PETRO Stroke Prevention in Patients With AF by Treatment With Dabigatran, With and Without Aspirin, Compared to Warfarin
- Conditions
- Atrial Fibrillation
- Interventions
- Registration Number
- NCT01227629
- Lead Sponsor
- Boehringer Ingelheim
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 502
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description dabigatran 150 mg bid + 81 mg ASA qd dabigatran with ASA Dabigatran: one capsule in the morning and 1 capsule in the evening. ASA in the morning dabigatran 150 mg bid + 325 mg ASA qd dabigatran with ASA Dabigatran: one capsule in the morning and 1 capsule in the evening. ASA in the morning dabigatran 300 mg bid dabigatran without ASA Dabigatran: one capsule in the morning and 1 capsule in the evening dabigatran 50 mg twice daily (bid) dabigatran without ASA Dabigatran: one capsule in the morning and 1 capsule in the evening. Twice daily (bis in die = bid). dabigatran 50 mg bid + 81 mg ASA qd dabigatran with ASA Dabigatran: one capsule in the morning and 1 capsule in the evening. Acetylsalicylic acid (ASA) once daily (quaque dies = qd) in the morning. dabigatran 50 mg bid + 325 mg ASA qd dabigatran with ASA Dabigatran: one capsule in the morning and 1 capsule in the evening. ASA in the morning dabigatran 150 mg bid dabigatran without ASA Dabigatran: one capsule in the morning and 1 capsule in the evening dabigatran 300 mg bid + 81 mg ASA qd dabigatran with ASA Dabigatran: one capsule in the morning and 1 capsule in the evening. ASA in the morning dabigatran 300 mg bid + 325 mg ASA qd dabigatran with ASA Dabigatran: one capsule in the morning and 1 capsule in the evening. ASA in the morning warfarin warfarin once daily, dosed to target International Normalised Ratio (INR) 2.0 to 3.0
- Primary Outcome Measures
Name Time Method Number of Participants With Fatal or Life-threatening Major Bleeding Events 12 weeks 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
Number of Participants With Minor/Relevant Bleeding Events 12 weeks Haematuria, rectal bleeding, gingival bleeding, skin hematoma of 25cm\^2 or more, nose bleed of more than 5 minutes duration, bleeding leading to a hospitalization, leading to a transfusion of less than 2 units or any other clinically relevant bleeding
Number of Participants With Minor/Nuisance Bleeding Events 12 weeks All bleeding events not fulfilling one of the criteria for major bleeding event or minor/relevant bleeding events.
- Secondary Outcome Measures
Name Time Method Number of Participants With Thromboembolic Events: Composite Endpoint 12 weeks Combination of ischemic stroke (fatal or non fatal), transient ischemic attack, systemic thromboembolism, myocardial infarction (fatal or non fatal), other major adverse cardiac event and all cause mortality
Thromboembolic Events: Number of Participants With Transient Ischemic Attack 12 weeks Occurence of a transient ischemic attack
Number of Participants With Thromboembolic Events: Ischemic Stroke 12 weeks Occurence of an ischemic stroke (fatal or non-fatal)
Thromboembolic Events: Number of Participants With Systemic Thromboembolism 12 weeks Occurence of a systemic thromboembolism
Thromboembolic Events: Number of Participants With Myocardial Infarction 12 weeks Occurence of a myocardial infarction
Thromboembolic Events: Number of Participants With Other Major Cardiac Events 12 weeks Occurence of other major adverse cardiac events
Thromboembolic Events: Number of Participants Who Died 12 weeks Occurence of death by all causes
D-dimer: Difference From Baseline baseline and 12 weeks Difference in D-dimer from baseline to last available value
Soluble Fibrin: Difference From Baseline baseline and 12 weeks Difference from baseline to visit 7
11-dehydrothromboxane B2 (TXB2): Difference From Baseline baseline and 12 weeks Difference from baseline to visit 7
Ecarin Clotting Time (ECT): Difference From Baseline baseline and 12 weeks Activated Partial Thromboplastin Time (aPTT): Difference From Baseline baseline and 12 weeks Trough Plasma Concentration of Dabigatran (BIBR 953) 12 weeks The values of the trough plasma concentration of dabigatran (BIBR 953) are the by-patient geometric means of week 1, 4 and 12.
Number of Participants With Increase of Aspartat-Aminotransferase (AST) to >2*Baseline 12 weeks Increase of AST to more than two times the baseline value
Number of Participants With Increase of Alkaline Phosphatase (AP) to >2*Baseline 12 weeks Increase of AP to more than two times the baseline value
Number of Participants With Increase of Bilirubin to >2*Baseline 12 weeks Increase of Bilirubin to more than two times the baseline value
Number of Participants With Increase of Alanine-Aminotransferase (ALT) to >2*Baseline 12 weeks Number of Participants with Increase of ALT to more than two times the baseline value
Severity of Adverse Events 12 weeks Total number of patients with any adverse event of worst intensity 'mild', 'moderate' and 'severe'.
Trial Locations
- Locations (38)
1160.20.10015
🇺🇸Baltimore, Maryland, United States
1160.20.45010
🇩🇰Aalborg, Denmark
1160.20.45005 Aarhus Sygehus
🇩🇰Aarhus C, Denmark
1160.20.45007 Medicinsk afdeling
🇩🇰Brædstrup, Denmark
1160.20.45012 Afdeling B3
🇩🇰Frederikssund, Denmark
1160.20.45009 Medicinsk amb. B8
🇩🇰Holbæk, Denmark
1160.20.45002 Kardiologisk afdeling
🇩🇰Hvidovre, Denmark
1160.20.45001 Kardiologisk Laboratorium
🇩🇰Odense, Denmark
1160.20.45013 Kardiologisk afd.
🇩🇰Roskilde, Denmark
1160.20.45006 Medicinsk afdeling
🇩🇰Svendborg, Denmark
1160.20.45014 Hjertemedicinsk afd.
🇩🇰Køge, Denmark
1160.20.46003 Centrallasarettet
🇸🇪Västerås, Sweden
1160.20.46008 Vrinnevisjukhuset
🇸🇪Norrköping, Sweden
1160.20.10009
🇺🇸North Durham, North Carolina, United States
1160.20.46013 HIA, Mälarsjukhuset
🇸🇪Eskilstuna, Sweden
1160.20.45004 Herlev Hospital
🇩🇰Herlev, Denmark
1160.20.46007 Falu Lasarett
🇸🇪Falun, Sweden
1160.20.46002 Södersjukhuset
🇸🇪Stockholm, Sweden
1160.20.46004 Universitetssjukhuset
🇸🇪Örebro, Sweden
1160.20.10010
🇺🇸Fayetteville, Arkansas, United States
1160.20.10003 La Mesa Cardiac
🇺🇸La Mesa, California, United States
1160.20.10006 The Ford Research Institute, PA
🇺🇸Pensacola, Florida, United States
1160.20.10002
🇺🇸St. Petersburg, Florida, United States
1160.20.10008
🇺🇸Westminister, Maryland, United States
1160.20.10012
🇺🇸Pittsfield, Massachusetts, United States
1160.20.10007
🇺🇸Troy, Michigan, United States
1160.20.10005
🇺🇸Germantown, Tennessee, United States
1160.20.10001
🇺🇸Philadelphia, Pennsylvania, United States
1160.20.45011 Medicinsk afd.
🇩🇰Esbjerg, Denmark
1160.20.45003 Forskningscentret plan 3
🇩🇰Helsingør, Denmark
1160.20.46010 Länssjukhuset Kalmar
🇸🇪Kalmar, Sweden
1160.20.46005 Ryhovs Länssjukhus
🇸🇪Jönköping, Sweden
1160.20.46009 Universitetssjukhuset MAS
🇸🇪Malmö, Sweden
1160.20.46011 Arytmienheten, Med klin
🇸🇪Stockholm, Sweden
1160.20.46006 Norrlands Universitetssjukhus
🇸🇪Umeå, Sweden
1160.20.10004
🇺🇸Port Charlotte, Florida, United States
1160.20.10013
🇺🇸New Hyde Park, New York, United States
1160.20.10014
🇺🇸Hawthorne, New York, United States