NCT01134679

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P50-P75 for not_applicable coronary-artery-disease

Timeline
Completed

Started Jun 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2009

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 23, 2009

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 2, 2010

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
Last Updated

February 14, 2012

Status Verified

February 1, 2012

Enrollment Period

1 year

First QC Date

July 23, 2009

Last Update Submit

February 13, 2012

Conditions

Coronary Artery Disease

Keywords

Drug Eluting StentClopidogrelAspirin

Outcome Measures

Primary Outcomes (1)

  • the number of days with available Clopidogrel and Aspirin (from pharmacy records)

    1 year

Secondary Outcomes (1)

  • the adhesion to Clopidogrel and Aspirin as self-reported by patients

    1 year

Study Arms (1)

Phone calls

EXPERIMENTAL

Disease management with close patient follow-up, using phone calls.

Behavioral: Multi-disciplinary disease management approach

Interventions

Multi-disciplinary disease management approachBEHAVIORAL

Follow up with phone calls

Phone calls

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Percutaneous Coronary Intervention with implantation of Drug-Eluting Stent
  • Prescription for Plavix and Aspirin

You may not qualify if:

  • Patients frequenting more than one pharmacy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institut de Cardiologie et de Pneumologie de Québec

Québec, Quebec, G1V 4G5, Canada

Location

Related Publications (1)

  • 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.

    PMID: 23434769DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • Stephane Rinfret, MD MSc

    Fondation IUCPQ

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor under grant

Study Record Dates

First Submitted

July 23, 2009

First Posted

June 2, 2010

Study Start

June 1, 2009

Primary Completion

June 1, 2010

Study Completion

June 1, 2011

Last Updated

February 14, 2012

Record last verified: 2012-02

Locations

CA(1)