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

This study has been completed.
Fonds de la Recherche en Santé du Québec
Information provided by (Responsible Party):
Stéphane Rinfret, Laval University Identifier:
First received: July 23, 2009
Last updated: February 13, 2012
Last verified: February 2012
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 Intervention
Coronary Artery Disease
Behavioral: Multi-disciplinary disease management approach

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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

Further study details as provided by Laval University:

Primary Outcome Measures:
  • the number of days with available Clopidogrel and Aspirin (from pharmacy records) [ Time Frame: 1 year ]

Secondary Outcome Measures:
  • the adhesion to Clopidogrel and Aspirin as self-reported by patients [ Time Frame: 1 year ]

Enrollment: 300
Study Start Date: June 2009
Study Completion Date: June 2011
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Phone calls
Disease management with close patient follow-up, using phone calls.
Behavioral: Multi-disciplinary disease management approach
Follow up with phone calls

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.

Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT01134679

Canada, Quebec
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
Principal Investigator: Stephane Rinfret, MD MSc IUCPQ
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Stéphane Rinfret, Professor under grant, Laval University Identifier: NCT01134679     History of Changes
Other Study ID Numbers: 20424
Study First Received: July 23, 2009
Last Updated: February 13, 2012

Keywords provided by Laval University:
Drug Eluting Stent

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases
Platelet Aggregation Inhibitors
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs processed this record on March 28, 2017