PETRO Stroke Prevention in Patients With AF by Treatment With Dabigatran, With and Without Aspirin, Compared to Warfarin
NCT01227629 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 502
Last updated 2014-05-05
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.
Conditions
Interventions
- DRUG
-
dabigatran with ASA
dose comparison in combination
- DRUG
-
dabigatran with ASA
dose comparison in combination
- DRUG
-
dabigatran with ASA
dose comparison in combination
- DRUG
-
dabigatran with ASA
dose comparison in combination
- DRUG
-
dabigatran with ASA
dose comparison in combination
- DRUG
-
dabigatran with ASA
dose comparison in combination
- DRUG
-
warfarin
comparator
- DRUG
-
dabigatran without ASA
dose comparison
- DRUG
-
dabigatran without ASA
dose comparison
- DRUG
-
dabigatran without ASA
dose comparison
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Boehringer Ingelheim · Boehringer Ingelheim
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2003-09-30
- Primary Completion
- 2004-11-30
Countries
- United States
- Denmark
- Sweden
Study Locations
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