Oral prodrug – converted to dabigatran
Reversible, direct thrombin inhibitor
Plasma half-life of dabigatran is 14-17 hrs
Once-daily dosing
Renal excretion
Bioavailability only ~4-5%
Re-LY trial (Randomized Evaluation of Long term anticoagulant therapy)
Dabigatran vs warfarin for preventing stroke and systemic embolic events in atrial fibrillation.
The RE-LY trial is comparing oral dabigatran etexilate with warfarin @ INR 2.0-3.0 in patients with non-valvular atrial fibrillation who are at moderate-to-high risk of stroke. Dr. Salim Yusuf is the head of the study coordinating center at McMaster University in Hamilton.
The study has completed enrollment of 18,114 patients, from 1,000 centers, in 44 countries between December 2005 and December 2007. Final study results are expected to be reported in early 2009.