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

Boehringer Ingelheim

Status and phase: Completed; Phase 2

Conditions: Heart Catheterization

Treatments: Drug: unfractionated heparin; Drug: dabigatran 150 mg; Drug: dabigatran 110 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT00818753

1160.73

2007-007536-25 (EudraCT Number)

Details and patient eligibility

About

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).

Enrollment: 53 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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53 participants in 3 patient groups

Dabigatran 110 mg

Experimental group

Description:

experimental drug therapy in this indication

Treatment:

Drug: dabigatran 110 mg

Dabigatran 150 mg

Experimental group

Description:

experimental drug therapy in this indication

Treatment:

Drug: dabigatran 150 mg

Unfractionated Heparin

Active Comparator group

Description:

standard therapy in this indication as comparator

Treatment:

Drug: unfractionated heparin