Randomized Evaluation of Long Term Anticoagulant Therapy (RE-LY) With Dabigatran Etexilate
- Conditions
- -I48 Atrial fibrillation and flutterAtrial fibrillation and flutterI48
- Registration Number
- PER-087-06
- Lead Sponsor
- BOEHRINGER INGELHEIM PHARMA,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Not specified
- Target Recruitment
- 0
1) Documented Atrial fibrillation (AF).
2) In addition to documented AF, patients must present one of the following additional risk factors for stroke: a) History of stroke, transient ischemic attack or systemic embolism. b) Left ventricular ejection fraction <40%. c) Symptomatic heart failure, documented as NYHA Class 2 or higher. d) Age ≥ 75 years. e) Age ≥ 65 years and one of the following additional risk factors: Diabetes mellitus in treatment. OR, Coronary disease documented. OR, Hypertension that requires medical treatment.
3) Age ≥ 18 years at admission.
4) Written informed consent.
1) History of cardiac valvular disorders.
2) Severe, disabling stroke in the last 6 months or any stroke in the last 14 days.
3) Conditions associated with increased risk of bleeding: a) Major surgery in the last month. b) Surgery or intervention planned in the next 3 months. c) History of intracranial, intraocular, spinal, retroperitoneal or non-traumatic intra-articular bleeding. d) Gastrointestinal bleeding in the last year. e) Gastroduodenal ulcerative disease symptomatically or endoscopically documented in the last 30 days. f) Haemorrhagic disorder or hemorrhagic diathesis. g) Need for anticoagulant treatment for other disorders other than atrial fibrillation. h) Fibrinolytic agents in the 48 hours before entering the study. i) Uncontrolled hypertension. j) Recent malignancy or radiotherapy and with expectation of
survival less than 3 years.
4) Contraindication for treatment with warfarin.
5) Reversible causes of atrial fibrillation.
6) Plan to perform pulmonary vein ablation or surgery for the healing of AF.
7) Severe renal dysfunction.
8) Active infectious endocarditis
9) Active liver disease.
10) Pregnant or fertile women who refuse to use a medically acceptable method of contraception during the entire study.
11) Anemia or thrombocytopenia.
12) Patients who presented elevations of transaminases when exposed to ximelagatran.
13) Patients who received an experimental medication in the last 30 days.
14) Patients that the researcher considers unreliable in terms of follow-up during the study and / or compliance with the administration of the study medication, with a life expectancy shorter than the estimated duration of the study due to concomitant or presenting diseases. Any condition will not allow safe participation in the study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br>Outcome name:Clinical evaluation to determine the time in which a stroke occurred. Defined as a focal neurological deficit of presumed vascular origin, lasting 24 hours or more or producing death. Any suspected stroke should be confirmed with CT or MRI.<br>Measure:Incidence of all strokes.<br>Timepoints:At 36 months.<br>
- Secondary Outcome Measures
Name Time Method