Strategy to Improve Antiplatelet Therapy Adherence After Coronary Stent Implantation

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.

Study Overview

• Status: Completed
• Conditions: Multiple Drug Use; Patient Compliance; Coronary Artery Stent Thrombosis
• Intervention / Treatment: Behavioral: patient education and daily SMS

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 800
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Marseille, France, 13005
    • CHU Timone hospital . Sc CARDIOLOGIE. Rue saint Pierre.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

- All patients admitted with acute coronary syndrome (ACS) or more stable condition undergoing angiocoronarography and implantation of one or more stent (BMS or DES).

Exclusion Criteria:

• age< 18, inability to understand consent form
• irreversible, non-cardiac medical condition (e.g. metastatic cancer) likely to affect 6-month survival or ability to execute study protocol;
• lack of telephone/cell phone;
• no social insurance;
• inability to perform the one and six month hospital consultation.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: usual care; usual care arm, without SMS reminder
Active Comparator: patient education and daily SMS; Multifaceted patient centered intervention including : collaborative care, patient education , and daily SMS.	Behavioral: patient education and daily SMS; 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adherence to antiplatelet therapy	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).	one month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical effect of the adherence intervention protocol	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.)	one and six month

Collaborators and Investigators

• Sponsor: Hôpital de la Timone
• Investigators: Principal Investigator: jacques quilici, MD, AP-HM

Study record dates

Study Major Dates

• Study Start: May 1, 2011
• Primary Completion (Actual): August 1, 2012
• Study Completion (Actual): August 1, 2012

Study Registration Dates

• First Submitted: August 16, 2012
• First Submitted That Met QC Criteria: September 17, 2012
• First Posted (Estimate): September 21, 2012

Study Record Updates

• Last Update Posted (Estimate): September 21, 2012
• Last Update Submitted That Met QC Criteria: September 17, 2012
• Last Verified: September 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Embolism and Thrombosis; Thrombosis
• Other Study ID Numbers: APHM 2010-A00933-36