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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00468702
Recruitment Status : Withdrawn
First Posted : May 3, 2007
Last Update Posted : November 2, 2016
Information provided by:
Hoffmann-La Roche

Brief Summary:
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 or disease Intervention/treatment Phase
Cardiovascular Abnormalities Device: CoaguChek S Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Postoperative Canadian Oral Anticoagulation Self-Management (Post-COAGS) Trial
Study Start Date : September 2007

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

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 identifier (NCT number): NCT00468702

Ottawa, Canada
Sponsors and Collaborators
Hoffmann-La Roche
Study Director: Clinical Trials Hoffmann-La Roche Identifier: NCT00468702     History of Changes
Other Study ID Numbers: RD-0014
First Posted: May 3, 2007    Key Record Dates
Last Update Posted: November 2, 2016
Last Verified: November 2016

Additional relevant MeSH terms:
Cardiovascular Abnormalities
Cardiovascular Diseases
Congenital Abnormalities