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

Boehringer Ingelheim

Status and phase: Completed; Phase 3

Conditions: Atrial Fibrillation

Treatments: Drug: dabigatran dose 1; Drug: dabigatran dose 2

Study type: Interventional

Funder types: Industry

Identifiers

NCT00808067

1160.71

2008-005248-17 (EudraCT Number)

Details and patient eligibility

About

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

Enrollment: 5,897 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

Permanent discontinuation of dabigatran during RE-LY

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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5,897 participants in 2 patient groups

dabigatran dose 1

Experimental group

Description:

dabigatran high dose twice daily

Treatment:

Drug: dabigatran dose 1

dabigatran dose 2

Experimental group

Description:

dabigatran low dose twice daily

Treatment:

Drug: dabigatran dose 2