Trial Information
Summary: The Warfarin-SMART Study
Status: No longer recruiting
Protocol Number: X03-0023
Sponsor:
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 Phase: N/A
Study Design / Study Details:
- Purpose:
- Allocation: Randomized
- Masking: Open Label
- Control: Uncontrolled
- Assignment: Parallel
- Endpoints:
Study Type:
Interventional
Condition: Atrial Fibrillation
Intervention Type: Diagnostic Test
Intervention Name: CoaguChek S
Primary Outcome:
Key Secondary Outcomes:
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
Accepts Healthy Volunteers: No
Anticipated Start Date: July, 2004
Trial Registration Date: 11/29/2006
Date Last Updated: 09/29/2008
Link To Trial Results
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Contact:
Research Site:
Located In:
Sydney, Australia, 2050
Telephone: 973-235-5000 or 800-526-6367
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Trial listings updated: October 6, 2008 at 2:41:42 PM