Status:
COMPLETED
Randomized, Open Label Study of Dabigatran Etexilate in Elective Percutaneous Coronary Intervention
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Heart Catheterization
Eligibility:
All Genders
18-85 years
Phase:
PHASE2
Brief 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 antipla...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
53 Patients enrolled
Trial Details
Trial ID
NCT00818753
Start Date
January 1 2009
Last Update
June 9 2014
Active Locations (4)
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1
1160.73.31004 Boehringer Ingelheim Investigational Site
Alkmaar, Netherlands
2
1160.73.31003 Boehringer Ingelheim Investigational Site
Nieuwegein, Netherlands
3
1160.73.1 Boehringer Ingelheim Investigational Site
Rotterdam, Netherlands
4
1160.73.31002 Boehringer Ingelheim Investigational Site
Rotterdam, Netherlands