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

L

Laval University

Status

Completed

Conditions

Coronary Artery Disease

Treatments

Behavioral: Multi-disciplinary disease management approach

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Full 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.

Enrollment

300 patients

Sex

All

Volunteers

No 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

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

300 participants in 1 patient group

Phone calls
Experimental group
Description:
Disease management with close patient follow-up, using phone calls.
Treatment:
Behavioral: Multi-disciplinary disease management approach

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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