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Therapeutic Areas: Cardiology/Vascular Diseases
Disease Category: Cardiovascular Abnormalities
Trial Information
A Study of Self Management and Self Testing in Patients With Heart Valve Replacement.
Status: Recruiting
Protocol Number: TELEQIN 10/03
Sponsor:
Company Division: Diagnostic
Official Scientific Title: TELEQIN
Brief Summary: This study will compare the effect of patient self-management, and patient self-testing plus telemetry, on the bleeding rate in patients with mechanical heart valve replacement. It will evaluate the telemedicine tool for patients who are not able to perform self-management.
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: March, 2004
Trial Registration Date: 12/05/2006
Date Last Updated: 12/14/2006
Link To Trial Results
E-mail: genentechclinicaltrials@druginfo.com
Research Site:
Located In:
Essen 45147
Germany
Phone: 888-662-6728 (U.S. Only)
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