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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2007-09-30

Brief Summary

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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

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Conditions

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Cardiovascular Abnormalities

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Interventions

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CoaguChek S

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

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Ottawa, , Canada

Site Status

Countries

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Canada

Other Identifiers

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RD000000383-2007

Identifier Type: -

Identifier Source: secondary_id

RD-0014