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

Coronary Artery Disease Clinical Trial

— EASY-IMPACT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01134679
• Other study ID #: 20424
• Status: Completed
• Phase: N/A
• First received: July 23, 2009
• Last updated: February 13, 2012
• Start date: June 2009
• Est. completion date: June 2011

Study information

• Verified date: February 2012
• Source: Laval University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: June 2011
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Behavioral:
• Multi-disciplinary disease management approach
Follow up with phone calls

Locations

Country	Name	City	State
Canada	Institut de Cardiologie et de Pneumologie de Québec	Québec	Quebec

Sponsors (2)

Lead Sponsor	Collaborator
Laval University	Fonds de la Recherche en Santé du Québec

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the number of days with available Clopidogrel and Aspirin (from pharmacy records)		1 year	Yes
Secondary	the adhesion to Clopidogrel and Aspirin as self-reported by patients		1 year	No