PETRO Stroke Prevention in Patients With AF by Treatment... | NCT01227629 | Trialant
NCT01227629
Sponsor
Boehringer Ingelheim
Status
Completed
Last Update Posted
May 5, 2014Estimated
Enrollment
502Actual
Phase
Phase 2
Conditions
Atrial Fibrillation
Interventions
dabigatran with ASA
dabigatran with ASA
dabigatran with ASA
dabigatran with ASA
dabigatran with ASA
dabigatran with ASA
warfarin
dabigatran without ASA
dabigatran without ASA
dabigatran without ASA
Countries
United States
Denmark
Sweden
Protocol Section
Identification Module
NCT ID
NCT01227629
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
1160.20
Secondary IDs
ID
Type
Description
Link
PETRO trial
Other Identifier
OTHER
Brief Title
PETRO Stroke Prevention in Patients With AF by Treatment With Dabigatran, With and Without Aspirin, Compared to Warfarin
Official Title
Dose Exploration in Patients With Atrial Fibrillation
Acronym
Not provided
Organization
Boehringer IngelheimINDUSTRY
Status Module
Record Verification Date
Apr 2014
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Sep 2003
Primary Completion Date
Nov 2004Actual
Completion Date
Not provided
First Submitted Date
Oct 22, 2010
First Submission Date that Met QC Criteria
Oct 22, 2010
First Posted Date
Oct 25, 2010Estimated
Results Waived
Not provided
Results First Submitted Date
Nov 18, 2010
Results First Submitted that Met QC Criteria
Jan 14, 2011
Results First Posted Date
Feb 10, 2011Estimated
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Apr 22, 2014
Last Update Posted Date
May 5, 2014Estimated
Sponsor/Collaborators Module
Responsible Party, by Official Title
Not provided
Lead Sponsor
Boehringer IngelheimINDUSTRY
Collaborators
Not provided
Oversight Module
No data available
No data is available for this block.
Description Module
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 provided
Conditions Module
Conditions
Atrial Fibrillation
Keywords
Not provided
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
502Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
dabigatran 50 mg twice daily (bid)
Experimental
Dabigatran: one capsule in the morning and 1 capsule in the evening. Twice daily (bis in die = bid).
Drug: dabigatran without ASA
dabigatran 50 mg bid + 81 mg ASA qd
Experimental
Dabigatran: one capsule in the morning and 1 capsule in the evening. Acetylsalicylic acid (ASA) once daily (quaque dies = qd) in the morning.
Drug: dabigatran with ASA
dabigatran 50 mg bid + 325 mg ASA qd
Experimental
Dabigatran: one capsule in the morning and 1 capsule in the evening. ASA in the morning
Drug: dabigatran with ASA
dabigatran 150 mg bid
Experimental
Dabigatran: one capsule in the morning and 1 capsule in the evening
Drug: dabigatran without ASA
dabigatran 150 mg bid + 81 mg ASA qd
Experimental
Dabigatran: one capsule in the morning and 1 capsule in the evening. ASA in the morning
Drug: dabigatran with ASA
dabigatran 150 mg bid + 325 mg ASA qd
Interventions
Name
Type
Description
Arm Group Labels
Other Names
dabigatran with ASA
Drug
dose comparison in combination
dabigatran 50 mg bid + 81 mg ASA qd
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Number of Participants With Fatal or Life-threatening Major Bleeding Events
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
12 weeks
Number of Participants With Minor/Relevant Bleeding Events
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
12 weeks
Number of Participants With Minor/Nuisance Bleeding Events
All bleeding events not fulfilling one of the criteria for major bleeding event or minor/relevant bleeding events.
12 weeks
Secondary Outcomes
Measure
Description
Time Frame
Number of Participants With Thromboembolic Events: Composite Endpoint
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
12 weeks
Number of Participants With Thromboembolic Events: Ischemic Stroke
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion criteria
Non-rheumatic atrial fibrillation.
Coronary artery disease (CAD), documented by previous myocard infarction (MI), angina, positive stress test, previous coronary intervention or bypass surgery, or atherosclerotic lesion(s) diagnosed by coronary angiography) is only considered as one of several possible qualifying risk factors. After recruitment of ca. 30%, a protocol amendment 4 was issued so that CAD was only considered as one of several possible qualifying risk factors, 2. see (3 f) below.
An additional risk factor for stroke, i.e. one or more of the following conditions/events:
hypertension (defined as systolic bloodpressure (SBP) > 140 mmHg and/or diastolic bloodpressure (DBP) > 90 mm Hg) requiring antihypertensive medical treatment.
diabetes mellitus (type I and II).
symptomatic heart failure or left ventricular dysfunction (ejection fraction (EF) < 40%).
a previous ischemic stroke or transient ischemic attack.
age greater than 75 years.
history of coronary artery disease (by amendment 4)
Treatment with warfarin or other vitamin K dependent anticoagulants for at least 8 weeks prior to inclusion. International normalised ratio (INR) should be within therapeutic range (i.e. INR 2.0 - 3.0) at visit 1 otherwise the visit should be rescheduled.
Age > = 18 years at entry.
Written, informed consent.
Exclusion criteria
Valvular heart disease.
Planned cardioversion.
Recent (=< 1 month) myocardial infarction, stroke or transient ischemic attack (TIA), or patients who have received a coronary stent within the last 6 months.
Intolerance or contraindications to acetylsalicylic acid (ASA).
Any contraindication to anticoagulant therapy.
Major bleeding within the last 6 months (other than gastrointestinal (GI) hemorrhage).
Abnormal liver function as defined by aspartat-aminotransferase (AST), alanin-aminotransferase (ALT), serum bilirubin or alkaline phosphatase (AP) above the reference range, or history of liver disease.
Women who are pregnant or of childbearing potential who refuses to use a medically acceptable form of contraception throughout the study.
Patients who have received an investigational drug within the last 30 days.
Patients scheduled for major surgery or invasive procedures which may cause bleeding, or those who have had major surgery or percutaneous coronary intervention (PCI) within 6 weeks.
Patients considered unreliable by the investigator.
Another indication for anticoagulant treatment.
Patients suffering from anemia.
Patients suffering from thrombocytopenia.
Any other condition which, in the discretion of the investigator, would not allow safe participation in the study.
Concomitant treatment with antiplatelet agents other than ASA.
Recent malignancy or radiation therapy (=< 6 month).
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
Not provided
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Boehringer Ingelheim
Boehringer Ingelheim
Study Chair
Locations
Facility
Status
City
State
ZIP
Country
Contacts
1160.20.10010
Fayetteville
Arkansas
United States
1160.20.10003 La Mesa Cardiac
References Module
No data available
No data is available for this block.
IPD Sharing Statement Module
No data available
No data is available for this block.
Results Section
Participant Flow Module
Pre-assignment Details
Not provided
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
BIBR 1048 50 mg b.i.d
bid (twice daily) oral
FG001
BIBR 1048 50 mg b.i.d + ASA 81 mg q.d.
bid (twice daily) oral + qd (once daily) oral
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
No data available
No data is available for this block.
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Prevention
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
No data available
No data is available for this block.
Experimental
Dabigatran: one capsule in the morning and 1 capsule in the evening. ASA in the morning
Drug: dabigatran with ASA
dabigatran 300 mg bid
Experimental
Dabigatran: one capsule in the morning and 1 capsule in the evening
Drug: dabigatran without ASA
dabigatran 300 mg bid + 81 mg ASA qd
Experimental
Dabigatran: one capsule in the morning and 1 capsule in the evening. ASA in the morning
Drug: dabigatran with ASA
dabigatran 300 mg bid + 325 mg ASA qd
Experimental
Dabigatran: one capsule in the morning and 1 capsule in the evening. ASA in the morning
Drug: dabigatran with ASA
warfarin
Active Comparator
once daily, dosed to target International Normalised Ratio (INR) 2.0 to 3.0
Drug: warfarin
dabigatran with ASA
Drug
dose comparison in combination
dabigatran 50 mg bid + 325 mg ASA qd
dabigatran with ASA
Drug
dose comparison in combination
dabigatran 150 mg bid + 81 mg ASA qd
dabigatran with ASA
Drug
dose comparison in combination
dabigatran 150 mg bid + 325 mg ASA qd
dabigatran with ASA
Drug
dose comparison in combination
dabigatran 300 mg bid + 81 mg ASA qd
dabigatran with ASA
Drug
dose comparison in combination
dabigatran 300 mg bid + 325 mg ASA qd
warfarin
Drug
comparator
warfarin
dabigatran without ASA
Drug
dose comparison
dabigatran 50 mg twice daily (bid)
dabigatran without ASA
Drug
dose comparison
dabigatran 150 mg bid
dabigatran without ASA
Drug
dose comparison
dabigatran 300 mg bid
Occurence of an ischemic stroke (fatal or non-fatal)
12 weeks
Thromboembolic Events: Number of Participants With Transient Ischemic Attack
Occurence of a transient ischemic attack
12 weeks
Thromboembolic Events: Number of Participants With Systemic Thromboembolism
Occurence of a systemic thromboembolism
12 weeks
Thromboembolic Events: Number of Participants With Myocardial Infarction
Occurence of a myocardial infarction
12 weeks
Thromboembolic Events: Number of Participants With Other Major Cardiac Events
Occurence of other major adverse cardiac events
12 weeks
Thromboembolic Events: Number of Participants Who Died
Occurence of death by all causes
12 weeks
D-dimer: Difference From Baseline
Difference in D-dimer from baseline to last available value
baseline and 12 weeks
Soluble Fibrin: Difference From Baseline
Difference from baseline to visit 7
baseline and 12 weeks
11-dehydrothromboxane B2 (TXB2): Difference From Baseline
Difference from baseline to visit 7
baseline and 12 weeks
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)
The values of the trough plasma concentration of dabigatran (BIBR 953) are the by-patient geometric means of week 1, 4 and 12.
12 weeks
Number of Participants With Increase of Aspartat-Aminotransferase (AST) to >2*Baseline
Increase of AST to more than two times the baseline value
12 weeks
Number of Participants With Increase of Alkaline Phosphatase (AP) to >2*Baseline
Increase of AP to more than two times the baseline value
12 weeks
Number of Participants With Increase of Bilirubin to >2*Baseline
Increase of Bilirubin to more than two times the baseline value
12 weeks
Number of Participants With Increase of Alanine-Aminotransferase (ALT) to >2*Baseline
Number of Participants with Increase of ALT to more than two times the baseline value
12 weeks
Severity of Adverse Events
Total number of patients with any adverse event of worst intensity 'mild', 'moderate' and 'severe'.
12 weeks
La Mesa
California
United States
1160.20.10006 The Ford Research Institute, PA
Pensacola
Florida
United States
1160.20.10004
Port Charlotte
Florida
United States
1160.20.10002
St. Petersburg
Florida
United States
1160.20.10015
Baltimore
Maryland
United States
1160.20.10008
Westminister
Maryland
United States
1160.20.10012
Pittsfield
Massachusetts
United States
1160.20.10007
Troy
Michigan
United States
1160.20.10014
Hawthorne
New York
United States
1160.20.10013
New Hyde Park
New York
United States
1160.20.10009
North Durham
North Carolina
United States
1160.20.10001
Philadelphia
Pennsylvania
United States
1160.20.10005
Germantown
Tennessee
United States
1160.20.45010
Aalborg
Denmark
1160.20.45005 Aarhus Sygehus
Aarhus C
Denmark
1160.20.45007 Medicinsk afdeling
Brædstrup
Denmark
1160.20.45003 Forskningscentret plan 3
Elsinore
Denmark
1160.20.45011 Medicinsk afd.
Esbjerg
Denmark
1160.20.45012 Afdeling B3
Frederikssund
Denmark
1160.20.45004 Herlev Hospital
Herlev
Denmark
1160.20.45009 Medicinsk amb. B8
Holbæk
Denmark
1160.20.45002 Kardiologisk afdeling
Hvidovre
Denmark
1160.20.45014 Hjertemedicinsk afd.
Køge
Denmark
1160.20.45001 Kardiologisk Laboratorium
Odense
Denmark
1160.20.45013 Kardiologisk afd.
Roskilde
Denmark
1160.20.45006 Medicinsk afdeling
Svendborg
Denmark
1160.20.46013 HIA, Mälarsjukhuset
Eskilstuna
Sweden
1160.20.46007 Falu Lasarett
Falun
Sweden
1160.20.46005 Ryhovs Länssjukhus
Jönköping
Sweden
1160.20.46010 Länssjukhuset Kalmar
Kalmar
Sweden
1160.20.46009 Universitetssjukhuset MAS
Malmö
Sweden
1160.20.46008 Vrinnevisjukhuset
Norrköping
Sweden
1160.20.46004 Universitetssjukhuset
Örebro
Sweden
1160.20.46002 Södersjukhuset
Stockholm
Sweden
1160.20.46011 Arytmienheten, Med klin
Stockholm
Sweden
1160.20.46006 Norrlands Universitetssjukhus
Umeå
Sweden
1160.20.46003 Centrallasarettet
Västerås
Sweden
FG002
BIBR 1048 50 mg b.i.d + ASA 325 mg qd
bid (twice daily) oral + qd (once daily) oral
FG003
BIBR 1048 150 mg b.i.d
bid (twice daily) oral
FG004
BIBR 1048 150 mg b.i.d + ASA 81 mg qd
bid (twice daily) oral + qd (once daily) oral
FG005
BIBR 1048 150 mg b.i.d + ASA 325 mg qd
bid (twice daily) oral + qd (once daily) oral
FG006
BIBR 1048 300 mg b.i.d
bid (twice daily) oral
FG007
BIBR 1048 300 mg b.i.d + ASA 81 mg qd
bid (twice daily) oral + qd (once daily) oral
FG008
BIBR 1048 300 mg b.i.d + ASA 325 mg qd
bid (twice daily) oral + qd (once daily) oral
FG009
Warfarin, Dosed to Target INR 2.0 to 3.0
qd (once daily) oral
FG00058 subjectsStarted: Participant was randomised and took at least one dose of randomised study medication
FG00120 subjects
FG00227 subjects
FG00399 subjects
FG00434 subjects
FG00533 subjects
FG00698 subjects
FG00733 subjects
FG00830 subjects
FG00970 subjects
COMPLETED
FG00056 subjectsCompleted: Participant without premature discontinuation in the randomised treatment period
FG00118 subjects
FG00226 subjects
FG00391 subjects
FG00432 subjects
FG00532 subjects
FG00690 subjects
FG00727 subjects
FG00824 subjects
FG00968 subjects
NOT COMPLETED
FG0002 subjects
FG0012 subjects
FG0021 subjects
FG0038 subjects
FG0042 subjects
FG0051 subjects
FG0068 subjects
FG0076 subjects
FG0086 subjects
FG0092 subjects
Type
Comment
Reasons
Adverse Event
FG0002 subjects
FG0012 subjects
FG0021 subjects
FG0036 subjects
FG0041 subjects
FG0051 subjects
FG0066 subjects
FG0076 subjects
FG0084 subjects
FG0090 subjects
Protocol Violation
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG004
Lost to Follow-up
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Withdrawal by Subject
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Other
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG004
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
BIBR 1048 50 mg b.i.d
bid (twice daily) oral
BG001
BIBR 1048 50 mg b.i.d + ASA 81 mg q.d.
bid (twice daily) oral + qd (once daily) oral
BG002
BIBR 1048 50 mg b.i.d + ASA 325 mg qd
bid (twice daily) oral + qd (once daily) oral
BG003
BIBR 1048 150 mg b.i.d
bid (twice daily) oral
BG004
BIBR 1048 150 mg b.i.d + ASA 81 mg qd
bid (twice daily) oral + qd (once daily) oral
BG005
BIBR 1048 150 mg b.i.d + ASA 325 mg qd
bid (twice daily) oral + qd (once daily) oral
BG006
BIBR 1048 300 mg b.i.d
bid (twice daily) oral
BG007
BIBR 1048 300 mg b.i.d + ASA 81 mg qd
bid (twice daily) oral + qd (once daily) oral
BG008
BIBR 1048 300 mg b.i.d + ASA 325 mg qd
bid (twice daily) oral + qd (once daily) oral
BG009
Warfarin, Dosed to Target INR 2.0 to 3.0
qd (once daily) oral
BG010
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00058
BG00120
BG00227
BG00399
BG00434
BG00533
BG00698
BG00733
BG00830
BG00970
BG010502
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
Years
Title
Denominators
Categories
Title
Measurements
BG00069.0± 8.8
BG00170.1± 9.4
BG00271.6± 8.1
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00012
BG0014
BG002
Baseline documentation regarding the atrial fibrillation
Documentation of symptomatic heart failure as specific risk factor
Number
Participants
Title
Denominators
Categories
No
Title
Measurements
BG00041
BG00112
BG002
Baseline documentation regarding left ventricular dysfunction
Documentation of left ventricular dysfunction as specific risk factor
Number
Participants
Title
Denominators
Categories
No
Title
Measurements
BG00041
BG00114
BG002
Baseline documentation regarding symptomatic heart failure or left ventricular dysfunction
Documentation of symptomatic heart failure or left ventricular dysfunction as specific risk factor
Number
Participants
Title
Denominators
Categories
No
Title
Measurements
BG00035
BG00110
Coronary Artery Disease
Documentation of Coronary Artery Disease as inclusion criterion or specific risk factor
Number
participants
Title
Denominators
Categories
no
Title
Measurements
BG00039
BG0011
BG002
D-dimer at baseline N=(56;19;25;88;29;32;85;31;29;63;457)
Mean
Standard Deviation
ng/ml
Title
Denominators
Categories
Title
Measurements
BG000106.8± 104.1
BG001104.5± 62.9
BG002
Soluble fibrin at baseline N=(53;16;23;88;27;29;92;30;25;65;448)
Mean
Standard Deviation
µg/ml
Title
Denominators
Categories
Title
Measurements
BG0004.9± 4.4
BG0015.3± 7.9
BG002
Thromboxane B2 (TXB2) measured at baseline N=(53;20;23;93;30;30;90;31;30;67;467)
Mean
Standard Deviation
pg/mg Creatinine
Title
Denominators
Categories
Title
Measurements
BG0003968.5± 2530.4
BG0013795.9± 2252.9
BG002
ECT at baseline N=(57;20;27;98;34;33;95;33;29;56;482)
Mean
Standard Deviation
seconds
Title
Denominators
Categories
Title
Measurements
BG00032.3± 2.0
BG00131.8± 1.9
BG002
aPTT at baseline N=(57;20;27;98;34;33;96;33;29;57;484)
Mean
Standard Deviation
seconds
Title
Denominators
Categories
Title
Measurements
BG00032.5± 3.0
BG00131.2± 3.5
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Number of Participants With Fatal or Life-threatening Major Bleeding Events
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
All treated patients. No statistical comparisons were performed, due to the extremely small number of events.
Posted
Number
Participants
12 weeks
ID
Title
Description
OG000
BIBR 1048 50 mg b.i.d
bid (twice daily) oral
OG001
BIBR 1048 50 mg b.i.d + ASA 81 mg q.d.
bid (twice daily) oral + qd (once daily) oral
OG002
BIBR 1048 50 mg b.i.d + ASA 325 mg qd
bid (twice daily) oral + qd (once daily) oral
OG003
BIBR 1048 150 mg b.i.d
bid (twice daily) oral
OG004
BIBR 1048 150 mg b.i.d + ASA 81 mg qd
bid (twice daily) oral + qd (once daily) oral
OG005
BIBR 1048 150 mg b.i.d + ASA 325 mg qd
bid (twice daily) oral + qd (once daily) oral
OG006
BIBR 1048 300 mg b.i.d
bid (twice daily) oral
OG007
BIBR 1048 300 mg b.i.d + ASA 81 mg qd
bid (twice daily) oral + qd (once daily) oral
OG008
BIBR 1048 300 mg b.i.d + ASA 325 mg qd
bid (twice daily) oral + qd (once daily) oral
OG009
Warfarin, Dosed to Target INR 2.0 to 3.0
qd (once daily) oral
Units
Counts
Participants
OG00059
OG00121
OG00227
OG003
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG003
Primary
Number of Participants With Minor/Relevant Bleeding Events
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
All treated patients. No statistical comparisons were performed, due to the small number of events per group
Posted
Number
Participants
12 weeks
ID
Title
Description
OG000
BIBR 1048 50 mg b.i.d
bid (twice daily) oral
OG001
BIBR 1048 50 mg b.i.d + ASA 81 mg q.d.
bid (twice daily) oral + qd (once daily) oral
OG002
BIBR 1048 50 mg b.i.d + ASA 325 mg qd
bid (twice daily) oral + qd (once daily) oral
OG003
BIBR 1048 150 mg b.i.d
bid (twice daily) oral
OG004
BIBR 1048 150 mg b.i.d + ASA 81 mg qd
Primary
Number of Participants With Minor/Nuisance Bleeding Events
All bleeding events not fulfilling one of the criteria for major bleeding event or minor/relevant bleeding events.
All treated patients. No statistical comparisons were performed, due to the small number of events per group
Posted
Number
Participants
12 weeks
ID
Title
Description
OG000
BIBR 1048 50 mg b.i.d
bid (twice daily) oral
OG001
BIBR 1048 50 mg b.i.d + ASA 81 mg q.d.
bid (twice daily) oral + qd (once daily) oral
OG002
BIBR 1048 50 mg b.i.d + ASA 325 mg qd
bid (twice daily) oral + qd (once daily) oral
OG003
BIBR 1048 150 mg b.i.d
bid (twice daily) oral
OG004
BIBR 1048 150 mg b.i.d + ASA 81 mg qd
Secondary
Number of Participants With Thromboembolic Events: Composite Endpoint
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
All randomized patients. No statistical comparisons were performed, due to the extremely small number of events.
Posted
Number
Participants
12 weeks
ID
Title
Description
OG000
BIBR 1048 50 mg b.i.d
bid (twice daily) oral
OG001
BIBR 1048 50 mg b.i.d + ASA 81 mg q.d.
bid (twice daily) oral + qd (once daily) oral
OG002
BIBR 1048 50 mg b.i.d + ASA 325 mg qd
bid (twice daily) oral + qd (once daily) oral
OG003
BIBR 1048 150 mg b.i.d
bid (twice daily) oral
OG004
BIBR 1048 150 mg b.i.d + ASA 81 mg qd
Secondary
Number of Participants With Thromboembolic Events: Ischemic Stroke
Occurence of an ischemic stroke (fatal or non-fatal)
All randomized patients. No statistical comparisons were performed, due to the extremely small number of events.
Posted
Number
Participants
12 weeks
ID
Title
Description
OG000
BIBR 1048 50 mg b.i.d
bid (twice daily) oral
OG001
BIBR 1048 50 mg b.i.d + ASA 81 mg q.d.
bid (twice daily) oral + qd (once daily) oral
OG002
BIBR 1048 50 mg b.i.d + ASA 325 mg qd
bid (twice daily) oral + qd (once daily) oral
OG003
BIBR 1048 150 mg b.i.d
bid (twice daily) oral
OG004
BIBR 1048 150 mg b.i.d + ASA 81 mg qd
bid (twice daily) oral + qd (once daily) oral
Secondary
Thromboembolic Events: Number of Participants With Transient Ischemic Attack
Occurence of a transient ischemic attack
All randomized patients. No statistical comparisons were performed, due to the extremely small number of events.
Posted
Number
Participants
12 weeks
ID
Title
Description
OG000
BIBR 1048 50 mg b.i.d
bid (twice daily) oral
OG001
BIBR 1048 50 mg b.i.d + ASA 81 mg q.d.
bid (twice daily) oral + qd (once daily) oral
OG002
BIBR 1048 50 mg b.i.d + ASA 325 mg qd
bid (twice daily) oral + qd (once daily) oral
OG003
BIBR 1048 150 mg b.i.d
bid (twice daily) oral
OG004
BIBR 1048 150 mg b.i.d + ASA 81 mg qd
bid (twice daily) oral + qd (once daily) oral
Secondary
Thromboembolic Events: Number of Participants With Systemic Thromboembolism
Occurence of a systemic thromboembolism
All randomized patients. No statistical comparisons were performed, due to the extremely small number of events.
Posted
Number
Participants
12 weeks
ID
Title
Description
OG000
BIBR 1048 50 mg b.i.d
bid (twice daily) oral
OG001
BIBR 1048 50 mg b.i.d + ASA 81 mg q.d.
bid (twice daily) oral + qd (once daily) oral
OG002
BIBR 1048 50 mg b.i.d + ASA 325 mg qd
bid (twice daily) oral + qd (once daily) oral
OG003
BIBR 1048 150 mg b.i.d
bid (twice daily) oral
OG004
BIBR 1048 150 mg b.i.d + ASA 81 mg qd
bid (twice daily) oral + qd (once daily) oral
Secondary
Thromboembolic Events: Number of Participants With Myocardial Infarction
Occurence of a myocardial infarction
All randomized patients. No statistical comparisons were performed, due to the extremely small number of events.
Posted
Number
Participants
12 weeks
ID
Title
Description
OG000
BIBR 1048 50 mg b.i.d
bid (twice daily) oral
OG001
BIBR 1048 50 mg b.i.d + ASA 81 mg q.d.
bid (twice daily) oral + qd (once daily) oral
OG002
BIBR 1048 50 mg b.i.d + ASA 325 mg qd
bid (twice daily) oral + qd (once daily) oral
OG003
BIBR 1048 150 mg b.i.d
bid (twice daily) oral
OG004
BIBR 1048 150 mg b.i.d + ASA 81 mg qd
bid (twice daily) oral + qd (once daily) oral
Secondary
Thromboembolic Events: Number of Participants With Other Major Cardiac Events
Occurence of other major adverse cardiac events
All randomized patients. No statistical comparisons were performed, due to the extremely small number of events.
Posted
Number
Participants
12 weeks
ID
Title
Description
OG000
BIBR 1048 50 mg b.i.d
bid (twice daily) oral
OG001
BIBR 1048 50 mg b.i.d + ASA 81 mg q.d.
bid (twice daily) oral + qd (once daily) oral
OG002
BIBR 1048 50 mg b.i.d + ASA 325 mg qd
bid (twice daily) oral + qd (once daily) oral
OG003
BIBR 1048 150 mg b.i.d
bid (twice daily) oral
OG004
BIBR 1048 150 mg b.i.d + ASA 81 mg qd
bid (twice daily) oral + qd (once daily) oral
Secondary
Thromboembolic Events: Number of Participants Who Died
Occurence of death by all causes
All randomized patients. No statistical comparisons were performed, due to the extremely small number of events.
Posted
Number
Participants
12 weeks
ID
Title
Description
OG000
BIBR 1048 50 mg b.i.d
bid (twice daily) oral
OG001
BIBR 1048 50 mg b.i.d + ASA 81 mg q.d.
bid (twice daily) oral + qd (once daily) oral
OG002
BIBR 1048 50 mg b.i.d + ASA 325 mg qd
bid (twice daily) oral + qd (once daily) oral
OG003
BIBR 1048 150 mg b.i.d
bid (twice daily) oral
OG004
BIBR 1048 150 mg b.i.d + ASA 81 mg qd
bid (twice daily) oral + qd (once daily) oral
Secondary
D-dimer: Difference From Baseline
Difference in D-dimer from baseline to last available value
All randomised patients, only per-protocol data included.
Posted
Mean
Standard Deviation
ng/ml
baseline and 12 weeks
ID
Title
Description
OG000
BIBR 1048 50 mg b.i.d
bid (twice daily) oral
OG001
BIBR 1048 50 mg b.i.d + ASA 81 mg q.d.
bid (twice daily) oral + qd (once daily) oral
OG002
BIBR 1048 50 mg b.i.d + ASA 325 mg qd
bid (twice daily) oral + qd (once daily) oral
OG003
BIBR 1048 150 mg b.i.d
bid (twice daily) oral
OG004
BIBR 1048 150 mg b.i.d + ASA 81 mg qd
bid (twice daily) oral + qd (once daily) oral
Secondary
Soluble Fibrin: Difference From Baseline
Difference from baseline to visit 7
All randomised patients, only per-protocol data included.
Posted
Mean
Standard Deviation
µg/ml
baseline and 12 weeks
ID
Title
Description
OG000
BIBR 1048 50 mg b.i.d
bid (twice daily) oral
OG001
BIBR 1048 50 mg b.i.d + ASA 81 mg q.d.
bid (twice daily) oral + qd (once daily) oral
OG002
BIBR 1048 50 mg b.i.d + ASA 325 mg qd
bid (twice daily) oral + qd (once daily) oral
OG003
BIBR 1048 150 mg b.i.d
bid (twice daily) oral
OG004
BIBR 1048 150 mg b.i.d + ASA 81 mg qd
bid (twice daily) oral + qd (once daily) oral
Secondary
11-dehydrothromboxane B2 (TXB2): Difference From Baseline
Difference from baseline to visit 7
All treated patients. No statistical comparisons due to high variability
Posted
Mean
Standard Deviation
pg/mg Creatinine
baseline and 12 weeks
ID
Title
Description
OG000
BIBR 1048 50 mg b.i.d
bid (twice daily) oral
OG001
BIBR 1048 50 mg b.i.d + ASA 81 mg q.d.
bid (twice daily) oral + qd (once daily) oral
OG002
BIBR 1048 50 mg b.i.d + ASA 325 mg qd
bid (twice daily) oral + qd (once daily) oral
OG003
BIBR 1048 150 mg b.i.d
bid (twice daily) oral
OG004
BIBR 1048 150 mg b.i.d + ASA 81 mg qd
bid (twice daily) oral + qd (once daily) oral
Secondary
Ecarin Clotting Time (ECT): Difference From Baseline
All treated patients. No statistical comparisons due to high variability
Posted
Mean
Standard Deviation
seconds
baseline and 12 weeks
ID
Title
Description
OG000
BIBR 1048 50 mg b.i.d
bid (twice daily) oral
OG001
BIBR 1048 50 mg b.i.d + ASA 81 mg q.d.
bid (twice daily) oral + qd (once daily) oral
OG002
BIBR 1048 50 mg b.i.d + ASA 325 mg qd
bid (twice daily) oral + qd (once daily) oral
OG003
BIBR 1048 150 mg b.i.d
bid (twice daily) oral
OG004
BIBR 1048 150 mg b.i.d + ASA 81 mg qd
bid (twice daily) oral + qd (once daily) oral
OG005
Secondary
Activated Partial Thromboplastin Time (aPTT): Difference From Baseline
All treated patients. No statistical comparisons due to high variability
Posted
Mean
Standard Deviation
seconds
baseline and 12 weeks
ID
Title
Description
OG000
BIBR 1048 50 mg b.i.d
bid (twice daily) oral
OG001
BIBR 1048 50 mg b.i.d + ASA 81 mg q.d.
bid (twice daily) oral + qd (once daily) oral
OG002
BIBR 1048 50 mg b.i.d + ASA 325 mg qd
bid (twice daily) oral + qd (once daily) oral
OG003
BIBR 1048 150 mg b.i.d
bid (twice daily) oral
OG004
BIBR 1048 150 mg b.i.d + ASA 81 mg qd
bid (twice daily) oral + qd (once daily) oral
OG005
Secondary
Trough Plasma Concentration of Dabigatran (BIBR 953)
The values of the trough plasma concentration of dabigatran (BIBR 953) are the by-patient geometric means of week 1, 4 and 12.
All treated patients
Posted
Mean
Standard Deviation
ng/ml
12 weeks
ID
Title
Description
OG000
BIBR 1048 50 mg b.i.d
bid (twice daily) oral
OG001
BIBR 1048 50 mg b.i.d + ASA 81 mg q.d.
bid (twice daily) oral + qd (once daily) oral
OG002
BIBR 1048 50 mg b.i.d + ASA 325 mg qd
bid (twice daily) oral + qd (once daily) oral
OG003
BIBR 1048 150 mg b.i.d
bid (twice daily) oral
OG004
BIBR 1048 150 mg b.i.d + ASA 81 mg qd
bid (twice daily) oral + qd (once daily) oral
Secondary
Number of Participants With Increase of Aspartat-Aminotransferase (AST) to >2*Baseline
Increase of AST to more than two times the baseline value
All treated patients. No statistical comparisons due to extremely small number of cases
Posted
Number
Participants
12 weeks
ID
Title
Description
OG000
BIBR 1048 50 mg b.i.d
bid (twice daily) oral
OG001
BIBR 1048 50 mg b.i.d + ASA 81 mg q.d.
bid (twice daily) oral + qd (once daily) oral
OG002
BIBR 1048 50 mg b.i.d + ASA 325 mg qd
bid (twice daily) oral + qd (once daily) oral
OG003
BIBR 1048 150 mg b.i.d
bid (twice daily) oral
OG004
BIBR 1048 150 mg b.i.d + ASA 81 mg qd
bid (twice daily) oral + qd (once daily) oral
Secondary
Number of Participants With Increase of Alkaline Phosphatase (AP) to >2*Baseline
Increase of AP to more than two times the baseline value
All treated patients. No statistical comparisons due to extremely small number of cases
Posted
Number
Participants
12 weeks
ID
Title
Description
OG000
BIBR 1048 50 mg b.i.d
bid (twice daily) oral
OG001
BIBR 1048 50 mg b.i.d + ASA 81 mg q.d.
bid (twice daily) oral + qd (once daily) oral
OG002
BIBR 1048 50 mg b.i.d + ASA 325 mg qd
bid (twice daily) oral + qd (once daily) oral
OG003
BIBR 1048 150 mg b.i.d
bid (twice daily) oral
OG004
BIBR 1048 150 mg b.i.d + ASA 81 mg qd
bid (twice daily) oral + qd (once daily) oral
Secondary
Number of Participants With Increase of Bilirubin to >2*Baseline
Increase of Bilirubin to more than two times the baseline value
All treated patients. No statistical comparisons due to extremely small number of cases
Posted
Number
Participants
12 weeks
ID
Title
Description
OG000
BIBR 1048 50 mg b.i.d
bid (twice daily) oral
OG001
BIBR 1048 50 mg b.i.d + ASA 81 mg q.d.
bid (twice daily) oral + qd (once daily) oral
OG002
BIBR 1048 50 mg b.i.d + ASA 325 mg qd
bid (twice daily) oral + qd (once daily) oral
OG003
BIBR 1048 150 mg b.i.d
bid (twice daily) oral
OG004
BIBR 1048 150 mg b.i.d + ASA 81 mg qd
bid (twice daily) oral + qd (once daily) oral
Secondary
Number of Participants With Increase of Alanine-Aminotransferase (ALT) to >2*Baseline
Number of Participants with Increase of ALT to more than two times the baseline value
All treated patients. No statistical comparisons due to extremely small number of cases
Posted
Number
Participants
12 weeks
ID
Title
Description
OG000
BIBR 1048 50 mg b.i.d
bid (twice daily) oral
OG001
BIBR 1048 50 mg b.i.d + ASA 81 mg q.d.
bid (twice daily) oral + qd (once daily) oral
OG002
BIBR 1048 50 mg b.i.d + ASA 325 mg qd
bid (twice daily) oral + qd (once daily) oral
OG003
BIBR 1048 150 mg b.i.d
bid (twice daily) oral
OG004
BIBR 1048 150 mg b.i.d + ASA 81 mg qd
bid (twice daily) oral + qd (once daily) oral
Secondary
Severity of Adverse Events
Total number of patients with any adverse event of worst intensity 'mild', 'moderate' and 'severe'.
Treated patients(Numbers of patients for adverse events are counted for each treatment and are in their sum greater than the total number of patients randomized as 14 patients on Dabigatran with ASA changed treatment,12 patients down titrated Dabigatran bid to qd of which one did the down titration at the same time as the stop of the ASA treatment)
Note that it was foreseen per protocol that all treatments were possibly to be down-titrated to BIBR 1048 q.d.; criteria included creatinine clearance and aPTT. Events are counted to the treatment on which they occurred.
Dabigatran 300 mg once daily + ASA 325 mg once daily
0
1
1
1
EG016
Warfarin
Warfarin once daily
2
70
22
70
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Acute coronary syndrome
Cardiac disorders
MedDRA version 7.1
Systematic Assessment
EG0000 affected59 at risk
EG0010 affected1 at risk
EG0021 affected21 at risk
EG0030 affected27 at risk
EG0040 affected100 at risk
EG0050 affected3 at risk
EG0060 affected36 at risk
EG0070 affected1 at risk
EG0080 affected33 at risk
EG0090 affected1 at risk
EG0100 affected105 at risk
EG0110 affected3 at risk
EG0121 affected34 at risk
EG0130 affected2 at risk
EG0140 affected30 at risk
EG0150 affected1 at risk
EG0160 affected70 at risk
Angina pectoris
Cardiac disorders
MedDRA version 7.1
Systematic Assessment
EG0000 affected59 at risk
EG0010 affected1 at risk
EG0020 affected21 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA version 7.1
Systematic Assessment
EG0000 affected59 at risk
EG0010 affected1 at risk
EG0020 affected21 at risk
EG003
Atrial thrombosis
Cardiac disorders
MedDRA version 7.1
Systematic Assessment
EG0000 affected59 at risk
EG0010 affected1 at risk
EG0021 affected21 at risk
EG003
Cardiac failure
Cardiac disorders
MedDRA version 7.1
Systematic Assessment
EG0000 affected59 at risk
EG0010 affected1 at risk
EG0020 affected21 at risk
EG003
Cardiac failure congestive
Cardiac disorders
MedDRA version 7.1
Systematic Assessment
EG0000 affected59 at risk
EG0010 affected1 at risk
EG0020 affected21 at risk
EG003
Ventricular fibrillation
Cardiac disorders
MedDRA version 7.1
Systematic Assessment
EG0000 affected59 at risk
EG0010 affected1 at risk
EG0020 affected21 at risk
EG003
Ventricular tachycardia
Cardiac disorders
MedDRA version 7.1
Systematic Assessment
EG0000 affected59 at risk
EG0010 affected1 at risk
EG0020 affected21 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA version 7.1
Systematic Assessment
EG0000 affected59 at risk
EG0010 affected1 at risk
EG0020 affected21 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA version 7.1
Systematic Assessment
EG0000 affected59 at risk
EG0010 affected1 at risk
EG0020 affected21 at risk
EG003
Gastric ulcer
Gastrointestinal disorders
MedDRA version 7.1
Systematic Assessment
EG0000 affected59 at risk
EG0010 affected1 at risk
EG0020 affected21 at risk
EG003
Gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA version 7.1
Systematic Assessment
EG0000 affected59 at risk
EG0010 affected1 at risk
EG0020 affected21 at risk
EG003
Ileus
Gastrointestinal disorders
MedDRA version 7.1
Systematic Assessment
EG0000 affected59 at risk
EG0010 affected1 at risk
EG0020 affected21 at risk
EG003
Lower gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA version 7.1
Systematic Assessment
EG0000 affected59 at risk
EG0010 affected1 at risk
EG0020 affected21 at risk
EG003
Oesophageal ulcer
Gastrointestinal disorders
MedDRA version 7.1
Systematic Assessment
EG0000 affected59 at risk
EG0010 affected1 at risk
EG0020 affected21 at risk
EG003
Pancreatitis
Gastrointestinal disorders
MedDRA version 7.1
Systematic Assessment
EG0000 affected59 at risk
EG0010 affected1 at risk
EG0020 affected21 at risk
EG003
Rectal haemorrhage
Gastrointestinal disorders
MedDRA version 7.1
Systematic Assessment
EG0000 affected59 at risk
EG0010 affected1 at risk
EG0020 affected21 at risk
EG003
Asthenia
General disorders
MedDRA version 7.1
Systematic Assessment
EG0000 affected59 at risk
EG0010 affected1 at risk
EG0020 affected21 at risk
EG003
Chest pain
General disorders
MedDRA version 7.1
Systematic Assessment
EG0000 affected59 at risk
EG0010 affected1 at risk
EG0020 affected21 at risk
EG003
Cholecystitis
Hepatobiliary disorders
MedDRA version 7.1
Systematic Assessment
EG0001 affected59 at risk
EG0010 affected1 at risk
EG0020 affected21 at risk
EG003
Cholelithiasis
Hepatobiliary disorders
MedDRA version 7.1
Systematic Assessment
EG0000 affected59 at risk
EG0010 affected1 at risk
EG0020 affected21 at risk
EG003
Diverticulitis
Infections and infestations
MedDRA version 7.1
Systematic Assessment
EG0001 affected59 at risk
EG0010 affected1 at risk
EG0020 affected21 at risk
EG003
Pneumonia
Infections and infestations
MedDRA version 7.1
Systematic Assessment
EG0000 affected59 at risk
EG0010 affected1 at risk
EG0020 affected21 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA version 7.1
Systematic Assessment
EG0000 affected59 at risk
EG0010 affected1 at risk
EG0020 affected21 at risk
EG003
Implantable defibrillator malfunction
Injury, poisoning and procedural complications
MedDRA version 7.1
Systematic Assessment
EG0000 affected59 at risk
EG0010 affected1 at risk
EG0020 affected21 at risk
EG003
Radius fracture
Injury, poisoning and procedural complications
MedDRA version 7.1
Systematic Assessment
EG0000 affected59 at risk
EG0010 affected1 at risk
EG0020 affected21 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA version 7.1
Systematic Assessment
EG0000 affected59 at risk
EG0010 affected1 at risk
EG0020 affected21 at risk
EG003
Blood pressure systolic inspiratory decreased
Investigations
MedDRA version 7.1
Systematic Assessment
EG0000 affected59 at risk
EG0010 affected1 at risk
EG0020 affected21 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA version 7.1
Systematic Assessment
EG0000 affected59 at risk
EG0010 affected1 at risk
EG0020 affected21 at risk
EG003
Neck pain
Musculoskeletal and connective tissue disorders
MedDRA version 7.1
Systematic Assessment
EG0000 affected59 at risk
EG0010 affected1 at risk
EG0020 affected21 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA version 7.1
Systematic Assessment
EG0000 affected59 at risk
EG0010 affected1 at risk
EG0020 affected21 at risk
EG003
Basal cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version 7.1
Systematic Assessment
EG0000 affected59 at risk
EG0010 affected1 at risk
EG0020 affected21 at risk
EG003
Colon cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version 7.1
Systematic Assessment
EG0000 affected59 at risk
EG0010 affected1 at risk
EG0020 affected21 at risk
EG003
Cerebrovascular accident
Nervous system disorders
MedDRA version 7.1
Systematic Assessment
EG0000 affected59 at risk
EG0010 affected1 at risk
EG0021 affected21 at risk
EG003
Epilepsy
Nervous system disorders
MedDRA version 7.1
Systematic Assessment
EG0000 affected59 at risk
EG0010 affected1 at risk
EG0020 affected21 at risk
EG003
Paraesthesia
Nervous system disorders
MedDRA version 7.1
Systematic Assessment
EG0001 affected59 at risk
EG0010 affected1 at risk
EG0020 affected21 at risk
EG003
Syncope
Nervous system disorders
MedDRA version 7.1
Systematic Assessment
EG0000 affected59 at risk
EG0010 affected1 at risk
EG0020 affected21 at risk
EG003
Renal infarct
Renal and urinary disorders
MedDRA version 7.1
Systematic Assessment
EG0000 affected59 at risk
EG0010 affected1 at risk
EG0021 affected21 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA version 7.1
Systematic Assessment
EG0000 affected59 at risk
EG0010 affected1 at risk
EG0020 affected21 at risk
EG003
Respiratory distress
Respiratory, thoracic and mediastinal disorders
MedDRA version 7.1
Systematic Assessment
EG0000 affected59 at risk
EG0010 affected1 at risk
EG0020 affected21 at risk
EG003
Skin discolouration
Skin and subcutaneous tissue disorders
MedDRA version 7.1
Systematic Assessment
EG0001 affected59 at risk
EG0010 affected1 at risk
EG0020 affected21 at risk
EG003
Hip arthroplasty
Surgical and medical procedures
MedDRA version 7.1
Systematic Assessment
EG0001 affected59 at risk
EG0010 affected1 at risk
EG0020 affected21 at risk
EG003
Circulatory collapse
Vascular disorders
MedDRA version 7.1
Systematic Assessment
EG0001 affected59 at risk
EG0010 affected1 at risk
EG0020 affected21 at risk
EG003
Hypotension
Vascular disorders
MedDRA version 7.1
Systematic Assessment
EG0000 affected59 at risk
EG0010 affected1 at risk
EG0020 affected21 at risk
EG003
Peripheral embolism
Vascular disorders
MedDRA version 7.1
Systematic Assessment
EG0001 affected59 at risk
EG0010 affected1 at risk
EG0020 affected21 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Angina pectoris
Cardiac disorders
MedDRA version 7.1
Systematic Assessment
EG0000 affected59 at risk
EG0010 affected1 at risk
EG0020 affected21 at risk
EG0031 affected27 at risk
EG0040 affected100 at risk
EG0050 affected3 at risk
EG0060 affected36 at risk
EG0070 affected1 at risk
EG0081 affected33 at risk
EG0090 affected1 at risk
EG0101 affected105 at risk
EG0110 affected3 at risk
EG0122 affected34 at risk
EG0130 affected2 at risk
EG0140 affected30 at risk
EG0150 affected1 at risk
EG0161 affected70 at risk
Conjunctival haemorrhage
Eye disorders
MedDRA version 7.1
Systematic Assessment
EG0000 affected59 at risk
EG0010 affected1 at risk
EG0020 affected21 at risk
EG003
Eye haemorrhage
Eye disorders
MedDRA version 7.1
Systematic Assessment
EG0000 affected59 at risk
EG0010 affected1 at risk
EG0020 affected21 at risk
EG003
Abdominal distension
Gastrointestinal disorders
MedDRA version 7.1
Systematic Assessment
EG0001 affected59 at risk
EG0010 affected1 at risk
EG0022 affected21 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA version 7.1
Systematic Assessment
EG0001 affected59 at risk
EG0010 affected1 at risk
EG0020 affected21 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA version 7.1
Systematic Assessment
EG0002 affected59 at risk
EG0010 affected1 at risk
EG0020 affected21 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA version 7.1
Systematic Assessment
EG0002 affected59 at risk
EG0010 affected1 at risk
EG0021 affected21 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA version 7.1
Systematic Assessment
EG0003 affected59 at risk
EG0010 affected1 at risk
EG0022 affected21 at risk
EG003
Dry mouth
Gastrointestinal disorders
MedDRA version 7.1
Systematic Assessment
EG0000 affected59 at risk
EG0010 affected1 at risk
EG0020 affected21 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA version 7.1
Systematic Assessment
EG0001 affected59 at risk
EG0010 affected1 at risk
EG0021 affected21 at risk
EG003
Gingival bleeding
Gastrointestinal disorders
MedDRA version 7.1
Systematic Assessment
EG0000 affected59 at risk
EG0010 affected1 at risk
EG0020 affected21 at risk
EG003
Haemorrhoidal haemorrhage
Gastrointestinal disorders
MedDRA version 7.1
Systematic Assessment
EG0000 affected59 at risk
EG0010 affected1 at risk
EG0020 affected21 at risk
EG003
Mouth haemorrhage
Gastrointestinal disorders
MedDRA version 7.1
Systematic Assessment
EG0000 affected59 at risk
EG0010 affected1 at risk
EG0020 affected21 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA version 7.1
Systematic Assessment
EG0002 affected59 at risk
EG0010 affected1 at risk
EG0022 affected21 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA version 7.1
Systematic Assessment
EG0001 affected59 at risk
EG0010 affected1 at risk
EG0020 affected21 at risk
EG003
Chest pain
General disorders
MedDRA version 7.1
Systematic Assessment
EG0000 affected59 at risk
EG0010 affected1 at risk
EG0022 affected21 at risk
EG003
Fatigue
General disorders
MedDRA version 7.1
Systematic Assessment
EG0001 affected59 at risk
EG0010 affected1 at risk
EG0020 affected21 at risk
EG003
Sensation of pressure
General disorders
MedDRA version 7.1
Systematic Assessment
EG0000 affected59 at risk
EG0010 affected1 at risk
EG0020 affected21 at risk
EG003
Influenza
Infections and infestations
MedDRA version 7.1
Systematic Assessment
EG0001 affected59 at risk
EG0010 affected1 at risk
EG0020 affected21 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA version 7.1
Systematic Assessment
EG0002 affected59 at risk
EG0010 affected1 at risk
EG0020 affected21 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA version 7.1
Systematic Assessment
EG0001 affected59 at risk
EG0010 affected1 at risk
EG0021 affected21 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MedDRA version 7.1
Systematic Assessment
EG0000 affected59 at risk
EG0010 affected1 at risk
EG0020 affected21 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA version 7.1
Systematic Assessment
EG0000 affected59 at risk
EG0010 affected1 at risk
EG0020 affected21 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA version 7.1
Systematic Assessment
EG0000 affected59 at risk
EG0010 affected1 at risk
EG0020 affected21 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA version 7.1
Systematic Assessment
EG0000 affected59 at risk
EG0010 affected1 at risk
EG0022 affected21 at risk
EG003
Costochondritis
Musculoskeletal and connective tissue disorders
MedDRA version 7.1
Systematic Assessment
EG0000 affected59 at risk
EG0010 affected1 at risk
EG0020 affected21 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA version 7.1
Systematic Assessment
EG0002 affected59 at risk
EG0010 affected1 at risk
EG0022 affected21 at risk
EG003
Dizziness
Nervous system disorders
MedDRA version 7.1
Systematic Assessment
EG0003 affected59 at risk
EG0010 affected1 at risk
EG0021 affected21 at risk
EG003
Headache
Nervous system disorders
MedDRA version 7.1
Systematic Assessment
EG0002 affected59 at risk
EG0010 affected1 at risk
EG0021 affected21 at risk
EG003
Haematuria
Renal and urinary disorders
MedDRA version 7.1
Systematic Assessment
EG0001 affected59 at risk
EG0010 affected1 at risk
EG0020 affected21 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA version 7.1
Systematic Assessment
EG0001 affected59 at risk
EG0010 affected1 at risk
EG0020 affected21 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA version 7.1
Systematic Assessment
EG0000 affected59 at risk
EG0010 affected1 at risk
EG0020 affected21 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA version 7.1
Systematic Assessment
EG0000 affected59 at risk
EG0010 affected1 at risk
EG0020 affected21 at risk
EG003
Ecchymosis
Skin and subcutaneous tissue disorders
MedDRA version 7.1
Systematic Assessment
EG0000 affected59 at risk
EG0010 affected1 at risk
EG0020 affected21 at risk
EG003
Exanthem
Skin and subcutaneous tissue disorders
MedDRA version 7.1
Systematic Assessment
EG0000 affected59 at risk
EG0010 affected1 at risk
EG0020 affected21 at risk
EG003
Haematoma
Vascular disorders
MedDRA version 7.1
Systematic Assessment
EG0001 affected59 at risk
EG0010 affected1 at risk
EG0020 affected21 at risk
EG003
Hypertension
Vascular disorders
MedDRA version 7.1
Systematic Assessment
EG0001 affected59 at risk
EG0010 affected1 at risk
EG0021 affected21 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
Any publication of the result of this trial must be consistent with the Boehringer Ingelheim publication policy. The rights of the investigator and of the sponsor with regard to publication of the results of this trial are described in the investigator contract.
Point of Contact
Title
Organization
Phone
Extension
Email
Boehringer Ingelheim Call Center
Boehringer Ingelheim Pharmaceuticals
1-800-243-0127
clintriage.rdg@boehringer-ingelheim.com
ID
Term
D001281
Atrial Fibrillation
Ancestor Terms
ID
Term
D001145
Arrhythmias, Cardiac
D006331
Heart Diseases
D002318
Cardiovascular Diseases
D010335
Pathologic Processes
D013568
Pathological Conditions, Signs and Symptoms
Browse Leaves
Not provided
Browse Branches
Not provided
ID
Term
D000069604
Dabigatran
D014859
Warfarin
Ancestor Terms
ID
Term
D011725
Pyridines
D006573
Heterocyclic Compounds, 1-Ring
D006571
Heterocyclic Compounds
D001562
Benzimidazoles
D006574
Heterocyclic Compounds, 2-Ring
D000072471
Heterocyclic Compounds, Fused-Ring
D015110
4-Hydroxycoumarins
D003374
Coumarins
D001578
Benzopyrans
D011714
Pyrans
Browse Leaves
Not provided
Browse Branches
Not provided
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
1 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
0 subjects
FG0050 subjects
FG0062 subjects
FG0070 subjects
FG0080 subjects
FG0091 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0082 subjects
FG0091 subjects
69.7
± 7.7
BG00472.1± 9.0
BG00569.7± 8.0
BG00669.0± 9.1
BG00771.8± 7.2
BG00868.6± 7.1
BG00969.0± 8.3
BG01069.7± 8.3
5
BG00315
BG0048
BG0058
BG00619
BG0077
BG0082
BG00911
BG01091
Male
BG00046
BG00116
BG00222
BG00384
BG00426
BG00525
BG00679
BG00726
BG00828
BG00959
BG010411
10
BG00343
BG00413
BG00510
BG00637
BG00714
BG00812
BG00927
BG010195
Permanent
Title
Measurements
BG00023
BG0019
BG00211
BG00335
BG00411
BG00516
BG00637
BG00710
BG00814
BG00926
BG010192
Paroxysmal
Title
Measurements
BG00015
BG0012
BG0026
BG00321
BG00410
BG0057
BG00624
BG0079
BG0084
BG00917
BG010115
24
BG00393
BG00430
BG00530
BG00691
BG00731
BG00826
BG00962
BG010459
Yes
Title
Measurements
BG0004
BG0012
BG0023
BG0036
BG0044
BG0053
BG0067
BG0072
BG0084
BG0098
BG01043
25
BG00388
BG00431
BG00531
BG00690
BG00730
BG00826
BG00963
BG010453
Yes
Title
Measurements
BG0009
BG0010
BG0022
BG00311
BG0043
BG0052
BG0068
BG0073
BG0084
BG0097
BG01049
23
BG00382
BG00427
BG00528
BG00685
BG00728
BG00822
BG00957
BG010415
Yes
Title
Measurements
BG00013
BG0012
BG0024
BG00317
BG0047
BG0055
BG00613
BG0075
BG0088
BG00913
BG01087
8
BG00321
BG00413
BG00514
BG00624
BG0078
BG00810
BG00921
BG010146
Yes
Title
Measurements
BG00041
BG00110
BG00219
BG00378
BG00421
BG00519
BG00674
BG00725
BG00820
BG00949
BG010356
17
BG00373
BG00420
BG00521
BG00685
BG00720
BG00820
BG00946
BG010355
Yes
Title
Measurements
BG00017
BG0018
BG00210
BG00326
BG00414
BG00512
BG00613
BG00713
BG00810
BG00924
BG010147
17
BG00368
BG00422
BG00519
BG00678
BG00720
BG00814
BG00944
BG010337
Yes
Title
Measurements
BG00017
BG0016
BG00210
BG00331
BG00412
BG00514
BG00620
BG00713
BG00816
BG00926
BG010165
BG00214
BG00355
BG00415
BG00517
BG00671
BG00714
BG00812
BG00934
BG010277
Yes
Title
Measurements
BG00023
BG00110
BG00213
BG00344
BG00419
BG00516
BG00627
BG00719
BG00818
BG00936
BG010225
1
BG00355
BG0043
BG0054
BG00662
BG0072
BG0081
BG00928
BG010196
yes
Title
Measurements
BG00019
BG00119
BG00226
BG00344
BG00431
BG00529
BG00636
BG00731
BG00829
BG00942
BG010306
176.9
± 389.9
BG003100.8± 94.5
BG004120.3± 95.4
BG00596.3± 64.3
BG006146.8± 210.9
BG007119.4± 95.5
BG00883.8± 48.8
BG009139.9± 251.9
BG010120.9± 173.7
5.4
± 5.9
BG0035.8± 8.8
BG0049.1± 15.5
BG0057.6± 14.8
BG0067.4± 11.5
BG0079.2± 26.0
BG0086.5± 9.2
BG0097.2± 10.4
BG0106.8± 11.9
4705.6
± 3047.5
BG0034138.1± 2184.6
BG0044485.7± 2147.8
BG0054084.9± 2253.5
BG0063619.0± 2020.6
BG0074450.8± 2653.7
BG0083735.6± 2440.6
BG0094177.9± 2661.2
BG0104051.6± 2367.7
31.9
± 2.2
BG00331.9± 2.2
BG00432.0± 1.9
BG00532.6± 2.4
BG00633.6± 13.3
BG00731.9± 1.8
BG00832.2± 2.6
BG00932.0± 2.4
BG01032.4± 6.2
32.4
± 3.6
BG00334.2± 15.2
BG00433.5± 7.6
BG00534.2± 6.7
BG00632.8± 5.7
BG00732.6± 3.4
BG00832.9± 6.7
BG00933.2± 3.7
BG01033.1± 8.2
100
OG00436
OG00533
OG006105
OG00734
OG00830
OG00970
0
OG0040
OG0050
OG0060
OG0071
OG0083
OG0090
bid (twice daily) oral + qd (once daily) oral
OG005
BIBR 1048 150 mg b.i.d + ASA 325 mg qd
bid (twice daily) oral + qd (once daily) oral
OG006
BIBR 1048 300 mg b.i.d
bid (twice daily) oral
OG007
BIBR 1048 300 mg b.i.d + ASA 81 mg qd
bid (twice daily) oral + qd (once daily) oral
OG008
BIBR 1048 300 mg b.i.d + ASA 325 mg qd
bid (twice daily) oral + qd (once daily) oral
OG009
Warfarin, Dosed to Target INR 2.0 to 3.0
qd (once daily) oral
Units
Counts
Participants
OG00059
OG00121
OG00227
OG003100
OG00436
OG00533
OG006105
OG00734
OG00830
OG00970
Title
Denominators
Categories
Title
Measurements
OG0000
OG0011
OG0021
OG0039
OG0042
OG0052
OG0066
OG0074
OG0083
OG0094
bid (twice daily) oral + qd (once daily) oral
OG005
BIBR 1048 150 mg b.i.d + ASA 325 mg qd
bid (twice daily) oral + qd (once daily) oral
OG006
BIBR 1048 300 mg b.i.d
bid (twice daily) oral
OG007
BIBR 1048 300 mg b.i.d + ASA 81 mg qd
bid (twice daily) oral + qd (once daily) oral
OG008
BIBR 1048 300 mg b.i.d + ASA 325 mg qd
bid (twice daily) oral + qd (once daily) oral
OG009
Warfarin, Dosed to Target INR 2.0 to 3.0
qd (once daily) oral
Units
Counts
Participants
OG00059
OG00121
OG00227
OG003100
OG00436
OG00533
OG006105
OG00734
OG00830
OG00970
Title
Denominators
Categories
Title
Measurements
OG0002
OG0011
OG0022
OG0036
OG0046
OG0055
OG0069
OG0077
OG0089
OG0099
bid (twice daily) oral + qd (once daily) oral
OG005
BIBR 1048 150 mg b.i.d + ASA 325 mg qd
bid (twice daily) oral + qd (once daily) oral
OG006
BIBR 1048 300 mg b.i.d
bid (twice daily) oral
OG007
BIBR 1048 300 mg b.i.d + ASA 81 mg qd
bid (twice daily) oral + qd (once daily) oral
OG008
BIBR 1048 300 mg b.i.d + ASA 325 mg qd
bid (twice daily) oral + qd (once daily) oral
OG009
Warfarin, Dosed to Target INR 2.0 to 3.0
qd (once daily) oral
Units
Counts
Participants
OG00058
OG00120
OG00227
OG00399
OG00434
OG00533
OG00698
OG00733
OG00830
OG00970
Title
Denominators
Categories
Title
Measurements
OG0001
OG0012
OG0021
OG0030
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
OG005
BIBR 1048 150 mg b.i.d + ASA 325 mg qd
bid (twice daily) oral + qd (once daily) oral
OG006
BIBR 1048 300 mg b.i.d
bid (twice daily) oral
OG007
BIBR 1048 300 mg b.i.d + ASA 81 mg qd
bid (twice daily) oral + qd (once daily) oral
OG008
BIBR 1048 300 mg b.i.d + ASA 325 mg qd
bid (twice daily) oral + qd (once daily) oral
OG009
Warfarin, Dosed to Target INR 2.0 to 3.0
qd (once daily) oral
Units
Counts
Participants
OG00058
OG00120
OG00227
OG00399
OG00434
OG00533
OG00698
OG00733
OG00830
OG00970
Title
Denominators
Categories
None
Title
Measurements
OG00058
OG00119
OG00227
OG00399
OG00434
OG00533
OG00698
OG00733
OG00830
OG00970
Fatal
Title
Measurements
OG0000
OG0010
OG0020
OG003
Non-Fatal
Title
Measurements
OG0000
OG0011
OG0020
OG003
Both
Title
Measurements
OG0000
OG0010
OG0020
OG003
OG005
BIBR 1048 150 mg b.i.d + ASA 325 mg qd
bid (twice daily) oral + qd (once daily) oral
OG006
BIBR 1048 300 mg b.i.d
bid (twice daily) oral
OG007
BIBR 1048 300 mg b.i.d + ASA 81 mg qd
bid (twice daily) oral + qd (once daily) oral
OG008
BIBR 1048 300 mg b.i.d + ASA 325 mg qd
bid (twice daily) oral + qd (once daily) oral
OG009
Warfarin, Dosed to Target INR 2.0 to 3.0
qd (once daily) oral
Units
Counts
Participants
OG00058
OG00120
OG00227
OG00399
OG00434
OG00533
OG00698
OG00733
OG00830
OG00970
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
OG005
BIBR 1048 150 mg b.i.d + ASA 325 mg qd
bid (twice daily) oral + qd (once daily) oral
OG006
BIBR 1048 300 mg b.i.d
bid (twice daily) oral
OG007
BIBR 1048 300 mg b.i.d + ASA 81 mg qd
bid (twice daily) oral + qd (once daily) oral
OG008
BIBR 1048 300 mg b.i.d + ASA 325 mg qd
bid (twice daily) oral + qd (once daily) oral
OG009
Warfarin, Dosed to Target INR 2.0 to 3.0
qd (once daily) oral
Units
Counts
Participants
OG00058
OG00120
OG00227
OG00399
OG00434
OG00533
OG00698
OG00733
OG00830
OG00970
Title
Denominators
Categories
Title
Measurements
OG0001
OG0011
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
OG005
BIBR 1048 150 mg b.i.d + ASA 325 mg qd
bid (twice daily) oral + qd (once daily) oral
OG006
BIBR 1048 300 mg b.i.d
bid (twice daily) oral
OG007
BIBR 1048 300 mg b.i.d + ASA 81 mg qd
bid (twice daily) oral + qd (once daily) oral
OG008
BIBR 1048 300 mg b.i.d + ASA 325 mg qd
bid (twice daily) oral + qd (once daily) oral
OG009
Warfarin, Dosed to Target INR 2.0 to 3.0
qd (once daily) oral
Units
Counts
Participants
OG00058
OG00120
OG00227
OG00399
OG00434
OG00533
OG00698
OG00733
OG00830
OG00970
Title
Denominators
Categories
None
Title
Measurements
OG00058
OG00120
OG00227
OG00399
OG00434
OG00533
OG00698
OG00733
OG00830
OG00970
Fatal
Title
Measurements
OG0000
OG0010
OG0020
OG003
Non-Fatal
Title
Measurements
OG0000
OG0010
OG0020
OG003
Both
Title
Measurements
OG0000
OG0010
OG0020
OG003
OG005
BIBR 1048 150 mg b.i.d + ASA 325 mg qd
bid (twice daily) oral + qd (once daily) oral
OG006
BIBR 1048 300 mg b.i.d
bid (twice daily) oral
OG007
BIBR 1048 300 mg b.i.d + ASA 81 mg qd
bid (twice daily) oral + qd (once daily) oral
OG008
BIBR 1048 300 mg b.i.d + ASA 325 mg qd
bid (twice daily) oral + qd (once daily) oral
OG009
Warfarin, Dosed to Target INR 2.0 to 3.0
qd (once daily) oral
Units
Counts
Participants
OG00058
OG00120
OG00227
OG00399
OG00434
OG00533
OG00698
OG00733
OG00830
OG00970
Title
Denominators
Categories
Title
Measurements
OG0000
OG0011
OG0021
OG0030
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
OG005
BIBR 1048 150 mg b.i.d + ASA 325 mg qd
bid (twice daily) oral + qd (once daily) oral
OG006
BIBR 1048 300 mg b.i.d
bid (twice daily) oral
OG007
BIBR 1048 300 mg b.i.d + ASA 81 mg qd
bid (twice daily) oral + qd (once daily) oral
OG008
BIBR 1048 300 mg b.i.d + ASA 325 mg qd
bid (twice daily) oral + qd (once daily) oral
OG009
Warfarin, Dosed to Target INR 2.0 to 3.0
qd (once daily) oral
Units
Counts
Participants
OG00058
OG00120
OG00227
OG00399
OG00434
OG00533
OG00698
OG00733
OG00830
OG00970
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
OG005
BIBR 1048 150 mg b.i.d + ASA 325 mg qd
bid (twice daily) oral + qd (once daily) oral
OG006
BIBR 1048 300 mg b.i.d
bid (twice daily) oral
OG007
BIBR 1048 300 mg b.i.d + ASA 81 mg qd
bid (twice daily) oral + qd (once daily) oral
OG008
BIBR 1048 300 mg b.i.d + ASA 325 mg qd
bid (twice daily) oral + qd (once daily) oral
OG009
Warfarin, Dosed to Target INR 2.0 to 3.0
qd (once daily) oral
Units
Counts
Participants
OG00055
OG00119
OG00226
OG00387
OG00429
OG00532
OG00688
OG00729
OG00829
OG00963
Title
Denominators
Categories
Title
Measurements
OG00022.3± 65.4
OG00112.3± 25.3
OG00250.2± 182.8
OG0038.1± 41.6
OG00429.1± 90.4
OG0058.6± 49.2
OG0064.2± 95.8
OG00711.3± 82.2
OG008-7.9± 40.9
OG009-5.8± 50.6
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
OG002
OG003
OG004
OG005
OG006
OG007
OG008
OG009
Group comparison of differences from baseline to last available value
Kruskal-Wallis
0.0357
95
No
Superiority or Other
OG005
BIBR 1048 150 mg b.i.d + ASA 325 mg qd
bid (twice daily) oral + qd (once daily) oral
OG006
BIBR 1048 300 mg b.i.d
bid (twice daily) oral
OG007
BIBR 1048 300 mg b.i.d + ASA 81 mg qd
bid (twice daily) oral + qd (once daily) oral
OG008
BIBR 1048 300 mg b.i.d + ASA 325 mg qd
bid (twice daily) oral + qd (once daily) oral
OG009
Warfarin, Dosed to Target INR 2.0 to 3.0
qd (once daily) oral
Units
Counts
Participants
OG00052
OG00115
OG00225
OG00388
OG00425
OG00524
OG00683
OG00727
OG00820
OG00954
Title
Denominators
Categories
Title
Measurements
OG0003.2± 22.0
OG0010.9± 2.3
OG0021.2± 8.4
OG0030.3± 5.1
OG004-2.0± 9.9
OG005-1.3± 8.8
OG0062.3± 26.8
OG007-0.7± 4.6
OG008-1.9± 12.0
OG0090.1± 4.0
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
OG002
OG003
OG004
OG005
OG006
OG007
OG008
OG009
Group comparison of differences from baseline to week 12