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

Cardiovascular Abnormalities Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00468702
• Other study ID #: RD-0014
• Secondary ID: RD000000383-2007
• Status: Withdrawn
• Phase: N/A
• First received: May 2, 2007
• Last updated: November 1, 2016
• Start date: September 2007

Study information

• Verified date: November 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Cardiovascular Abnormalities

Intervention

Device:
• CoaguChek S

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Canada,