ACTRN12606000019505
Recruiting
Phase 3
A Study to Evaluate the Impact of Patient Self Management on Oral Anticoagulation of Patients with Mechanical Heart Valve Replacement and/or Chronic Atrial Fibrillation
Royal Prince Alfred Hospital Cardiothoracic Department0 sites300 target enrollmentJanuary 13, 2006
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Oral Anticoagulation
- Sponsor
- Royal Prince Alfred Hospital Cardiothoracic Department
- Enrollment
- 300
- Status
- Recruiting
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Patient has one or more mechanical valve(s) or chronic (greater than 3 months) Atrial Fibrillation. 2\. Patient has been taking Warfarin/Coumadin for at least 3 months. 3\. Patients INR has been in therapeutic range for \> 2 weeks. 4\. Patient has had no more than a \<2mg change in their warfarin dose in the last four weeks. 5\. Patient speaks English. 6\. Patient can read English. 7\. Patient has access to a telephone.
Exclusion Criteria
- •1\. Patient is known to have a coagulation disorder2\. Patient has known underlying liver disease3\. Patient has a drug or alcohol addiction that is likely to limit compliance with the study routine.4\. Patient has a visual deficit likely to limit compliance.5\. Patient failed the mini mental test (AMT)6\. Patient has any other condition that is likely to limit compliance (e.g. tremor or tactile dysfunction).
Outcomes
Primary Outcomes
Not specified
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