cardiovascular events at one and six month ( ACS, stent thrombosis, re - hospitalization and coronary angiography, new revascularization, all-cause mortality.)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">800</enrollment>
  <condition>Coronary Artery Stent Thrombosis</condition>
  <condition>Multiple Drug Use</condition>
  <condition>Patient Compliance</condition>
  <arm_group>
    <arm_group_label>usual care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>usual care arm, without SMS reminder</description>
  </arm_group>
  <arm_group>
    <arm_group_label>patient education and daily SMS</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Multifaceted patient centered intervention including : collaborative care, patient education , and daily SMS.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>patient education and daily SMS</intervention_name>
    <description>The proposed intervention will be based on several conceptual frameworks (Chronic Care Model and Medication Adherence Model) and adapt elements of prior successfully adherence interventions, including: collaborative care, patient education, tailoring of medication regimens, and daily mobile phone short message service (SMS).</description>
    <arm_group_label>patient education and daily SMS</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        - All patients admitted with acute coronary syndrome (ACS) or more stable condition&#xD;
        undergoing angiocoronarography and implantation of one or more stent (BMS or DES).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  age&lt; 18, inability to understand consent form&#xD;
&#xD;
          -  irreversible, non-cardiac medical condition (e.g. metastatic cancer) likely to affect&#xD;
             6-month survival or ability to execute study protocol;&#xD;
&#xD;
          -  lack of telephone/cell phone;&#xD;
&#xD;
          -  no social insurance;&#xD;
&#xD;
          -  inability to perform the one and six month hospital consultation.&#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>jacques quilici, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>AP-HM</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>CHU Timone hospital . Sc CARDIOLOGIE. Rue saint Pierre.</name>
      <address>
        <city>Marseille</city>
        <zip>13005</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>September 2012</verification_date>
  <study_first_submitted>August 16, 2012</study_first_submitted>
  <study_first_submitted_qc>September 17, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 21, 2012</study_first_posted>
  <last_update_submitted>September 17, 2012</last_update_submitted>
  <last_update_submitted_qc>September 17, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 21, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hôpital de la Timone</investigator_affiliation>
    <investigator_full_name>QUILICI Jacques</investigator_full_name>
    <investigator_title>Senior Staff Member</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Thrombosis</mesh_term>
  </condition_browse>
  <!-- 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/NCT01689493
org study id: APHM 2010-A00933-36
nct id: NCT01689493
lead sponsor: 
has dmc: No
The purpose of this study is to assess the effectiveness of an adherence protocol
      intervention among stented patients to improve adherence to antiplatelet therapy (primary
      endpoint). Secondary endpoints will assess whether the intervention reduces cardiovascular
      events (ACS, stent thrombosis, re- hospitalization and coronary angiography,
      revascularization, all-cause mortality) and its cost-effectiveness.
RATIONALE : Acute coronary syndrome is the first cause of mortality in cardiology.
      Development of stent and dual antiplatelet therapy have led to important declines in
      morbi-mortality. Despite this, the risk of recurrent events and mortality after stent
      implantation remains substantial, especially within the first six months. Non-adherence to
      antiplatelet therapy is the major modifiable risk factor that expose to adverse outcomes
      following stent implantation and has been identified as the major risk factor of stent
      thrombosis. Prior interventions to improve medication adherence in cardiovascular populations
      have produced mixed results and have not specifically assessed compliance to antiplatelet
      therapy in patients treated by stent implantation after acute coronary syndrome.

      It is currently unknown if interventions to improve antiplatelet therapy compliance in the
      six month after stenting discharge will improve medication adherence and clinical outcomes or
      will be cost-effective

      OBJECTIVES: investigators propose to assess the effectiveness of a multi-faceted
      patient-centered adherence intervention among patients following stent implantation to
      improve adherence to antiplatelet therapy (primary aim).

      Secondary aims will assess whether the intervention improve :

        1. Cardiovascular events : ACS, stent thrombosis, re - hospitalization and coronary
           angiography, new revascularization, all-cause mortality

        2. Cost-effectiveness.

      METHOD : Investigators propose a six month, mono-site patient-level randomized controlled
      trial to evaluate, relative to usual care, a multi-faceted patient-centered intervention to
      improve adherence to antiplatelet treatment among stented patients following ACS. The study
      will enroll 800 patients to intervention versus usual care for 6 months in one university
      hospital (CHU Timone, Marseille, France). The proposed intervention will be based on several
      conceptual frameworks (Chronic Care Model and Medication Adherence Model) and adapt elements
      of prior successfully adherence interventions, including: collaborative care, patient
      education, tailoring of medication regimens, and daily mobile phone short message service
      (SMS). The primary analyses will be a comparison of adherence to antiplatelet therapy using
      specific laboratory testing of drug effect. Secondary analyses will compare incidence of
      clinical endpoints in both groups, cost-effectiveness analysis will be performed. All
      analyses will be intention to treat
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Adherence to antiplatelet therapy
time frame: one month
description: Investigators propose to assess the effectiveness of a multi-faceted patient-centered adherence intervention among patients following stent implantation to improve adherence to antiplatelet therapy (evaluated on biological effect of antiplatelet agent).
measure: Clinical effect of the adherence intervention protocol
time frame: one and six month
description: Secondary aims will assess whether the intervention protocol is effective on cardiovascular events at one and six month ( ACS, stent thrombosis, re - hospitalization and coronary angiography, new revascularization, all-cause mortality.)
arm group label: usual care
arm group type: No Intervention
description: usual care arm, without SMS reminder
arm group label: patient education and daily SMS
arm group type: Active Comparator
description: Multifaceted patient centered intervention including : collaborative care, patient education , and daily SMS.
intervention type: Behavioral
intervention name: patient education and daily SMS
description: The proposed intervention will be based on several conceptual frameworks (Chronic Care Model and Medication Adherence Model) and adapt elements of prior successfully adherence interventions, including: collaborative care, patient education, tailoring of medication regimens, and daily mobile phone short message service (SMS).
arm group label: patient education and daily SMS
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: jacques quilici, MD
role: Principal Investigator
affiliation: AP-HM
facility: 
country: France
responsible party type: Principal Investigator
investigator affiliation: Hôpital de la Timone
investigator full name: QUILICI Jacques
investigator title: Senior Staff Member
mesh term: Thrombosis