Landmark Research Studies
completed

The objective of the RE-LY study was to demonstrate the efficacy and safety of dabigatran etexilate in patients with non-valvular atrial fibrillation for the prevention of stroke and systemic embolism.

Primary endpoint:

Incidence of stroke (including hemorrhagic) and systemic embolism.

Secondary endpointw;

Incidence of stroke (including hemorrhagic); systemic embolism; all death; Incidence of stroke (including hemorrhagic); systemic embolism; pulmonary embolism; acute myocardial infarction; or vascular deaths (including deaths from bleeding).

All primary and secondary events are adjudicated.

RE-LY Presentation - Download PDF
Study Type

Interventional - Drug

Study Design

Prospective, randomized, parallel-group, non-inferiority trial

NO. of Countries

44

NO. of Sites

951

NO. of Participants

18113

Study Period

2005-2009

Sponsor

PHRI

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