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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Boehringer Ingelheim
• Treatments: Calcium heparin; Dabigatran; Heparin

Criteria

Inclusion criteria:

• patients between 18 and 85 years

• due to undergo elective PCI

• informed consent obtained

Exclusion criteria:

• PCI lesion specific conditions

• class III or IV congestive heart failure

• severe hypertension

• increased bleeding risk

• thrombolytic therapy within 24 hours preceding randomization