Trial information
The Warfarin-SMART Study
Status: No longer recruiting
Protocol number: X03-0023
Company division: Diagnostic
Official Scientific Title: The Warfarin-SMART study
Brief summary: This study will evaluate the impact of patient self-management of oral anticoagulation using the Coaguchek S, versus the current gold standard, in patients with mechanical heart valve replacement and chronic atrial fibrillation.
Study type: Interventional; Randomized; Open Label; Uncontrolled; Parallel study
Condition: Atrial Fibrillation
Intervention type: Diagnostic Test
Intervention name: CoaguChek S
Inclusion criteria:
- adult patients, >=18 years of age;
- >=1 mechanical valve or chronic (3 months) atrial fibrillation;
- warfarin/coumadin therapy for >=3 months;
- <=2mg change in warfarin dose in past 4 weeks.
Exclusion criteria:
- coagulation disorder;
- underlying liver disease;
- any condition likely to limit compliance.
Gender: Males or Females
Age limits: Min: 17 Years Max: N/A (No limit)
Accepts healthy volunteers: No
Anticipated start date: July, 2004
Trial registration date: 11/29/2006
Date last updated: 11/21/2008
Link to trial result
This trial was conducted at the following locations:
Australia
