Status:
COMPLETED
RE-DEEM Dose Finding Study for Dabigatran Etexilate in Patients With Acute Coronary Syndrome
Lead Sponsor:
Boehringer Ingelheim
Collaborating Sponsors:
Uppsala University
Conditions:
Coronary Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this trial is to evaluate the safety and indicators of efficacy of up to 4 doses of orally administered dabigatran etexilate, administered twice daily, compared to placebo when given in...
Eligibility Criteria
Inclusion
- Inclusion criteria Patients with acute coronary syndromes with at least one additional risk factor for cardiovascular complications.
- Exclusion criteria
- Long term treatment with any other oral anticoagulant
- Severe/disabling stroke within last 6 months
- Conditions associated with increased bleeding risk
- Anaemia or thrombocytopenia
- Severe renal impairment
- Liver disease
- Positive pregnancy test
Exclusion
Key Trial Info
Start Date :
March 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
1878 Patients enrolled
Trial Details
Trial ID
NCT00621855
Start Date
March 1 2008
Last Update
March 12 2014
Active Locations (167)
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1
1160.67.10002 Boehringer Ingelheim Investigational Site
Clearwater, Florida, United States
2
1160.67.32008 Boehringer Ingelheim Investigational Site
Bouge/Namur, Belgium
3
1160.67.32011 Boehringer Ingelheim Investigational Site
Brasschaat, Belgium
4
1160.67.32005 Boehringer Ingelheim Investigational Site
Edegem, Belgium