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

Sponsor

Laval University (Other)

Overall Status

Completed

CT.gov ID

NCT01134679

Collaborator

Fonds de la Recherche en Santé du Québec (Other)

300

Enrollment

Location

Arm

Duration (Months)

12.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Coronary Artery Disease	Behavioral: Multi-disciplinary disease management approach	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

300 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

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

Study Start Date :

Jun 1, 2009

Actual Primary Completion Date :

Jun 1, 2010

Actual Study Completion Date :

Jun 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Phone calls Disease management with close patient follow-up, using phone calls.	Behavioral: Multi-disciplinary disease management approach Follow up with phone calls

Arm

Intervention/Treatment

Experimental: Phone calls

Disease management with close patient follow-up, using phone calls.

Behavioral: Multi-disciplinary disease management approach

Follow up with phone calls

Outcome Measures

Primary Outcome Measures

the number of days with available Clopidogrel and Aspirin (from pharmacy records) [1 year]

Secondary Outcome Measures

the adhesion to Clopidogrel and Aspirin as self-reported by patients [1 year]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

Patients frequenting more than one pharmacy

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Institut de Cardiologie et de Pneumologie de Québec	Québec	Quebec	Canada	G1V 4G5

Sponsors and Collaborators

Laval University
Fonds de la Recherche en Santé du Québec

Investigators

Principal Investigator: Stephane Rinfret, MD MSc, Fondation IUCPQ

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Stéphane Rinfret, Professor under grant, Laval University

ClinicalTrials.gov Identifier:

NCT01134679

Other Study ID Numbers:

20424

First Posted:

Jun 2, 2010

Last Update Posted:

Feb 14, 2012

Last Verified:

Feb 1, 2012

Keywords provided by Stéphane Rinfret, Professor under grant, Laval University

Drug Eluting Stent

Clopidogrel

Aspirin

Additional relevant MeSH terms:

Coronary Artery Disease

Study Results

No Results Posted as of Feb 14, 2012