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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01134679
Acronym
EASY-IMPACT
Enrollment
300
Registered
2010-06-02
Start date
2009-06-30
Completion date
2011-06-30
Last updated
2012-02-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Artery Disease

Keywords

Drug Eluting Stent, Clopidogrel, Aspirin

Brief summary

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.

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.

Interventions

BEHAVIORALMulti-disciplinary disease management approach

Follow up with phone calls

Sponsors

Fonds de la Recherche en Santé du Québec
CollaboratorOTHER_GOV
Laval University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
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

Design outcomes

Primary

MeasureTime frame
the number of days with available Clopidogrel and Aspirin (from pharmacy records)1 year

Secondary

MeasureTime frame
the adhesion to Clopidogrel and Aspirin as self-reported by patients1 year

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026