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

This study has been withdrawn prior to enrollment.
Information provided by:
Hoffmann-La Roche Identifier:
First received: May 2, 2007
Last updated: November 1, 2016
Last verified: November 2016
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
Intervention Model: Parallel Assignment
Masking: None (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:

Enrollment: 0
Study Start Date: September 2007

Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT00468702

Ottawa, Canada
Sponsors and Collaborators
Hoffmann-La Roche
Study Director: Clinical Trials Hoffmann-La Roche
  More Information Identifier: NCT00468702     History of Changes
Other Study ID Numbers: RD-0014
Study First Received: May 2, 2007
Last Updated: November 1, 2016

Additional relevant MeSH terms:
Cardiovascular Abnormalities
Cardiovascular Diseases
Congenital Abnormalities processed this record on September 19, 2017