Landmark Research Studies
completed

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 endpoint:

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.

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Study Type

Interventional - Drug

Study Design

RCT parallel group

NO. of Countries

32

NO. of Sites

158

NO. of Participants

7021

Study Period

2006-2011

Sponsor

PHRI

Sanofi

CANNeCTIN

PHRI grant

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