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Randomized Evaluation of Long Term Anticoagulant Therapy (RE-LY) With Dabigatran Etexilate
This study has been completed.

First Received on December 6, 2005.   Last Updated on July 4, 2011   History of Changes
Sponsor: Boehringer Ingelheim Pharmaceuticals
Collaborators: Population Health Research Institute
Uppsala University
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
Stroke
Drug: warfarin
Drug: Dabigatran dose 1
Drug: Dabigatran dose 2
Phase III

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Prevention
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:
  • Yearly Event Rate for Composite Endpoint of Stroke/SEE [ Time Frame: 36 months ] [ Designated as safety issue: No ]
    Time to first occurrence of stroke or systemic embolic event. Yearly event rate (%) = number of subjects with event / subject-years * 100. Subject years = sum(date of study termination - date of randomization + 1) of all randomized subjects / 365.25


Secondary Outcome Measures:
  • Yearly Event Rate for Composite Endpoint of Stroke/SEE/All Cause Death [ Time Frame: 36 months ] [ Designated as safety issue: No ]
    Time to first occurrence of stroke, SEE or all cause death. Yearly event rate (%) = number of subjects with event / subject-years * 100. Subject years = sum(date of study termination - date of randomization + 1) of all randomized subjects / 365.25

  • Yearly Event Rate: Composite of Stroke/SEE/PE/MI/Vascular Death [ Time Frame: 36 months ] [ Designated as safety issue: No ]
    Time to first occurrence of stroke, systemic embolic event, pulmonary embolism, myocardial infarction or vascular death. Yearly event rate (%) = number of subjects with event / subject-years * 100. Subject years = sum(date of study termination - date of randomization + 1) of all randomized subjects / 365.25


Enrollment: 18113
Study Start Date: November 2005
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Dabigatran dose 2
twice a day
Drug: Dabigatran dose 2
twice a day
Active Comparator: Warfarin
once a day
Drug: warfarin
once a day
Active Comparator: Dabigatran dose 1
twice a day
Drug: Dabigatran dose 1
twice daily

  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 952 Study Locations
Sponsors and Collaborators
Boehringer Ingelheim Pharmaceuticals
Population Health Research Institute
Uppsala University
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim Pharmaceuticals
  More Information

Additional Information:
No publications provided by Boehringer Ingelheim Pharmaceuticals

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Oldgren J, Alings M, Darius H, Diener HC, Eikelboom J, Ezekowitz MD, Kamensky G, Reilly PA, Yang S, Yusuf S, Wallentin L, Connolly SJ; RE-LY Investigators. Risks for stroke, bleeding, and death in patients with atrial fibrillation receiving dabigatran or warfarin in relation to the CHADS2 score: a subgroup analysis of the RE-LY trial. Ann Intern Med. 2011 Nov 15;155(10):660-7, W204.
Eikelboom JW, Wallentin L, Connolly SJ, Ezekowitz M, Healey JS, Oldgren J, Yang S, Alings M, Kaatz S, Hohnloser SH, Diener HC, Franzosi MG, Huber K, Reilly P, Varrone J, Yusuf S. Risk of bleeding with 2 doses of dabigatran compared with warfarin in older and younger patients with atrial fibrillation: an analysis of the randomized evaluation of long-term anticoagulant therapy (RE-LY) trial. Circulation. 2011 May 31;123(21):2363-72. Epub 2011 May 16.
Nagarakanti R, Ezekowitz MD, Oldgren J, Yang S, Chernick M, Aikens TH, Flaker G, Brugada J, Kamensky G, Parekh A, Reilly PA, Yusuf S, Connolly SJ. Dabigatran versus warfarin in patients with atrial fibrillation: an analysis of patients undergoing cardioversion. Circulation. 2011 Jan 18;123(2):131-6. Epub 2011 Jan 3.
Ezekowitz MD, Wallentin L, Connolly SJ, Parekh A, Chernick MR, Pogue J, Aikens TH, Yang S, Reilly PA, Lip GY, Yusuf S; RE-LY Steering Committee and Investigators. Dabigatran and warfarin in vitamin K antagonist-naive and -experienced cohorts with atrial fibrillation. Circulation. 2010 Nov 30;122(22):2246-53.
Diener HC, Connolly SJ, Ezekowitz MD, Wallentin L, Reilly PA, Yang S, Xavier D, Di Pasquale G, Yusuf S; RE-LY study group. Dabigatran compared with warfarin in patients with atrial fibrillation and previous transient ischaemic attack or stroke: a subgroup analysis of the RE-LY trial. Lancet Neurol. 2010 Dec;9(12):1157-63. Epub 2010 Nov 6.
Connolly SJ, Ezekowitz MD, Yusuf S, Eikelboom J, Oldgren J, Parekh A, Pogue J, Reilly PA, Themeles E, Varrone J, Wang S, Alings M, Xavier D, Zhu J, Diaz R, Lewis BS, Darius H, Diener HC, Joyner CD, Wallentin L; RE-LY Steering Committee and Investigators. Dabigatran versus warfarin in patients with atrial fibrillation. N Engl J Med. 2009 Sep 17;361(12):1139-51. Epub 2009 Aug 30.
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.

Responsible Party: Boehringer Ingelheim, Study Chair, Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00262600     History of Changes
Other Study ID Numbers: 1160.26, 2005-003894-26
Study First Received: December 6, 2005
Results First Received: November 18, 2010
Last Updated: July 4, 2011
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: Finnish Medicines Agency;   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:
Atrial Fibrillation
Stroke
Cerebral Infarction
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Brain Infarction
Brain Ischemia
Anticoagulants
Warfarin
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 09, 2012