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

This study has been withdrawn prior to recruitment.

First Received: May 2, 2007 Last Updated: November 20, 2007 History of Changes

Sponsored by:	Hoffmann-La Roche
Information provided by:	Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT00468702

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:	Diagnostic, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
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

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, +1 973 235 5000

More Information

No publications provided

Study ID Numbers:	RD-0014, RD000000383-2007
Study First Received:	May 2, 2007
Last Updated:	November 20, 2007
ClinicalTrials.gov Identifier:	NCT00468702 History of Changes
Health Authority:	Canada: Health Canada

Study placed in the following topic categories:

Cardiovascular Abnormalities
Congenital Abnormalities

Additional relevant MeSH terms:

Cardiovascular Abnormalities
Cardiovascular Diseases
Congenital Abnormalities

ClinicalTrials.gov processed this record on July 02, 2009