Trial information
A Study of Self Testing and Telemetry in Patients With Heart Valve Replacement.
Status: Recruiting
Protocol number: ESCAT III 10/04
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 type: Interventional; Randomized; Open Label; Active; Parallel study
Condition: Cardiovascular Abnormalities
Intervention type: Diagnostic Test
Intervention name: Set CoaguChek XS Systemasche
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: 9/29/2008
Link to trial result
This trial is being conducted at the following locations:
Austria
Germany
- Bad Oeynhausen
- Kassel
- Lahr
- Ludwigshafen
- Magdeburg
- Oldenburg
Italy
Switzerland
