Atrial FibrillationPhase 2NCT01227629

PETRO Stroke Prevention in Patients With AF by Treatment With Dabigatran, With and Without Aspirin, Compared to Warfarin

A Phase 2 study testing dabigatran with ASA, warfarin and dabigatran without ASA in people with Atrial Fibrillation, run by Boehringer Ingelheim at 38 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Atrial Fibrillation
What is being tested?: dabigatran with ASA, warfarin and dabigatran without ASA
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 502 participants
Where: 38 sitesin 3 countries
Study dates: Sep 2003to Nov 2004
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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%).

Show all 12Show fewer

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.

Who cannot join

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).

Show all 19Show fewer

Severe renal impairment (estimated glomerular filtration rate (GFR) =< 30 mL/min).
Uncontrolled hypertension (SBP > 180 mmHg and/or DBP > 100 mmHg).
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).

Trial locations and contacts

38 sites in 3 countries.

Country

City, postcode or hospital

38 sites in 3 countries

United States14 sites

1160.20.10015
Baltimore, Maryland
1160.20.10010
Fayetteville, Arkansas
1160.20.10005
Germantown, Tennessee
1160.20.10014
Hawthorne, New York
1160.20.10003 La Mesa Cardiac
La Mesa, California
1160.20.10013
New Hyde Park, New York
1160.20.10009
North Durham, North Carolina
1160.20.10006 The Ford Research Institute, PA
Pensacola, Florida
1160.20.10001
Philadelphia, Pennsylvania
1160.20.10012
Pittsfield, Massachusetts
1160.20.10004
Port Charlotte, Florida
1160.20.10002
St. Petersburg, Florida
1160.20.10007
Troy, Michigan
1160.20.10008
Westminister, Maryland

Other trials in United States

Denmark13 sites

1160.20.45010
Aalborg
1160.20.45005 Aarhus Sygehus
Aarhus C
1160.20.45007 Medicinsk afdeling
Brædstrup
1160.20.45003 Forskningscentret plan 3
Elsinore
1160.20.45011 Medicinsk afd.
Esbjerg
1160.20.45012 Afdeling B3
Frederikssund
1160.20.45004 Herlev Hospital
Herlev
1160.20.45009 Medicinsk amb. B8
Holbæk
1160.20.45002 Kardiologisk afdeling
Hvidovre
1160.20.45014 Hjertemedicinsk afd.
Køge
1160.20.45001 Kardiologisk Laboratorium
Odense
1160.20.45013 Kardiologisk afd.
Roskilde
1160.20.45006 Medicinsk afdeling
Svendborg

Other trials in Denmark

Sweden11 sites

1160.20.46013 HIA, Mälarsjukhuset
Eskilstuna
1160.20.46007 Falu Lasarett
Falun
1160.20.46005 Ryhovs Länssjukhus
Jönköping
1160.20.46010 Länssjukhuset Kalmar
Kalmar
1160.20.46009 Universitetssjukhuset MAS
Malmö
1160.20.46008 Vrinnevisjukhuset
Norrköping
1160.20.46004 Universitetssjukhuset
Örebro
1160.20.46002 Södersjukhuset
Stockholm
1160.20.46011 Arytmienheten, Med klin
Stockholm
1160.20.46006 Norrlands Universitetssjukhus
Umeå
1160.20.46003 Centrallasarettet
Västerås

Other trials in Sweden

About this study

Official title: Dose Exploration in Patients With Atrial Fibrillation

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: Atrial Fibrillation
Being tested: dabigatran with ASA, warfarin, dabigatran without ASA
Medical subject headings: Atrial Fibrillation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

dabigatran with ASADrug
dose comparison in combination
dabigatran with ASADrug
dose comparison in combination
dabigatran with ASADrug
dose comparison in combination
dabigatran with ASADrug
dose comparison in combination
dabigatran with ASADrug
dose comparison in combination
dabigatran with ASADrug
dose comparison in combination
warfarinDrug
comparator
dabigatran without ASADrug
dose comparison
dabigatran without ASADrug
dose comparison
dabigatran without ASADrug
dose comparison

Study groups in NCT01227629
Study group	Role	What they receive
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). Receives: 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. Receives: 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 Receives: Drug: dabigatran with ASA
dabigatran 150 mg bid	Experimental	Dabigatran: one capsule in the morning and 1 capsule in the evening Receives: 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 Receives: Drug: dabigatran with ASA
dabigatran 150 mg bid + 325 mg ASA qd	Experimental	Dabigatran: one capsule in the morning and 1 capsule in the evening. ASA in the morning Receives: Drug: dabigatran with ASA
dabigatran 300 mg bid	Experimental	Dabigatran: one capsule in the morning and 1 capsule in the evening Receives: 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 Receives: 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 Receives: Drug: dabigatran with ASA
warfarin	Active comparator	once daily, dosed to target International Normalised Ratio (INR) 2.0 to 3.0 Receives: Drug: warfarin

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: 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
Measured: 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.
Measured: 12 weeks

Secondary outcomes (18)

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
Measured: 12 weeks
Number of Participants With Thromboembolic Events: Ischemic Stroke
Occurence of an ischemic stroke (fatal or non-fatal)
Measured: 12 weeks
Thromboembolic Events: Number of Participants With Transient Ischemic Attack
Occurence of a transient ischemic attack
Measured: 12 weeks
Thromboembolic Events: Number of Participants With Systemic Thromboembolism
Occurence of a systemic thromboembolism
Measured: 12 weeks
Thromboembolic Events: Number of Participants With Myocardial Infarction
Occurence of a myocardial infarction
Measured: 12 weeks
Thromboembolic Events: Number of Participants With Other Major Cardiac Events
Occurence of other major adverse cardiac events
Measured: 12 weeks
Thromboembolic Events: Number of Participants Who Died
Occurence of death by all causes
Measured: 12 weeks
D-dimer: Difference From Baseline
Difference in D-dimer from baseline to last available value
Measured: baseline and 12 weeks
Soluble Fibrin: Difference From Baseline
Difference from baseline to visit 7
Measured: baseline and 12 weeks
11-dehydrothromboxane B2 (TXB2): Difference From Baseline
Difference from baseline to visit 7
Measured: baseline and 12 weeks
Ecarin Clotting Time (ECT): Difference From Baseline
Measured: baseline and 12 weeks
Activated Partial Thromboplastin Time (aPTT): Difference From Baseline
Measured: 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.
Measured: 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
Measured: 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
Measured: 12 weeks
Number of Participants With Increase of Bilirubin to >2*Baseline
Increase of Bilirubin to more than two times the baseline value
Measured: 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
Measured: 12 weeks
Severity of Adverse Events
Total number of patients with any adverse event of worst intensity 'mild', 'moderate' and 'severe'.
Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2003Nov 2004

First posted25 Oct 2010 (estimated)
Study startSep 2003
Primary completionNov 2004

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Atrial FibrillationStudies of the same condition, open and under way.
More trials run by Boehringer IngelheimThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Enrolment: 502 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01227629
Sponsor's protocol ID: 1160.20
Other IDs: PETRO trial
Status last verified: Apr 2014
First submitted: 22 Oct 2010
Last updated: 5 May 2014
Results posted: Yes, on ClinicalTrials.gov

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruiting
Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)
Paroxysmal AF
Active, not recruitingObservational study
Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
Concomitant Procedures, Atrial Fibrillation
Active, not recruiting
CONVERGE Post-Approval Study (PAS)
Chronic Atrial Fibrillation
Recruiting
Early Closure of Left Atrial Appendage for Patients With Atrial Fibrillation and Ischemic Stroke Despite Anticoagulation Therapy
Ischemic Stroke, Atrial Fibrillation
RecruitingPhase 2
Safety in Adult Participants With Atrial Fibrillation Who Are Treated With Anticoagulation
Atrial Fibrillation (AF)

All Atrial Fibrillation trials

Study at a glance

From the registry record, last updated by the sponsor on 5 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Dose Exploration in Patients With Atrial Fibrillation
ClinicalTrials.gov ID: NCT01227629
Acronym / sponsor ID: 1160.20
Conditions: Atrial Fibrillation
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 502 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: Sep 2003
Primary completion: Nov 2004 (actual)
First posted: 25 Oct 2010 (estimated)
Results: Posted 10 Feb 2011

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Number of arms: 10

Arm	Type	Receives
dabigatran 50 mg twice daily (bid)	Experimental	Drug: dabigatran without ASADabigatran: 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	Experimental	Drug: dabigatran with ASADabigatran: 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	Experimental	Drug: dabigatran with ASADabigatran: one capsule in the morning and 1 capsule in the evening. ASA in the morning
dabigatran 150 mg bid	Experimental	Drug: dabigatran without ASADabigatran: one capsule in the morning and 1 capsule in the evening
dabigatran 150 mg bid + 81 mg ASA qd	Experimental	Drug: dabigatran with ASADabigatran: one capsule in the morning and 1 capsule in the evening. ASA in the morning
dabigatran 150 mg bid + 325 mg ASA qd	Experimental	Drug: dabigatran with ASADabigatran: one capsule in the morning and 1 capsule in the evening. ASA in the morning
dabigatran 300 mg bid	Experimental	Drug: dabigatran without ASADabigatran: one capsule in the morning and 1 capsule in the evening
dabigatran 300 mg bid + 81 mg ASA qd	Experimental	Drug: dabigatran with ASADabigatran: one capsule in the morning and 1 capsule in the evening. ASA in the morning
dabigatran 300 mg bid + 325 mg ASA qd	Experimental	Drug: dabigatran with ASADabigatran: one capsule in the morning and 1 capsule in the evening. ASA in the morning
warfarin	Active comparator	Drug: warfarinonce daily, dosed to target International Normalised Ratio (INR) 2.0 to 3.0

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (12 listed)

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:
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.

Key exclusion criteria (19 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
dabigatran with ASAdose comparison in combination	Drug	dabigatran 50 mg bid + 81 mg ASA qd
dabigatran with ASAdose comparison in combination	Drug	dabigatran 50 mg bid + 325 mg ASA qd
dabigatran with ASAdose comparison in combination	Drug	dabigatran 150 mg bid + 81 mg ASA qd
dabigatran with ASAdose comparison in combination	Drug	dabigatran 150 mg bid + 325 mg ASA qd
dabigatran with ASAdose comparison in combination	Drug	dabigatran 300 mg bid + 81 mg ASA qd
dabigatran with ASAdose comparison in combination	Drug	dabigatran 300 mg bid + 325 mg ASA qd
warfarincomparator	Drug	warfarin
dabigatran without ASAdose comparison	Drug	dabigatran 50 mg twice daily (bid)
dabigatran without ASAdose comparison	Drug	dabigatran 150 mg bid
dabigatran without ASAdose comparison	Drug	dabigatran 300 mg bid

Primary outcome

Number of Participants With Fatal or Life-threatening Major Bleeding Events
Time frame: 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
Time frame: 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
Time frame: 12 weeks
All bleeding events not fulfilling one of the criteria for major bleeding event or minor/relevant bleeding events.

18 secondary outcomes

Number of Participants With Thromboembolic Events: Composite Endpoint
Time frame: 12 weeks
Number of Participants With Thromboembolic Events: Ischemic Stroke
Time frame: 12 weeks
Thromboembolic Events: Number of Participants With Transient Ischemic Attack
Time frame: 12 weeks
Thromboembolic Events: Number of Participants With Systemic Thromboembolism
Time frame: 12 weeks
Thromboembolic Events: Number of Participants With Myocardial Infarction
Time frame: 12 weeks
Thromboembolic Events: Number of Participants With Other Major Cardiac Events
Time frame: 12 weeks
Thromboembolic Events: Number of Participants Who Died
Time frame: 12 weeks
D-dimer: Difference From Baseline
Time frame: baseline and 12 weeks
Soluble Fibrin: Difference From Baseline
Time frame: baseline and 12 weeks
11-dehydrothromboxane B2 (TXB2): Difference From Baseline
Time frame: baseline and 12 weeks
Ecarin Clotting Time (ECT): Difference From Baseline
Time frame: baseline and 12 weeks
Activated Partial Thromboplastin Time (aPTT): Difference From Baseline
Time frame: baseline and 12 weeks
Trough Plasma Concentration of Dabigatran (BIBR 953)
Time frame: 12 weeks
Number of Participants With Increase of Aspartat-Aminotransferase (AST) to >2*Baseline
Time frame: 12 weeks
Number of Participants With Increase of Alkaline Phosphatase (AP) to >2*Baseline
Time frame: 12 weeks
Number of Participants With Increase of Bilirubin to >2*Baseline
Time frame: 12 weeks
Number of Participants With Increase of Alanine-Aminotransferase (ALT) to >2*Baseline
Time frame: 12 weeks
Severity of Adverse Events
Time frame: 12 weeks

Results and safety

Results posted to the registry on 10 Feb 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
BIBR 1048 50 mg b.i.d	58	56
BIBR 1048 50 mg b.i.d + ASA 81 mg q.d.	20	18
BIBR 1048 50 mg b.i.d + ASA 325 mg qd	27	26
BIBR 1048 150 mg b.i.d	99	91
BIBR 1048 150 mg b.i.d + ASA 81 mg qd	34	32
BIBR 1048 150 mg b.i.d + ASA 325 mg qd	33	32
BIBR 1048 300 mg b.i.d	98	90
BIBR 1048 300 mg b.i.d + ASA 81 mg qd	33	27
BIBR 1048 300 mg b.i.d + ASA 325 mg qd	30	24
Warfarin, Dosed to Target INR 2.0 to 3.0	70	68

Primary outcome: Number of Participants With Fatal or Life-threatening Major Bleeding Events

Time frame: 12 weeks. Number. Unit: Participants

Measure	BIBR 1048 50 mg b.i.d n = 59	BIBR 1048 50 mg b.i.d + ASA 81 mg q.d. n = 21	BIBR 1048 50 mg b.i.d + ASA 325 mg qd n = 27	BIBR 1048 150 mg b.i.d n = 100	BIBR 1048 150 mg b.i.d + ASA 81 mg qd n = 36	BIBR 1048 150 mg b.i.d + ASA 325 mg qd n = 33	BIBR 1048 300 mg b.i.d n = 105	BIBR 1048 300 mg b.i.d + ASA 81 mg qd n = 34	BIBR 1048 300 mg b.i.d + ASA 325 mg qd n = 30	Warfarin, Dosed to Target INR 2.0 to 3.0 n = 70
Value	0	0	0	0	0	0	0	1	3	0

Population analysed: All treated patients. No statistical comparisons were performed, due to the extremely small number of events.

Primary outcome: Number of Participants With Minor/Relevant Bleeding Events

Time frame: 12 weeks. Number. Unit: Participants

Measure	BIBR 1048 50 mg b.i.d n = 59	BIBR 1048 50 mg b.i.d + ASA 81 mg q.d. n = 21	BIBR 1048 50 mg b.i.d + ASA 325 mg qd n = 27	BIBR 1048 150 mg b.i.d n = 100	BIBR 1048 150 mg b.i.d + ASA 81 mg qd n = 36	BIBR 1048 150 mg b.i.d + ASA 325 mg qd n = 33	BIBR 1048 300 mg b.i.d n = 105	BIBR 1048 300 mg b.i.d + ASA 81 mg qd n = 34	BIBR 1048 300 mg b.i.d + ASA 325 mg qd n = 30	Warfarin, Dosed to Target INR 2.0 to 3.0 n = 70
Value	0	1	1	9	2	2	6	4	3	4

Population analysed: All treated patients. No statistical comparisons were performed, due to the small number of events per group

Primary outcome: Number of Participants With Minor/Nuisance Bleeding Events

Time frame: 12 weeks. Number. Unit: Participants

Measure	BIBR 1048 50 mg b.i.d n = 59	BIBR 1048 50 mg b.i.d + ASA 81 mg q.d. n = 21	BIBR 1048 50 mg b.i.d + ASA 325 mg qd n = 27	BIBR 1048 150 mg b.i.d n = 100	BIBR 1048 150 mg b.i.d + ASA 81 mg qd n = 36	BIBR 1048 150 mg b.i.d + ASA 325 mg qd n = 33	BIBR 1048 300 mg b.i.d n = 105	BIBR 1048 300 mg b.i.d + ASA 81 mg qd n = 34	BIBR 1048 300 mg b.i.d + ASA 325 mg qd n = 30	Warfarin, Dosed to Target INR 2.0 to 3.0 n = 70
Value	2	1	2	6	6	5	9	7	9	9

Population analysed: All treated patients. No statistical comparisons were performed, due to the small number of events per group

18 secondary outcomes are reported in the full results.

Adverse events

Time frame: 12 weeks. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
D50bid	5 of 59 (8.5%)	20 of 59 (33.9%)	Not reported
D50qd	0 of 1 (0%)	0 of 1 (0%)	Not reported
D50bid + ASA81qd	2 of 21 (9.5%)	9 of 21 (42.9%)	Not reported
D50bid + ASA325qd	1 of 27 (3.7%)	14 of 27 (51.9%)	Not reported
D150bid	10 of 100 (10%)	43 of 100 (43%)	Not reported
D150qd	0 of 3 (0%)	1 of 3 (33.3%)	Not reported
D150bid + ASA81qd	4 of 36 (11.1%)	19 of 36 (52.8%)	Not reported
D150qd + ASA81qd	0 of 1 (0%)	0 of 1 (0%)	Not reported
D150bid + ASA325qd	2 of 33 (6.1%)	15 of 33 (45.5%)	Not reported
D150qd + ASA325qd	0 of 1 (0%)	0 of 1 (0%)	Not reported
D300bid	3 of 105 (2.9%)	35 of 105 (33.3%)	Not reported
D300qd	0 of 3 (0%)	1 of 3 (33.3%)	Not reported
D300bid + ASA81qd	4 of 34 (11.8%)	20 of 34 (58.8%)	Not reported
D300qd + ASA81qd	0 of 2 (0%)	2 of 2 (100%)	Not reported
D300bid + ASA325qd	4 of 30 (13.3%)	18 of 30 (60%)	Not reported
D300qd + ASA325qd	0 of 1 (0%)	1 of 1 (100%)	Not reported
Warfarin	2 of 70 (2.9%)	22 of 70 (31.4%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related InfoLink provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Boehringer Ingelheim study chair

Boehringer Ingelheim

38 sites in 3 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing dabigatran with ASA, warfarin and dabigatran without ASA in people with Atrial Fibrillation, run by Boehringer Ingelheim at 38 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 May 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 38 sites in United States, Denmark, Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 10 Feb 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Fatal or Life-threatening Major Bleeding Events (time frame: 12 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01227629.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2014.