EUCTR2008-005248-17-DKActive, not recruitingNot Applicable
RELY-ABLE long term multi-center extension of dabigatran treatmentin patients with atrial fibrillation who completed the RE-LY trial and acluster randomised trial to assess the effect of a knowledge translationintervention on patient outcomes - RELY-ABLE
Boehringer Ingelheim Inc.0 sites8,000 target enrollmentStarted: October 20, 2008Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 8,000
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •1. Randomization to dabigatran in RE-LY and not permanently discontinued from dabigatran at the time of RE-LY termination visit
- •2. Patient must require long-term treatment with oral anticoagulation and investigator determines it is clinically appropriate for patient to continue receiving oral anticoagulation.
- •3. Written, informed consent
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
Exclusion Criteria
- •1. Need for anticoagulant treatment for disorders other than atrial fibrillation
- •2. Plan to cure of AF
- •3. Patients with prosthetic heart valves
- •4. gastroduodenal ulcer disease
- •5. Severe renal impairment
- •6. Anaemia or thrombocytopenia
- •7. Uncontrolled hypertension
- •8. Active liver disease
- •9. Active infective endocarditis
- •10. Women who are pregnant, lactating or of childbearing potential who refuse to use a medically acceptable form of contraception throughout the study
- •11. Patients who have received an investigational drug other than dabigatran in the past 30 days or are participating in another drug study.
- •12. Other reasons for which Investigator determines patient icannot safely participate
- •13. Current use of quinidine
Investigators
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