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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT00808067
• Date of registration: 12/12/2008
• Prospective Registration: No
• Primary sponsor: Boehringer Ingelheim
• Public title: RELY-ABLE Long Term Multi-center Extension of Dabigatran Treatment in Patients With Atrial Fibrillation Who Completed RE-LY Trial
• Scientific 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
• Date of first enrolment: November 2008
• Target sample size: 5897
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00808067
• Study type: Interventional
• Phase: Phase 3

Countries of recruitment

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, Ukraine, United Kingdom, United States

Contacts

• Name: Boehringer Ingelheim
• Affiliation: Boehringer Ingelheim

Key inclusion & exclusion criteria

Inclusion criteria:

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

Exclusion criteria:

Permanent discontinuation of dabigatran during RE-LY



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Atrial Fibrillation

Intervention(s)

Drug: dabigatran dose 1

Drug: dabigatran dose 2

Primary Outcome(s)

Major Bleeding, Annualized Rate of Subjects With Major Bleeds [Time Frame: up to 43 months]

Secondary Outcome(s)

Death, Annualized Rate of Subject Death [Time Frame: up to 43 months]

Non CNS Systemic Embolism (SEE), Annualized Rate of Subjects With Non-CNS SEE [Time Frame: up to 43 months]

Acute Myocardial Infarction (MI), Annualized Rate of Subjects With MI [Time Frame: up to 43 months]

Annualized Rate of Subjects With Composite Incidence of Stroke, Non CNS Systemic Embolism (SEE), Pulmonary Embolism (PE), Myocardial Infarction (MI), All Cause Death and Major Bleed [Time Frame: up to 43 months]

Annualized Rate of Subjects With Composite Incidence of Stroke, Non CNS Systemic Embolism (SEE), Pulmonary Embolism (PE), Myocardial Infarction, Vascular Death [Time Frame: up to 43 months]

Annualized Rate of Subjects With Intra-Cranial Hemorrhage (ICH) [Time Frame: up to 43 months]

Pulmonary Embolism (PE), Annualized Rate of Subjects With PE [Time Frame: up to 43 months]

Annualized Rate of Subjects With Composite Incidence of Stroke, Non CNS Systemic Embolism (SEE) [Time Frame: up to 43 months]

Annualized Rate of Subjects With Composite Incidence of Stroke, Non CNS Systemic Embolism (SEE) and All Cause Death [Time Frame: up to 43 months]

Stroke, Annualized Rate of Subjects With Stroke [Time Frame: up to 43 months]

Annualized Rate of Subjects With Minor Bleeds [Time Frame: up to 43 months]

Annualized Rate of Subjects With Any Bleeds (Major Plus Minor) [Time Frame: up to 43 months]

Deep Vein Thrombosis, Annualized Rate of Subjects With DVT [Time Frame: up to 43 months]

Secondary ID(s)

1160.71

2008-005248-17

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 08/04/2014
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00808067