NCT01134679

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 300 (actual)
• Sponsor: Laval University · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Coronary Artery Disease

Interventions

Type	Name	Description
BEHAVIORAL	Multi-disciplinary disease management approach	Follow up with phone calls

Timeline

• Start date: 2009-06-01
• Primary completion: 2010-06-01
• Completion: 2011-06-01
• First posted: 2010-06-02
• Last updated: 2012-02-14

Locations

1 site across 1 country: Canada