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Therapeutic Areas: Cardiology/Vascular Diseases
Disease Category: Cardiovascular Abnormalities
Trial Information
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:
Interventional
Condition: Cardiovascular Abnormalities
Intervention Type: Diagnostic Test
Intervention Name: Set CoaguChek XS Systemasche
Primary Outcome:
Key Secondary Outcomes:
Inclusion Criteria:
- adult patients, >=18 years of age;
- mechanical aortic, mitral or double valve replacement.
Exclusion Criteria:
- chronic gastrointestinal ulceration;
- incompatibility to anticoagulants.
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
E-mail: genentechclinicaltrials@druginfo.com
Research Site:
Located In:
Kassel 34125
Germany
Phone: 888-662-6728 (U.S. Only)
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