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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 is a Phase 2 study that has completed, run by Boehringer Ingelheim. The registered enrollment target is 502 participants.
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.
Interventions
- DRUG dabigatran with ASA
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 502 participants |
| Start Date | 2003-09 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01227629
The ClinicalTrials.gov registry entry for NCT01227629 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 502 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Boehringer Ingelheim, which has 515 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which dabigatran with ASA is the first listed.
NCT01227629 reports 0 study locations.
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.
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