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Randomized Evaluation of Long Term Anticoagulant Therapy (RE-LY) With Dabigatran Etexilate
This study has been completed.
First Received: December 6, 2005   Last Updated: May 25, 2009   History of Changes
Sponsor: Boehringer Ingelheim Pharmaceuticals
Information provided by: Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00262600
  Purpose

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.


Condition Intervention Phase
Atrial Fibrillation
Cerebrovascular Accident
Drug: Dabigatran etex
Drug: Warfarin
Phase III

Study Type: Interventional
Study Design: Prevention, Parallel Assignment, Safety/Efficacy Study
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)

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim Pharmaceuticals:

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

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 ]

Enrollment: 18113
Study Start Date: November 2005
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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:

  1. 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
  2. Severe, disabling stroke within the previous 6 months, or any stroke within the previous 14 days
  3. Conditions associated with an increased risk of bleeding
  4. Contraindication to warfarin treatment
  5. Reversible causes of atrial fibrillation (e.g., cardiac surgery, pulmonary embolism, untreated hyperthyroidism).
  6. Plan to perform a pulmonary vein ablation or surgery for cure of the AF
  7. Severe renal impairment (estimated creatinine clearance <=30 mL/min)
  8. Active infective endocarditis
  9. Active liver disease
  10. Women who are pregnant, lactating, or of childbearing potential who refuse to use a medically acceptable form of contraception throughout the study
  11. Anaemia (haemoglobin <100g/L) or thrombocytopenia (platelet count <100 x 109/L)
  12. Patients who have developed transaminase elevations upon exposure to ximelagatran
  13. Patients who have received an investigational drug in the past 30 days or are participating in another drug study
  14. 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)
  15. Any known hypersensitivity to galactose if the warfarin used contains galactose.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00262600

  Show 953 Study Locations
Sponsors and Collaborators
Boehringer Ingelheim Pharmaceuticals
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim Pharmaceuticals
  More Information

No publications provided by Boehringer Ingelheim Pharmaceuticals

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):
Responsible Party: Boehringer Ingelheim ( Boehringer Ingelheim, Study Chair )
Study ID Numbers: 1160.26, 2005-003894-26
Study First Received: December 6, 2005
Last Updated: May 25, 2009
ClinicalTrials.gov Identifier: NCT00262600     History of Changes
Health Authority: Argentina: A.N.M.A.T. (Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica);   Australia: Responsilble Ethics Committee;   Austria: Federal Office for Safety in Health Care;   Belgium: Federal Agency for Medicines and Health Products;   Brazil: National Health Surveillance Agency;   Bulgaria: Bulgarian Drug Agency, BG-1504 Sofia;   Canada: Health Canada;   China: State Food and Drug Administration;   Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos;   Czech Republic: State Institute for Drug Control (SUKL), CZ-100 41 Prague 10;   Denmark: Danish Medicines Agency;   Finland: National Agency for Medicines;   France: AFFSAPS;   Germany: Federal Institute for Drugs and Medical Devices;   Great Britain: MHRA;   Greece: National Organization for Medicines (EOF) National Ethics Committee;   Hong Kong: Department of Health;   Hungary: National Institute of Pharmacy, H-1051 Budapest;   India: Drug Control General of India;   Israel: Ministry of Health;   Italy: Comitato Etico Indipendente - BOLOGNA;   Japan: Ministry of Health, Labor and Welfare;   Korea, Republic of: KOREA Food and Drug Administration (KFDA);   Malaysia: Drug Control Authority;   Mexico: Federal Commission for Sanitary Risks Protection;   Netherlands: The Central Committee on Research Involving Human Subjects (CCMO);   Norway: Norwegian Medicines Agency (Statens Legemiddelverk);   Peru: General Directorate of Pharmaceuticals, Devices, and Drugs;   Philippines: Bureau of Food and Drug;   Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products;   Portugal: INFARMED - National Authority of Medicines and Health Products, IP;   Romania: National Medicines Agency, Bucharest;   Russia: Ministry of Health and Social Development of the Russian Federation;   Singapore: Health Sciences Authority;   Slovakia: SUKL (state institute for drug control), SK-825 08 Bratislava 26;   South Africa: MCC;   Spain: Agencia Española del Medicamento y Productos Sanitarios;   Sweden: Medical Products Agency;   Switzerland: Swissmedic;   Taiwan: Department of Health, Executive Yuan, Taiwan;   Thailand: Thai Food & Drug Administration;   Turkey: Ministry of Health Central Ethics Committee;   Ukraine: Ministry of Health Care of Ukraine (MoH of Ukraine);   United States: Food and Drug Administration

Additional relevant MeSH terms:
Anticoagulants
Heart Diseases
Cerebral Infarction
Hematologic Agents
Stroke
Nervous System Diseases
Vascular Diseases
Central Nervous System Diseases
Warfarin
Brain Diseases
Cerebrovascular Disorders
Pharmacologic Actions
Pathologic Processes
Therapeutic Uses
Brain Ischemia
Cardiovascular Diseases
Atrial Fibrillation
Brain Infarction
Arrhythmias, Cardiac

ClinicalTrials.gov processed this record on November 09, 2009