Trial Information

Summary: The Warfarin-SMART Study

Status: 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: 12/18/2007

Link To Trial Results

Contact:

Research Site:
Located In:
Sydney, Australia, 2077
Telephone: 973-235-5000 or 800-526-6367

 

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Trial listings updated: May 13, 2008 at 1:49:43 PM


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