passages: 1620
passages: document
passages: Rationale and design of RE-LY : randomized evaluation of long-term anticoagulant therapy , warfarin , compared with dabigatran . Vitamin K antagonists ( VKAs ) are effective for stroke prevention in patients with atrial fibrillation ( AF ) but are difficult to use . Dabigatran etexilate is a prodrug that is rapidly converted to the active direct thrombin inhibitor dabigatran . It is administered in a fixed dose without laboratory monitoring and is being compared with warfarin ( international normalized ratio 2-3 ) in the RE-LY trial . Two doses of dabigatran ( 110 and 150 mg BID ) are being evaluated . RE-LY is a phase 3 , prospective , randomized , open-label multinational ( 44 countries ) trial of patients with nonvalvular AF and at least 1 risk factor for stroke . Recruitment concluded with a total of 18,113 patients . Patients who were VKA-naive and experienced are included in balanced proportions . The primary outcome is stroke ( including hemorrhagic ) or systemic embolism . Safety outcomes are bleeding , liver function abnormalities , and other adverse events . Adjudication of end points is blinded to drug assignment . The trial is expected to accrue a minimum of 450 events with a minimum 1-year of follow-up . RE-LY is the largest AF stroke prevention trial yet undertaken . It is unique because it includes equal numbers of VKA-experienced and naive patients and evaluates 2 different dosages of dabigatran , which may allow tailoring of dosing to individual patient needs . The worldwide site distribution and broad range of stroke risk further increase the general applicability of the trial . Results are expected in 2009 .
entities: 1621
entities: Intervention_Pharmacological
entities: warfarin
entities: 1622
entities: Intervention_Pharmacological
entities: dabigatran .
entities: 1623
entities: Intervention_Pharmacological
entities: Dabigatran etexilate
entities: 1624
entities: Intervention_Pharmacological
entities: dabigatran .
entities: 1625
entities: Intervention_Pharmacological
entities: warfarin
entities: 1626
entities: Intervention_Pharmacological
entities: dabigatran
entities: 1627
entities: Intervention_Pharmacological
entities: dabigatran
entities: 1628
entities: Outcome_Physical
entities: stroke ( including hemorrhagic )
entities: 1629
entities: Outcome_Physical
entities: systemic embolism
entities: 1630
entities: Outcome_Adverse-effects
entities: bleeding
entities: 1631
entities: Outcome_Adverse-effects
entities: liver function abnormalities
entities: 1632
entities: Outcome_Adverse-effects
entities: other adverse events
entities: 1633
entities: Participant_Condition
entities: atrial fibrillation
entities: 1634
entities: Participant_Condition
entities: AF
entities: 1635
entities: Participant_Sample-size
entities: 18,113