(EASY)-IMProving Adherence to Clopidogrel Trial (IMPACT))

Study Overview
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Brief Summary
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The purpose of this study is to test the impact of a multidisciplinary approach to improve the adhesion and persistence to Clopidogrel therapy. A simple and inexpensive therapy management involving a tighter monitoring of patients by nurses and pharmacists will improve the persistence and adhesion to Clopidogrel and Aspirin after the implantation of drug-eluting stents.

Detailed Description
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Optimal treatment with Clopidogrel and Aspirin is critical for preventing complications after implantation of drug-eluting stents (DES). The premature cessation of Clopidogrel is a well recognized factor of thrombosis of stents, especially DES. Indeed, there remains a large portion of patients that prematurely stop clopidogrel. No study has demonstrated that a therapeutic management program could improve patient compliance to their antiplatelets. Through an open-label clinical study, two groups of patients who just received their DES will be compared: one with the usual protocol (consisting of seeing the cardiologist 6 weeks after the intervention) and one with the normal care supplemented by a simple and efficient follow-up (consisting of phone calls at 7 days, 1 month, 6 months and 9 months explaining the importance of antiplatelet therapy, evaluating the health of the patient and well received prescription from the pharmacy). Patients in both groups will receive a prescription to Clopidogrel and Aspirin (for 1 month), with 11 renewals.

Official Title
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Telephone Contacts to Improve Adherence to Dual Anti-Platelet Therapy Following Drug-Eluting Stent Implantation; A Randomized Controlled-Trial

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Behavioral: Multi-disciplinary disease management approach


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Percutaneous Coronary Intervention with implantation of Drug-Eluting Stent Prescription for Plavix and Aspirin Exclusion Criteria: Patients frequenting more than one pharmacy
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Phone calls<br>Disease management with close patient follow-up, using phone calls. | Behavioral: Multi-disciplinary disease management approach<br>* Follow up with phone calls<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the number of days with available Clopidogrel and Aspirin (from pharmacy records) |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the adhesion to Clopidogrel and Aspirin as self-reported by patients |  | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Drug Eluting Stent, Clopidogrel, Aspirin