Clinical trial NCT01134679: (EASY)-IMProving Adherence to Clopidogrel Trial (IMPACT))
Official title: Telephone Contacts to Improve Adherence to Dual Anti-Platelet Therapy Following Drug-Eluting Stent Implantation; A Randomized Controlled-Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Disease
Keywords: Drug Eluting Stent
Clopidogrel
Aspirin
Lead sponsor: Laval University
Sponsor class: OTHER
Collaborators: name: Fonds de la Recherche en Santé du Québec
First posted: 2010-06-02
Enrollment: 300
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility 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

Primary outcomes:
measure: the number of days with available Clopidogrel and Aspirin (from pharmacy records)
timeFrame: 1 year
Secondary outcomes:
measure: the adhesion to Clopidogrel and Aspirin as self-reported by patients
timeFrame: 1 year
Other outcomes:
Locations:
city: Québec
country: Canada
facility: Institut de Cardiologie et de Pneumologie de Québec
state: Quebec
Study officials:
affiliation: Fondation IUCPQ
name: Stephane Rinfret, MD MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rinfret S, Rodes-Cabau J, Bagur R, Dery JP, Dorais M, Larose E, Barbeau G, Gleeton O, Nguyen CM, Noel B, Proulx G, Roy L, Taillon I, De Larochelliere R, Bertrand OF; EASY-IMPACT Investigators. Telephone contact to improve adherence to dual antiplatelet therapy after drug-eluting stent implantation. Heart. 2013 Apr;99(8):562-9. doi: 10.1136/heartjnl-2012-303004. Epub 2013 Feb 23.