CTRI/2009/091/000026CompletedPhase 3
Long term multi-center extension of dabigatran treatment in patients with atrial fibrillation who completed the RE-LY trial and a cluster randomised trial to assess the effect of a knowledge translation intervention on patient outcomes.
Boehringer Ingelheim Korea Ltd12 sites in 1 country261 target enrollmentStarted: January 21, 2009Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Enrollment
- 261
- Locations
- 12
- Primary Endpoint
- Knowledge translation:
Study Overview
Brief Summary
This study is to establish the long term safety of dabigatran etexilate and to assess the effect of a knowledge translation intervention on the prognosis, cardiovascular risk profile and quality of care in patients with atrial fibrillation (AF). A total of 261 patients are proposed to be to be recruited from India.
Study Design
- Study Type
- Interventional
- Allocation
- Computer generated randomization
- Masking
- Open Label
Eligibility Criteria
- Ages
- 18.00 Year(s) to 65.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Patients are eligible for this study if they meet the following criteria:
- •Randomization to dabigatran in RE-LY and not permanently discontinued from dabigatran at the time of RE-LY termination visit
- •Patient must require long-term treatment with oral anticoagulation and investigator determines it is clinically appropriate for patient to continue receiving oral anticoagulation.
- •Written, informed consent.
Exclusion Criteria
- •Need for anticoagulant treatment for disorders other than atrial fibrillation
- •Plan to perform a pulmonary vein ablation or surgery for cure of AF
- •Patients with prosthetic heart valves requiring anticoagulation differing from an INR of 2.0?3.0
- •Symptomatic or endoscopically documented gastroduodenal ulcer disease in the 30 days prior to the start of this trial
- •Severe renal impairment (estimated creatinine clearance ≤30 mL/min) based upon last results available from RE-LY 1160.26 (should be from within the past year)
- •Anaemia (haemoglobin <100g/L) or thrombocytopenia (platelet count <100 x 109/L) based upon last results available from RE-LY 1160.26 (should be from within the past year).
- •Uncontrolled hypertension (SBP >180 mmHg and/or DBP >100 mmHg)
- •Active liver disease, including known hepatitis A, B or C
- •Active infective endocarditis
- •Women who are pregnant, lactating or of childbearing potential who refuse to use a medically acceptable form of contraception throughout the study
- •Patients who have received an investigational drug other than dabigatran in the past 30 days or are participating in another drug study.
- •Patients considered unreliable by the investigator concerning the requirements for follow-up during the study and/or compliance with study drug administration (i.e., demonstrated study drug compliance of less than 80% in RE-LY or was noncompliant with study visits in RE-LY), or has any condition which in the opinion of the investigator would not allow safe participation in the study (e.g., drug addiction, alcohol abuse).
- •Current use of quinidine.
Outcomes
Primary Outcomes
Knowledge translation:
Time Frame: Maximum 28 months
Primary endpoints: Vascular death, stroke, myocardial infarction, non- non-CNS systemic embolism, major bleeding and hospitalization for heart failure.
Time Frame: Maximum 28 months
Secondary Outcomes
- Secondary endpoints:(Stroke (including hemorrhagic), non-CNS systemic embolism, pulmonary embolism, acute MI, DVT, and all deaths (includes deaths from bleeding))
Investigators
Study Sites (12)
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