Trial Information

Summary: A Study of Self Testing and Telemetry in Patients With Heart Valve Replacement.

Status: Recruiting

Protocol Number: ESCAT III 10/04

Sponsor:

Company Division: Diagnostic

Official Scientific Title: ESCAT II early self controlled anticoagulation trial III

Brief Summary: This study will evaluate the effect of very low dose anticoagulation with once or twice weekly patient self-testing plus telemetry on the bleeding rate, in patients with mechanical heart valve replacement. Patients will be randomized to low dose anticoagulant plus self-management, very low dose anticoagulant with patient self-testing and telemetry once weekly, or very low dose anticoagulant with patient self-testing and telemetry twice weekly.

Study Phase: N/A

Study Design / Study Details:

• Purpose:
• Allocation: Randomized
• Masking: Open Label
• Control: Active
• Assignment: Parallel
• Endpoints:

Study Type:

Condition: Cardiovascular Abnormalities

Intervention Type: Diagnostic Test

Intervention Name: Set CoaguChek XS Systemasche

Primary Outcome:

Key Secondary Outcomes:

Inclusion Criteria:

Exclusion Criteria:

Gender: Males or Females

Age Limits: Min: 18 Years Max: 99 Years

Accepts Healthy Volunteers: No

Anticipated Start Date: December, 2005

Trial Registration Date: 12/04/2006

Date Last Updated: 12/14/2006

Link To Trial Results

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Trial listings updated: August 20, 2008 at 2:17:02 PM