Randomized, Open Label Study of Dabigatran Etexilate in Elective Percutaneous Coronary Intervention

Phase 2 Completed 53 enrolled Boehringer Ingelheim

RandomizedParallel-groupOpen-labelTreatment

Summary

To assess whether two doses of dabigatran etexilate (110 mg twice daily (b.i.d) and 150 mg twice daily (b.i.d)) as compared to unfractionated heparin (UFH), both in addition to a standard dual antiplatelet regimen, provide sufficient anticoagulation in the setting of elective percutaneous coronary intervention (PCI).

Timeline

Start: 2009-01
Primary completion: 2010-08
Completion: —

Publications

Vranckx P, Verheugt FW, de Maat MP, Ulmans VA, Regar E, Smits P, ten Berg JM, Lindeboom W, Jones RL, Friedman J, Reilly P, Leebeek FW. A randomised study of dabigatran in elective percutaneous coronary intervention in stable coronary artery disease patients. EuroIntervention. 2013 Jan 22;8(9):1052-60. doi: 10.4244/EIJV8I9A162.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Dabigatran	Unknown	110 mg	—
Subject	Dabigatran	Unknown	150 mg	—
Comparator	Heparin	Other / unclassified	—	—

Indications

No indication recorded.