Study 1 of 5951 for search of: United States, North Carolina
Previous Study Return to Search Results Next Study

  Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
Randomized Evaluation of Long Term Anticoagulant Therapy (RE-LY) With Dabigatran Etexilate
This study is ongoing, but not recruiting participants.
Sponsored by: 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 etexilate
Drug: Warfarin
Phase III

Genetics Home Reference related topics: Brugada syndrome familial atrial fibrillation short QT syndrome
MedlinePlus related topics: Blood Thinners
Drug Information available for: Warfarin Warfarin potassium Warfarin sodium Dabigatran etexilate Dabigatran
U.S. FDA Resources
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)

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 ]

Estimated Enrollment: 18000
Study Start Date: November 2005
Estimated Primary Completion Date: March 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 962 Study Locations
Sponsors and Collaborators
Boehringer Ingelheim Pharmaceuticals
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim Pharmaceuticals
  More Information

Responsible Party: Boehringer Ingelheim ( Boehringer Ingelheim, Study Chair )
Study ID Numbers: 1160.26, 2005-003894-26
Study First Received: December 6, 2005
Last Updated: December 10, 2008
ClinicalTrials.gov Identifier: NCT00262600  
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;   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;   Finland: National Agency for Medicines;   France: AFFSAPS;   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;   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;   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;   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

Study placed in the following topic categories:
Heart Diseases
Cerebral Infarction
Stroke
Vascular Diseases
Central Nervous System Diseases
Warfarin
Ischemia
Brain Diseases
Cerebrovascular Disorders
Embolism
Brain Ischemia
Atrial Fibrillation
Brain Infarction
Infarction
Arrhythmias, Cardiac

Additional relevant MeSH terms:
Anticoagulants
Pathologic Processes
Therapeutic Uses
Hematologic Agents
Nervous System Diseases
Cardiovascular Diseases
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009