Randomized Evaluation of Long Term Anticoagulant Therapy (RE-LY) With Dabigatran Etexilate
Summary
The primary objective of this trial is to demonstrate the efficacy and safety of dabigatran etexilate in patients with non-valvular atrial fibrillation for the prevention of stroke and systemic embolism.
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Primary Purpose: Prevention
Conditions
Atrial Fibrillation
Intervention
warfarin, Dabigatran dose 1, Dabigatran dose 2
Location
1160.26.0046 Boehringer Ingelheim Investigational Site
Birmingham
Alabama
United States
Status
Completed
Source
Boehringer Ingelheim Pharmaceuticals
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00262600
- Information obtained from ClinicalTrials.gov on August 07, 2012
Medical and Biotech [MESH] Definitions
Warfarin
An anticoagulant that acts by inhibiting the synthesis of vitamin K-dependent coagulation factors. Warfarin is indicated for the prophylaxis and/or treatment of venous thrombosis and its extension, pulmonary embolism, and atrial fibrillation with embolization. It is also used as an adjunct in the prophylaxis of systemic embolism after myocardial infarction. Warfarin is also used as a rodenticide.
Lethal Dose 50
The dose amount of poisonous or toxic substance or dose of ionizing radiation required to kill 50% of the tested population.
Atrial Flutter
Rapid, irregular atrial contractions caused by a block of electrical impulse conduction in the right atrium and a reentrant wave front traveling up the inter-atrial septum and down the right atrial free wall or vice versa. Unlike ATRIAL FIBRILLATION which is caused by abnormal impulse generation, typical atrial flutter is caused by abnormal impulse conduction. As in atrial fibrillation, patients with atrial flutter cannot effectively pump blood into the lower chambers of the heart (HEART VENTRICLES).
Maximum Tolerated Dose
The highest dose of a biologically active agent given during a chronic study that will not reduce longevity from effects other than carcinogenicity. (from Lewis Dictionary of Toxicology, 1st ed)
Dose Fractionation
Administration of the total dose of radiation (RADIATION DOSAGE) in parts, at timed intervals.
Clinical Trials
The primary objective was to evaluate the safety of dabigatran etexilate(BIBR 1048) administered orally at doses of 110 and 150 mg, twice daily, for 12 weeks in patients with non-valvular...
The purposes of this study are: 1. To evaluate the long-term safety of dabigatran etexilate 2. To assess the effect of a knowledge translation intervention on patient outcomes
The purpose of this trial is to determine the comparative safety and efficacy of dabigatran etexilate 150 mg bid administered orally and warfarin PRN to maintain an INR of 2.0-3.0 for 6 mo...
Randomized, Open Label Study of Dabigatran Etexilate in Elective Percutaneous Coronary Intervention
To assess whether two doses of dabigatran etexilate (110 mg b.i.d and 150 mg b.i.d) as compared to UFH, both in addition to a standard dual antiplatelet regimen, provide sufficient anticoa...
RE-DEEM Dose Finding Study for Dabigatran Etexilate in Patients With Acute Coronary Syndrome
The purpose of this trial is to evaluate the safety and indicators of efficacy of up to 4 doses of orally administered dabigatran etexilate, administered b.i.d, compared to placebo when gi...
PubMed Articles
Dabigatran in atrial fibrillation: pharmacology and clinical trials.
The central pharmacologic approach to stroke prevention in atrial fibrillation has recently changed with the approval of dabigatran by the US Food and Drug Administration (FDA). Dabigatran is an oral...
BACKGROUND: Systemic thromboembolism and bleeding remain the two most common and serious complications of catheter ablation of atrial fibrillation. A variety of periprocedure anticoagulation strategie...
Dabigatran for stroke prevention in atrial fibrillation.
Dabigatran is a novel direct thrombin inhibitor that has recently been approved for primary and secondary stroke prevention and prevention of systemic embolism in patients with atrial fibrillation. In...
Preventing Cardioembolic Stroke in Atrial Fibrillation with Dabigatran.
Dabigatran is a direct inhibitor of thrombin that has recently been approved for primary and secondary stroke prevention and prevention of systemic embolism in patients with atrial fibrillation. The R...
This article provides an overview of the clinical profile of oral dabigatran etexilate (Pradaxa®, Pradax™) [hereafter referred to as dabigatran] when used for the prevention of stroke and systemic...
