Randomized Evaluation of Long Term Anticoagulant Therapy (RE-LY) With Dabigatran Etexilate

Completed · Phase 3

Conditions studied: Atrial Fibrillation, Stroke

In brief

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.

Key facts

Study ID

NCT00262600

Run by

Boehringer Ingelheim

People needed

18113

Starts

2005-12-01

Last updated by the study team

2019-04-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• Prosthetic heart valves requiring anticoagulation per se, or hemodynamically relevant valve disease that is expected to require surgical intervention during the course of the study
• Severe, disabling stroke within the previous 6 months, or any stroke within the previous 14 days
• Conditions associated with an increased risk of bleeding
• Contraindication to warfarin treatment
• Reversible causes of atrial fibrillation (e.g., cardiac surgery, pulmonary embolism, untreated hyperthyroidism).
• Plan to perform a pulmonary vein ablation or surgery for cure of the AF
• Severe renal impairment (estimated creatinine clearance <=30 mL/min)
• Active infective endocarditis
• Active liver disease
• Women who are pregnant, lactating, or of childbearing potential who refuse to use a medically acceptable form of contraception throughout the study
• Anaemia (haemoglobin <100g/L) or thrombocytopenia (platelet count <100 x 109/L)
• Patients who have developed transaminase elevations upon exposure to ximelagatran
• Patients who have received an investigational drug 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, has a life expectancy less than the expected duration of the trial due to concomitant disease, 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)
• Any known hypersensitivity to galactose if the warfarin used contains galactose.

Where it is running

• 1160.26.0046 Boehringer Ingelheim Investigational Site — Birmingham, Alabama, United States
• 1160.26.0057 Boehringer Ingelheim Investigational Site — Birmingham, Alabama, United States
• 1160.26.0211 Boehringer Ingelheim Investigational Site — Birmingham, Alabama, United States
• 1160.26.0206 Boehringer Ingelheim Investigational Site — Huntsville, Alabama, United States
• 1160.26.0115 Boehringer Ingelheim Investigational Site — Mobile, Alabama, United States
• 1160.26.0104 Boehringer Ingelheim Investigational Site — Lake Havasu City, Arizona, United States
• 1160.26.0304 Boehringer Ingelheim Investigational Site — Peoria, Arizona, United States
• 1160.26.0185 Boehringer Ingelheim Investigational Site — Tucson, Arizona, United States
• 1160.26.0305 Boehringer Ingelheim Investigational Site — Tucson, Arizona, United States
• 1160.26.0038 Boehringer Ingelheim Investigational Site — Hot Springs, Arkansas, United States
• 1160.26.0302 Boehringer Ingelheim Investigational Site — Jonesboro, Arkansas, United States
• 1160.26.0121 Boehringer Ingelheim Investigational Site — Little Rock, Arkansas, United States
• 1160.26.0191 Boehringer Ingelheim Investigational Site — Little Rock, Arkansas, United States
• 1160.26.0204 Boehringer Ingelheim Investigational Site — Little Rock, Arkansas, United States
• 1160.26.0213 Boehringer Ingelheim Investigational Site — Little Rock, Arkansas, United States
• 1160.26.0455 Boehringer Ingelheim Investigational Site — Little Rock, Arkansas, United States
• 1160.26.0388 Boehringer Ingelheim Investigational Site — Anaheim, California, United States
• 1160.26.0441 Boehringer Ingelheim Investigational Site — Carmichael, California, United States
• 1160.26.0145 Boehringer Ingelheim Investigational Site — French Camp, California, United States
• 1160.26.0333 Boehringer Ingelheim Investigational Site — Fullerton, California, United States
• 1160.26.0384 Boehringer Ingelheim Investigational Site — La Jolla, California, United States
• 1160.26.0091 Boehringer Ingelheim Investigational Site — La Mesa, California, United States
• 1160.26.0246 Boehringer Ingelheim Investigational Site — Lancaster, California, United States
• 1160.26.0345 Boehringer Ingelheim Investigational Site — Larkspur, California, United States
• 1160.26.0009 Boehringer Ingelheim Investigational Site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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