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Completed

NCT Number: NCT01134679

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

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.

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Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institut de Cardiologie et de Pneumologie de Québec

Québec, Quebec, G1V 4G5, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Patients frequenting more than one pharmacy

Treatment and study plan

Multi-disciplinary disease management approach

Behavioral

Follow up with phone calls

Primary outcomes

  1. the number of days with available Clopidogrel and Aspirin (from pharmacy records)

    Time frame: 1 year

Secondary outcomes

  1. the adhesion to Clopidogrel and Aspirin as self-reported by patients

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

Laval University

Other

Collaborators

  • Fonds de la Recherche en Santé du Québec

Registry information

Official study title

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

Acronym: EASY-IMPACT

Important dates

Study start
2009
Primary completion
2010
Study completion
2011
First posted
Jun 2, 2010
Registry last updated
Feb 14, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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