RELY-ABLE Long Term Multi-center Extension of Dabigatran Treatment in Patients With Atrial Fibrillation Who Completed RE-LY Trial - Full Text View

Purpose

The purposes of this study are:

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

Condition	Intervention	Phase
Atrial Fibrillation	Drug: dabigatran dose 1 Drug: dabigatran dose 2	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
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

Resource links provided by NLM:

Genetics Home Reference related topics: familial atrial fibrillation

MedlinePlus related topics: Atrial Fibrillation

Drug Information available for: Dabigatran Dabigatran etexilate Dabigatran etexilate mesylate

U.S. FDA Resources

Further study details as provided by Boehringer Ingelheim Pharmaceuticals:

Primary Outcome Measures:

major bleeding [ Time Frame: up to 28 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

stroke [ Time Frame: up to 28 months ] [ Designated as safety issue: No ]
non CNS systemic embolism [ Time Frame: up to 28 months ] [ Designated as safety issue: No ]
pulmonary embolism [ Time Frame: up to 28 months ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
acute myocardial infarction [ Time Frame: up to 28 months ] [ Designated as safety issue: No ]
deep vein thrombosis [ Time Frame: up to 28 months ] [ Designated as safety issue: No ]
death [ Time Frame: up to 28 months ] [ Designated as safety issue: No ]

Enrollment:	5894
Study Start Date:	November 2008
Study Completion Date:	December 2012
Primary Completion Date:	December 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: dabigatran dose 1 dabigatran high dose twice daily	Drug: dabigatran dose 1 dabigatran high dose twice daily
Experimental: dabigatran dose 2 dabigatran low dose twice daily	Drug: dabigatran dose 2 dabigatran low dose twice daily

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

Show 567 Study Locations

Sponsors and Collaborators

Boehringer Ingelheim Pharmaceuticals

Investigators

Study Chair:

Boehringer Ingelheim

Boehringer Ingelheim Pharmaceuticals

More Information

No publications provided

Responsible Party:	Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00808067 History of Changes
Other Study ID Numbers:	1160.71, 2008-005248-17
Study First Received:	December 12, 2008
Last Updated:	June 12, 2013
Health Authority:	Australia: Dept of Health and Ageing Therapeutic Goods Admin Austria: Medicines and Medical Devices Agency Belgium: Federal Agency for Medicines and Health Products, FAMHP Brazil: National Health Surveillance Agency Bulgaria: Bulgarian Drug Agency, BG-1504 Sofia Canada: Health Canada, Therapeutic Products Directorate China: Food and Drug Administration Czech Republic: State Institute for Drug Control (SUKL), CZ-100 41 Prague 10 Denmark: The Danish Medicines Agency Finland: Finnish Medicines Agency France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) Germany: Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM), Kurt-Georg-Kiesinger-Allee 3, D-53175 Bonn 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: Israeli Health Ministry Pharmaceutical Administration 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) 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 of the Russian Federation Singapore: Health Sciences Authority Slovakia: SUKL (state institute for drug control), SK-825 08 Bratislava 26 Sweden: Medical Products Agency Regional Ethics Committee of Uppsala Switzerland: Swissmedic Taiwan: Department of Health, Executive Yuan, Taiwan Thailand: Thai Food & Drug Administration United States: Food and Drug Administration

Additional relevant MeSH terms:

Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on June 17, 2013