Back to resultsPostoperative Canadian Oral Anticoagulation Self-management (Post-COAGS) Trial
Primary Purpose
Cardiovascular Abnormalities
Status
Withdrawn
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
CoaguChek S
Sponsored by
About this trial
This is an interventional diagnostic trial for Cardiovascular Abnormalities
Eligibility 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.
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00468702
Brief Title
Postoperative Canadian Oral Anticoagulation Self-management (Post-COAGS) Trial
Official Title
Postoperative Canadian Oral Anticoagulation Self-Management (Post-COAGS) Trial
Study Type
Interventional
2. Study Status
Record Verification Date
November 2016
Overall Recruitment Status
Withdrawn
Study Start Date
September 2007 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Hoffmann-La Roche
4. Oversight
5. 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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiovascular Abnormalities
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
CoaguChek S
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
City
Ottawa
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
Postoperative Canadian Oral Anticoagulation Self-management (Post-COAGS) Trial
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