RELY-ABLE Long Term Multi-center Extension of Dabigatran Treatment in Patients With Atrial Fibrillation Who Completed RE-LY Trial
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ClinicalTrials.gov Identifier: NCT00808067 |
Recruitment Status
:
Completed
First Posted
: December 15, 2008
Results First Posted
: April 8, 2014
Last Update Posted
: June 9, 2014
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Tracking Information | ||||
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First Submitted Date ICMJE | December 12, 2008 | |||
First Posted Date ICMJE | December 15, 2008 | |||
Results First Submitted Date | December 20, 2013 | |||
Results First Posted Date | April 8, 2014 | |||
Last Update Posted Date | June 9, 2014 | |||
Study Start Date ICMJE | November 2008 | |||
Actual Primary Completion Date | December 2012 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
Major Bleeding, Annualized Rate of Subjects With Major Bleeds [ Time Frame: up to 43 months ] Annualized event rate (%) = 100 * No. subjects with event / subject-years. Subject-years = Sum (date of last visit - date of first dose + 1) of all subjects / 365.25. Major bleeding must have satisfied one or more of the following criteria:
Major bleed were classified as life-threatening if they met one or more of the following criteria:
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Original Primary Outcome Measures ICMJE |
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 ] | |||
Change History | Complete list of historical versions of study NCT00808067 on ClinicalTrials.gov Archive Site | |||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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 ] | |||
Current Other Outcome Measures ICMJE | Not Provided | |||
Original Other Outcome Measures ICMJE | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | RELY-ABLE Long Term Multi-center Extension of Dabigatran Treatment in Patients With Atrial Fibrillation Who Completed RE-LY Trial | |||
Official Title ICMJE | 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 | |||
Brief Summary | The purposes of this study are:
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Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase | Phase 3 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Primary Purpose: Treatment |
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Condition ICMJE | Atrial Fibrillation | |||
Intervention ICMJE |
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Study Arms |
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Publications * | Connolly SJ, Wallentin L, Ezekowitz MD, Eikelboom J, Oldgren J, Reilly PA, Brueckmann M, Pogue J, Alings M, Amerena JV, Avezum A, Baumgartner I, Budaj AJ, Chen JH, Dans AL, Darius H, Di Pasquale G, Ferreira J, Flaker GC, Flather MD, Franzosi MG, Golitsyn SP, Halon DA, Heidbuchel H, Hohnloser SH, Huber K, Jansky P, Kamensky G, Keltai M, Kim SS, Lau CP, Le Heuzey JY, Lewis BS, Liu L, Nanas J, Omar R, Pais P, Pedersen KE, Piegas LS, Raev D, Smith PJ, Talajic M, Tan RS, Tanomsup S, Toivonen L, Vinereanu D, Xavier D, Zhu J, Wang SQ, Duffy CO, Themeles E, Yusuf S. The Long-Term Multicenter Observational Study of Dabigatran Treatment in Patients With Atrial Fibrillation (RELY-ABLE) Study. Circulation. 2013 Jul 16;128(3):237-43. doi: 10.1161/CIRCULATIONAHA.112.001139. Epub 2013 Jun 14. | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
5897 | |||
Original Estimated Enrollment ICMJE |
8000 | |||
Actual Study Completion Date | December 2012 | |||
Actual Primary Completion Date | December 2012 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion criteria: Participation in RE-LY, requires long term anticoagulation, provides written informed consent Exclusion criteria: Permanent discontinuation of dabigatran during RE-LY |
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Sex/Gender |
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Ages | 18 Years and older (Adult, Senior) | |||
Accepts Healthy Volunteers | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Australia, Austria, Belgium, Brazil, Bulgaria, Canada, China, Czech Republic, Denmark, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Israel, Italy, Korea, Republic of, Malaysia, Netherlands, Norway, Philippines, Poland, Portugal, Romania, Russian Federation, Singapore, Slovakia, Sweden, Switzerland, Taiwan, Thailand, United Kingdom, United States | |||
Removed Location Countries | Ukraine | |||
Administrative Information | ||||
NCT Number ICMJE | NCT00808067 | |||
Other Study ID Numbers ICMJE | 1160.71 2008-005248-17 ( EudraCT Number: EudraCT ) |
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Has Data Monitoring Committee | Not Provided | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | Boehringer Ingelheim | |||
Study Sponsor ICMJE | Boehringer Ingelheim | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Boehringer Ingelheim | |||
Verification Date | March 2014 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |