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RELY-ABLE Long Term Multi-Center Extension of Dabigatran Treatment in Patients With Atrial Fibrillation Who Completed RE-LY Trial
This study is currently recruiting participants.
Verified by Boehringer Ingelheim Pharmaceuticals, December 2008
Sponsored by: Boehringer Ingelheim Pharmaceuticals
Information provided by: Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00808067
  Purpose

The purposes of this study are:

  1. To evaluate the long-term safety of dabigatran etexilate
  2. To assess the effect of a knowledge translation intervention on patient outcomes

Condition Intervention Phase
Atrial Fibrillation
 Drug: dabigatran etexilate
 Phase III

Genetics Home Reference related topics: Brugada syndrome familial atrial fibrillation short QT syndrome
Drug Information available for: Dabigatran etexilate Dabigatran
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Parallel Assignment, Safety Study
Official Title: RELY-ABLE Long Term Multi-Center Extension of Dabigatran Treatment in Patients With Atrial Fibrillation Who Completed the RE-LY Trial and a Cluster Randomised Trial to Assess the Effect of a Knowledge Translation Intervention on Patient Outcomes

Further study details as provided by Boehringer Ingelheim Pharmaceuticals:

Primary Outcome Measures:
  • Since the objective of this trial is safety, there are no primary efficacy endpoints. Safety will primarily be determined by the occurence of major bleeding. [ Time Frame: up to 28 months ]

Secondary Outcome Measures:
  • The secondary endpoint is the individual and composite incidence of stroke, non CNS systemic embolism, pulmonary embolism, acute myocardial infarction, deep vein thrombosis and all deaths. [ Time Frame: up to 28 months ]

Estimated Enrollment: 8000
Study Start Date: December 2008
Estimated Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
dab1/dab2: Experimental Drug: dabigatran etexilate

  Eligibility

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

Inclusion Criteria:

Participation in RE-LY, requires long term anticoagulation, provides written informed consent

Exclusion Criteria:

Permanent discontinuation of dabigatran during RE-LY

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00808067

Contacts
Contact: Boehringer Ingelheim Study Coordinator 800-542-6257 ext Option 4 clintriage.rdg@boehringer-ingelheim.com

  Show 503 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: 1160.71, 2008-005248-17
Study First Received: December 12, 2008
Last Updated: December 16, 2008
ClinicalTrials.gov Identifier: NCT00808067  
Health Authority: Argentina: A.N.M.A.T. (National Administration of Medications, Food and Medical Technology);   Australia: Responsilble Ethics Committee / Therapeutic Goods Administration;   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, Therapeutic Products Directorate;   China: State Food and Drug Administration;   Colombia: National Institute of Medications and Food Vigilance;   Czech Republic: State Institute for Drug Control (SUKL), CZ-100 41 Prague 10;   Denmark: The Danish Medicines Agency;   Finland: National Agency for Medicines;   France: Afssaps - French Health Products Safety Agency;   Germany: Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM);   Great Britain: MHRA;   Greece: National Organization fo Medicines (EOF) National Ethics Committe;   Hong Kong: Department of Health;   Hungary: National Institute of Pharmacy (OGYI), H-1051 Budapest;   India: Drug Control General of India;   Israel: Ministry of Health;   Italy: Ethics Committee;   Korea, Republic of: Korea Food and Drug Administration (KFDA);   Malaysia: Drug Control Authority;   Netherlands: 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 I.P.;   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;   Sweden: Medical Products Agency;   Sweden: Regional Ethics Committee of Uppsala;   Switzerland: Swissmedic;   Taiwan: Department of Health, Executive Yuan, Taiwan;   Thailand: Thai Food & Drug Administration;   Ukraine: Ministry of Health Crae of Ukraine (MoH of Ukraine);   United States: Food and Drug Administration

Study placed in the following topic categories:
Heart Diseases
Atrial Fibrillation
Arrhythmias, Cardiac

Additional relevant MeSH terms:
Pathologic Processes
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 14, 2009



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