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

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

December 6, 2005

Last Updated Date

April 23, 2009

Start Date ^†

November 2005

Current Primary Outcome Measures ^†

Incidence of stroke (including hemorrhagic) and systemic embolism [ Time Frame: 3.5 years ]

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00262600 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

Incidence of stroke (including hemorrhagic), systemic embolism, all death Incidence of stroke (including hemorrhagic), systemic embolism, pulmonary embolism, acute myocardial infarction, or vascular deaths (including deaths from bleeding) [ Time Frame: 3.4 years ]

Original Secondary Outcome Measures ^†

Descriptive Information

Brief Title ^†

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

Official Title ^†

Randomized Evaluation of Long Term Anticoagulant Therapy (RE-LY) Comparing the Efficacy and Safety of Two Blinded Doses of Dabigatran Etexilate With Open Label Warfarin for the Prevention of Stroke and Systemic Embolism in Patients With Non-Valvular Atrial Fibrillation: Prospective, Multi-Centre, Parallel-Group, Non-Inferiority Trial (RE-LY Study)

Brief 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

Detailed Description

Study Phase

Phase III

Study Type ^†

Interventional

Study Design ^†

Prevention, Parallel Assignment, Safety/Efficacy Study

Condition ^†

Atrial Fibrillation
Cerebrovascular Accident

Intervention ^†

Drug: Dabigatran etexilate
Drug: Warfarin

Study Arms / Comparison Groups

Publications *

Ezekowitz MD, Connolly S, Parekh A, Reilly PA, Varrone J, Wang S, Oldgren J, Themeles E, Wallentin L, Yusuf S. Rationale and design of RE-LY: randomized evaluation of long-term anticoagulant therapy, warfarin, compared with dabigatran. Am Heart J. 2009 May;157(5):805-10, 810.e1-2.

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Active, not recruiting

Enrollment ^†

18000

Completion Date

Estimated Primary Completion Date

March 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^†

Inclusion Criteria:

Patients with non-valvular atrial fibrillation (AF), at moderate to high risk of stroke, or systemic embolism with at least one additional risk factor (i.e. previous ischemic stroke, TIA, or systemic embolism, left ventricular dysfunction, age >=75 years, age >=65 with either diabetes mellitus, history of coronary artery disease or hypertension)

Exclusion Criteria:

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.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

United States, Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, China, Colombia, Czech Republic, Denmark, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Italy, Japan, Korea, Republic of, Malaysia, Mexico, Netherlands, Norway, Peru, Philippines, Poland, Portugal, Romania, Russian Federation, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Ukraine, United Kingdom

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00262600

Responsible Party

Boehringer Ingelheim, Study Chair, Boehringer Ingelheim

Secondary IDs ^††

2005-003894-26

Study Sponsor ^†

Boehringer Ingelheim Pharmaceuticals

Collaborators ^††

Investigators ^†

Study Chair:

Boehringer Ingelheim

Boehringer Ingelheim Pharmaceuticals

Information Provided By

Boehringer Ingelheim Pharmaceuticals

Verification Date

April 2009

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.