Postoperative Canadian Oral Anticoagulation Self-Management (Post-COAGS) Trial

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by:
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00468702
First received: May 2, 2007
Last updated: November 20, 2007
Last verified: November 2007
  Purpose

This study will measure the efficacy and safety of an early postoperative anticoagulation self-management program, using the CoaguChek S device, in patients undergoing mechanical valve replacements. Patients will be randomized into a study group (self-management) or a control group (physician management).


Condition Intervention
Cardiovascular Abnormalities
Device: CoaguChek S

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Postoperative Canadian Oral Anticoagulation Self-Management (Post-COAGS) Trial

Further study details as provided by Hoffmann-La Roche:

Study Start Date: September 2007
  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • adult patients, 18-70 years of age;
  • recipient of a mechanical heart valve (aortic and/or mitral), +/- CABG, +/- postoperative atrial fibrillation.

Exclusion Criteria:

  • recipient of a bioprosthetic valve;
  • post-operative thrombotic events;
  • pre-operative utilization of oral anticoagulation.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00468702

Locations
Canada
Ottawa, Canada
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00468702     History of Changes
Other Study ID Numbers: RD-0014, RD000000383-2007
Study First Received: May 2, 2007
Last Updated: November 20, 2007
Health Authority: Canada: Health Canada

Additional relevant MeSH terms:
Congenital Abnormalities
Cardiovascular Abnormalities
Cardiovascular Diseases

ClinicalTrials.gov processed this record on April 16, 2014