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

Not Applicable

Completed

• Conditions: Coronary Artery Disease
• Interventions: Behavioral: Multi-disciplinary disease management approach

• Registration Number: NCT01134679
• Lead Sponsor: Laval University

Brief Summary

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

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.

Study Timeline

• Study Start: 2009-06
• Study First Submitted: 2009-07-23
• Primary Completion: 2010-06
• Study First Submitted QC: 2010-06-01
• Study First Posted: 2010-06-02
• Study Completion: 2011-06
• Status Verified: 2012-02
• Last Update Submitted: 2012-02-13
• Last Update Posted: 2012-02-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

• Percutaneous Coronary Intervention with implantation of Drug-Eluting Stent
• Prescription for Plavix and Aspirin

Exclusion Criteria

• Patients frequenting more than one pharmacy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Phone calls	Multi-disciplinary disease management approach	Disease management with close patient follow-up, using phone calls.

Primary Outcome Measures

Name	Time	Method
the number of days with available Clopidogrel and Aspirin (from pharmacy records)	1 year

Secondary Outcome Measures

Name	Time	Method
the adhesion to Clopidogrel and Aspirin as self-reported by patients	1 year

Trial Locations

Locations (1)

Institut de Cardiologie et de Pneumologie de Québec; 🇨🇦 Québec, Quebec, Canada