NCT00818753

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

The Safety and Pharmacodynamics of Two Doses of Dabigatran Etexilate in Patients Undergoing Cardiac Catheterization

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 53 (actual)
• Sponsor: Boehringer Ingelheim · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Heart Catheterization

Interventions

Type	Name	Description
DRUG	dabigatran 110 mg	comparison of different dabigatran dosages with unfractionated heparin
DRUG	dabigatran 150 mg	comparison of different dabigatran dosages with unfractionated heparin
DRUG	unfractionated heparin	comparison of different dosages dabigatran with unfractionated heparin

Timeline

• Start date: 2009-01-01
• Primary completion: 2010-08-01
• First posted: 2009-01-08
• Last updated: 2014-06-09
• Results posted: 2011-10-25

Locations

4 sites across 1 country: Netherlands