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

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ClinicalTrials.gov Identifier: NCT01134679
Recruitment Status : Completed
First Posted : June 2, 2010
Last Update Posted : February 14, 2012
Sponsor:
Collaborator:
Fonds de la Recherche en Santé du Québec
Information provided by (Responsible Party):
Stéphane Rinfret, Laval University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Behavioral: Multi-disciplinary disease management approach Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Telephone Contacts to Improve Adherence to Dual Anti-Platelet Therapy Following Drug-Eluting Stent Implantation; A Randomized Controlled-Trial
Study Start Date : June 2009
Actual Primary Completion Date : June 2010
Actual Study Completion Date : June 2011
Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. the number of days with available Clopidogrel and Aspirin (from pharmacy records) [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. the adhesion to Clopidogrel and Aspirin as self-reported by patients [ Time Frame: 1 year ]

Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01134679


Locations
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Canada, Quebec
Institut de Cardiologie et de Pneumologie de Québec
Québec, Quebec, Canada, G1V 4G5
Sponsors and Collaborators
Laval University
Fonds de la Recherche en Santé du Québec
Investigators
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Principal Investigator: Stephane Rinfret, MD MSc Fondation IUCPQ
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Stéphane Rinfret, Professor under grant, Laval University
ClinicalTrials.gov Identifier: NCT01134679    
Other Study ID Numbers: 20424
First Posted: June 2, 2010    Key Record Dates
Last Update Posted: February 14, 2012
Last Verified: February 2012
Keywords provided by Stéphane Rinfret, Laval University:
Drug Eluting Stent
Clopidogrel
Aspirin
Additional relevant MeSH terms:
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Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Heart Diseases
 Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases