RE-DEEM Dose Finding Study for Dabigatran Etexilate in Patients With Acute Coronary Syndrome
Completed · Phase 2 · Has a placebo group
Conditions studied: Coronary Disease
In brief
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 addition to dual antiplatelet treatment in patients with an index event (MI) at high risk for new ischaemic cardiovascular events.
Key facts
- Study ID
- NCT00621855
- Run by
- Boehringer Ingelheim
- People needed
- 1878
- Starts
- 2008-03-01
- Last updated by the study team
- 2014-03-12
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may not qualify if…
- 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
Where it is running
- 1160.67.32008 Boehringer Ingelheim Investigational Site — Bouge/Namur, Belgium
- 1160.67.32011 Boehringer Ingelheim Investigational Site — Brasschaat, Belgium
- 1160.67.32005 Boehringer Ingelheim Investigational Site — Edegem, Belgium
- 1160.67.32002 Boehringer Ingelheim Investigational Site — Genk, Belgium
- 1160.67.32006 Boehringer Ingelheim Investigational Site — Gilly, Belgium
- 1160.67.32003 Boehringer Ingelheim Investigational Site — Hasselt, Belgium
- 1160.67.32001 Boehringer Ingelheim Investigational Site — Leuven, Belgium
- 1160.67.32004 Boehringer Ingelheim Investigational Site — Tienen, Belgium
- 1160.67.59007 Boehringer Ingelheim Investigational Site — Burgas, Bulgaria
- 1160.67.59009 Boehringer Ingelheim Investigational Site — Dimitrovgrad, Bulgaria
- 1160.67.59003 Boehringer Ingelheim Investigational Site — Pleven, Bulgaria
- 1160.67.59012 Boehringer Ingelheim Investigational Site — Pleven, Bulgaria
- 1160.67.59006 Boehringer Ingelheim Investigational Site — Rousse, Bulgaria
- 1160.67.59001 Boehringer Ingelheim Investigational Site — Sofia, Bulgaria
- 1160.67.59002 Boehringer Ingelheim Investigational Site — Sofia, Bulgaria
- 1160.67.59004 Boehringer Ingelheim Investigational Site — Sofia, Bulgaria
- 1160.67.59005 Boehringer Ingelheim Investigational Site — Sofia, Bulgaria
- 1160.67.59008 Boehringer Ingelheim Investigational Site — Sofia, Bulgaria
- 1160.67.59010 Boehringer Ingelheim Investigational Site — Sofia, Bulgaria
- 1160.67.11009 Boehringer Ingelheim Investigational Site — Calgary, Alberta, Canada
- 1160.67.11003 Boehringer Ingelheim Investigational Site — Vancouver, British Columbia, Canada
- 1160.67.11012 Boehringer Ingelheim Investigational Site — Cambridge, Ontario, Canada
- 1160.67.11010 Boehringer Ingelheim Investigational Site — Greater Sudbury, Ontario, Canada
- 1160.67.11020 Boehringer Ingelheim Investigational Site — Greater Sudbury, Ontario, Canada
- 1160.67.10002 Boehringer Ingelheim Investigational Site — Clearwater, Florida, United States
Full record on ClinicalTrials.gov
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