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

Tracking Information

First Received Date ^ICMJE

May 2, 2007

Last Updated Date

November 20, 2007

Start Date ^ICMJE

September 2007

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00468702 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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).

Detailed Description

Study Phase

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

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

Condition ^ICMJE

Cardiovascular Abnormalities

Intervention ^ICMJE

Device: CoaguChek S

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Withdrawn

Enrollment ^ICMJE

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years to 70 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Canada

Administrative Information

NCT ID ^ICMJE

NCT00468702

Responsible Party

Study ID Numbers ^ICMJE

RD-0014, RD000000383-2007

Study Sponsor ^ICMJE

Hoffmann-La Roche

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Clinical Trials

Hoffmann-La Roche, +1 973 235 5000

Information Provided By

Hoffmann-La Roche

Verification Date

November 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP