Postoperative Canadian Oral Anticoagulation Self-management (Post-COAGS) Trial
Sponsor
Hoffmann-La Roche (Industry)
Overall Status
Withdrawn
CT.gov ID
NCT00468702
Collaborator
(none)
0
1
Study Details
Study Description
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 |
|---|---|---|
|
N/A |
Study Design
Study Type:
Interventional
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
:
Sep 1, 2007
Outcome Measures
Primary Outcome Measures
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 70 Years
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
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Ottawa | Canada |
Sponsors and Collaborators
- Hoffmann-La Roche
Investigators
- Study Director: Clinical Trials, Hoffmann-La Roche
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
,
,
ClinicalTrials.gov Identifier:
NCT00468702
Other Study ID Numbers:
- RD-0014
- RD000000383-2007
First Posted:
May 3, 2007
Last Update Posted:
Nov 2, 2016
Last Verified:
Nov 1, 2016
Additional relevant MeSH terms: