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NCT01227629 · ClinicalTrials.gov registry record · Phase 2
PETRO Stroke Prevention in Patients With AF by Treatment With Dabigatran, With and Without Aspirin, Compared to Warfarin
A Phase 2 study, sponsored by Boehringer Ingelheim.
- Completed
- Registry status
- Phase 2
- Development phase
- 502
- Enrollment target
NCT01227629: Completed Phase 2 study, sponsored by Boehringer Ingelheim.
NCT01227629 is a Phase 2 study that has completed, run by Boehringer Ingelheim. The registered enrollment target is 502 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (277% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01227629, a Phase 2 study, has completed, sponsored by Boehringer Ingelheim.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 502 participants
- Enrollment target
Study Summary
The purpose of this trial is to evaluate the safety of different doses of BIBR 1048, alone or in combination with acetylsalicylic acid (ASA), as determined by the rates of bleeding and other adverse events. A secondary objective of this trial is to evaluate the anticoagulant effect of different doses of BIBR 1048, based on the reduction of plasma concentrations of D-dimer, a laboratory marker for activated coagulation in patients with atrial fibrillation (AF), and to correlate bleeding and other events with pharmacokinetic (PK) and pharmacodynamic (PD) data.
Primary Outcome
Retroperitoneal, intracranial, intraocular, or intraspinal bleeding, or requiring surgical treatment, or leading to a transfusion of 2 units or more, or leading to a fall in hemoglobin of 20g/L or more
Interventions
- DRUG dabigatran with ASA
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 502 participants |
| Start Date | 2003-09 |
| Phase | Phase 2 |
What the finished NCT01227629 record still lists
NCT01227629 is an interventional study that assigns participants to a tested intervention. The registered 502 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (277% higher).
The record links to 0 conditions, and to 1 intervention - of which dabigatran with ASA is the first listed.
NCT01227629 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01227629 about?
NCT01227629 is a clinical study titled "PETRO Stroke Prevention in Patients With AF by Treatment With Dabigatran, With and Without Aspirin, Compared to Warfarin". The purpose of this trial is to evaluate the safety of different doses of BIBR 1048, alone or in combination with acetylsalicylic acid (ASA), as determined by the rates of bleeding and other adverse events. A secondary objective of this trial is to evaluate the anticoagulant effect of different dos...
What is the current status of trial NCT01227629?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 502 participants. The study started on 2003-09.
What interventions are being tested in trial NCT01227629?
The interventions under investigation include: dabigatran with ASA (DRUG).
Who is sponsoring clinical trial NCT01227629?
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 NCT01227629's enrollment target sits among peer trials
502 69th of 2000 higher than 1,931 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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