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NCT00621855 · ClinicalTrials.gov registry record · Phase 2
RE-DEEM Dose Finding Study for Dabigatran Etexilate in Patients With Acute Coronary Syndrome
A Phase 2 study, sponsored by Boehringer Ingelheim.
- Completed
- Registry status
- Phase 2
- Development phase
- 1,878
- Enrollment target
NCT00621855: Completed Phase 2 study, sponsored by Boehringer Ingelheim.
NCT00621855 is a Phase 2 study that has completed, run by Boehringer Ingelheim. The registered enrollment target is 1,878 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (1312% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00621855, a Phase 2 study, has completed, sponsored by Boehringer Ingelheim.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 1,878 participants
- Enrollment target
Study 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 addition to dual antiplatelet treatment in patients with an index event (MI) at high risk for new ischaemic cardiovascular events.
Primary Outcome
International Society Thrombosis and Haemostasis (ISTH) definition of a major bleed, and clinically relevant minor bleed. A bleeding event was considered as major if it was fatal, was a symptomatic bleeding in a critical area or organ (intracranial, intraspinal, intraocular, retroperitoneal, intra-articular, pericardial, or intramuscular with compartment syndrome), or caused a fall in haemoglobin level of ≥2 g/dL (≥1.24 mmol/L), or led to transfusion of ≥2 units of whole blood or red cells. Al
Interventions
- DRUG placebo
- DRUG dabigatran etexilate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,878 participants |
| Start Date | 2008-03 |
| Phase | Phase 2 |
What the finished NCT00621855 record still lists
NCT00621855 is an interventional study that assigns participants to a tested intervention. Its 1,878 participants enrollment target places it among the larger protocols in the corpus, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (1312% higher).
The record links to 0 conditions, and to 2 interventions - of which placebo is the first listed.
NCT00621855 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00621855 about?
NCT00621855 is a clinical study titled "RE-DEEM Dose Finding Study for Dabigatran Etexilate in Patients With Acute Coronary Syndrome". 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 i...
What is the current status of trial NCT00621855?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 1,878 participants. The study started on 2008-03.
What interventions are being tested in trial NCT00621855?
The interventions under investigation include: placebo (DRUG), dabigatran etexilate (DRUG).
Who is sponsoring clinical trial NCT00621855?
This trial is sponsored by Boehringer Ingelheim, which has 515 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00621855's enrollment target sits among peer trials
1,878 10th of 2000 higher than 1,991 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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