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

February 13, 2012 updated by: Stéphane Rinfret, Laval University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Quebec
      • Québec, Quebec, Canada, G1V 4G5
        • Institut de cardiologie et de pneumologie de Québec

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
the number of days with available Clopidogrel and Aspirin (from pharmacy records)
Time Frame: 1 year
1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
the adhesion to Clopidogrel and Aspirin as self-reported by patients
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Laval University

Collaborators

Fonds de la Recherche en Santé du Québec

Investigators

  • Principal Investigator: Stephane Rinfret, MD MSc, Fondation IUCPQ

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2009

Primary Completion (Actual)

June 1, 2010

Study Completion (Actual)

June 1, 2011

Study Registration Dates

First Submitted

July 23, 2009

First Submitted That Met QC Criteria

June 1, 2010

First Posted (Estimate)

June 2, 2010

Study Record Updates

Last Update Posted (Estimate)

February 14, 2012

Last Update Submitted That Met QC Criteria

February 13, 2012

Last Verified

February 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20424

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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