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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This study has been withdrawn prior to enrollment.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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
Cardiovascular Abnormalities
Cardiovascular Diseases
Congenital Abnormalities

ClinicalTrials.gov processed this record on November 20, 2014