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

This study has been completed.
Sponsor:
Collaborator:
Fonds de la Recherche en Santé du Québec
Information provided by (Responsible Party):
Stéphane Rinfret, Laval University
ClinicalTrials.gov Identifier:
NCT01134679
First received: July 23, 2009
Last updated: February 13, 2012
Last verified: February 2012
  Purpose

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
Endpoint Classification: Efficacy Study
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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • the adhesion to Clopidogrel and Aspirin as self-reported by patients [ Time Frame: 1 year ] [ Designated as safety issue: No ]

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01134679

Locations
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
Investigators
Principal Investigator: Stephane Rinfret, MD MSc IUCPQ
  More Information

No publications provided by Laval University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Stéphane Rinfret, Professor under grant, Laval University
ClinicalTrials.gov Identifier: NCT01134679     History of Changes
Other Study ID Numbers: 20424
Study First Received: July 23, 2009
Last Updated: February 13, 2012
Health Authority: Canada: Ethics Review Committee

Keywords provided by Laval University:
Drug Eluting Stent
Clopidogrel
Aspirin

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on September 18, 2014