Back to results(EASY)-IMProving Adherence to Clopidogrel Trial (IMPACT)) (EASY-IMPACT)
Primary Purpose
Coronary Artery Disease
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Multi-disciplinary disease management approach
Sponsored by
About this trial
This is an interventional supportive care trial for Coronary Artery Disease focused on measuring Drug Eluting Stent, Clopidogrel, Aspirin
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
Sites / Locations
- Institut de Cardiologie et de Pneumologie de Québec
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Phone calls
Arm Description
Disease management with close patient follow-up, using phone calls.
Outcomes
Primary Outcome Measures
the number of days with available Clopidogrel and Aspirin (from pharmacy records)
Secondary Outcome Measures
the adhesion to Clopidogrel and Aspirin as self-reported by patients
Full Information
NCT ID
NCT01134679
First Posted
July 23, 2009
Last Updated
February 13, 2012
Sponsor
Laval University
Collaborators
Fonds de la Recherche en Santé du Québec
1. Study Identification
Unique Protocol Identification Number
NCT01134679
Brief Title
(EASY)-IMProving Adherence to Clopidogrel Trial (IMPACT))
Acronym
EASY-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
2. Study Status
Record Verification Date
February 2012
Overall Recruitment Status
Completed
Study Start Date
June 2009 (undefined)
Primary Completion Date
June 2010 (Actual)
Study Completion Date
June 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Laval University
Collaborators
Fonds de la Recherche en Santé du Québec
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
Drug Eluting Stent, Clopidogrel, Aspirin
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
300 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Phone calls
Arm Type
Experimental
Arm Description
Disease management with close patient follow-up, using phone calls.
Intervention Type
Behavioral
Intervention Name(s)
Multi-disciplinary disease management approach
Intervention Description
Follow up with phone calls
Primary Outcome Measure Information:
Title
the number of days with available Clopidogrel and Aspirin (from pharmacy records)
Time Frame
1 year
Secondary Outcome Measure Information:
Title
the adhesion to Clopidogrel and Aspirin as self-reported by patients
Time Frame
1 year
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephane Rinfret, MD MSc
Organizational Affiliation
Fondation IUCPQ
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institut de Cardiologie et de Pneumologie de Québec
City
Québec
State/Province
Quebec
ZIP/Postal Code
G1V 4G5
Country
Canada
12. IPD Sharing Statement
Citations:
PubMed Identifier
23434769
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.
Results Reference
derived
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(EASY)-IMProving Adherence to Clopidogrel Trial (IMPACT))
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