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

Roche

Status: Withdrawn

Conditions: Cardiovascular Abnormalities

Treatments: Device: CoaguChek S

Study type: Interventional

Funder types: Industry

Identifiers

NCT00468702

RD000000383-2007

RD-0014

Details and patient eligibility

About

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).

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)