PETRO Stroke Prevention in Patients With AF by Treatment With Dabigatran, With and Without Aspirin, Compared to Warfarin
NCT ID: NCT01227629
Last Updated: 2014-05-05
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE2
502 participants
INTERVENTIONAL
2003-09-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
Study Groups
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dabigatran 50 mg twice daily (bid)
Dabigatran: one capsule in the morning and 1 capsule in the evening. Twice daily (bis in die = bid).
dabigatran without ASA
dose comparison
dabigatran 50 mg bid + 81 mg ASA qd
Dabigatran: one capsule in the morning and 1 capsule in the evening. Acetylsalicylic acid (ASA) once daily (quaque dies = qd) in the morning.
dabigatran with ASA
dose comparison in combination
dabigatran 50 mg bid + 325 mg ASA qd
Dabigatran: one capsule in the morning and 1 capsule in the evening. ASA in the morning
dabigatran with ASA
dose comparison in combination
dabigatran 150 mg bid
Dabigatran: one capsule in the morning and 1 capsule in the evening
dabigatran without ASA
dose comparison
dabigatran 150 mg bid + 81 mg ASA qd
Dabigatran: one capsule in the morning and 1 capsule in the evening. ASA in the morning
dabigatran with ASA
dose comparison in combination
dabigatran 150 mg bid + 325 mg ASA qd
Dabigatran: one capsule in the morning and 1 capsule in the evening. ASA in the morning
dabigatran with ASA
dose comparison in combination
dabigatran 300 mg bid
Dabigatran: one capsule in the morning and 1 capsule in the evening
dabigatran without ASA
dose comparison
dabigatran 300 mg bid + 81 mg ASA qd
Dabigatran: one capsule in the morning and 1 capsule in the evening. ASA in the morning
dabigatran with ASA
dose comparison in combination
dabigatran 300 mg bid + 325 mg ASA qd
Dabigatran: one capsule in the morning and 1 capsule in the evening. ASA in the morning
dabigatran with ASA
dose comparison in combination
warfarin
once daily, dosed to target International Normalised Ratio (INR) 2.0 to 3.0
warfarin
comparator
Interventions
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dabigatran with ASA
dose comparison in combination
dabigatran with ASA
dose comparison in combination
dabigatran with ASA
dose comparison in combination
dabigatran with ASA
dose comparison in combination
dabigatran with ASA
dose comparison in combination
dabigatran with ASA
dose comparison in combination
warfarin
comparator
dabigatran without ASA
dose comparison
dabigatran without ASA
dose comparison
dabigatran without ASA
dose comparison
Eligibility Criteria
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Inclusion Criteria
2. 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.
3. An additional risk factor for stroke, i.e. one or more of the following conditions/events:
1. hypertension (defined as systolic bloodpressure (SBP) \> 140 mmHg and/or diastolic bloodpressure (DBP) \> 90 mm Hg) requiring antihypertensive medical treatment.
2. diabetes mellitus (type I and II).
3. symptomatic heart failure or left ventricular dysfunction (ejection fraction (EF) \< 40%).
4. a previous ischemic stroke or transient ischemic attack.
5. age greater than 75 years.
6. history of coronary artery disease (by amendment 4)
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.
5. Age \> = 18 years at entry.
6. Written, informed consent.
Exclusion Criteria
2. Planned cardioversion.
3. Recent (=\< 1 month) myocardial infarction, stroke or transient ischemic attack (TIA), or patients who have received a coronary stent within the last 6 months.
4. Intolerance or contraindications to acetylsalicylic acid (ASA).
5. Any contraindication to anticoagulant therapy.
6. Major bleeding within the last 6 months (other than gastrointestinal (GI) hemorrhage).
7. Severe renal impairment (estimated glomerular filtration rate (GFR) =\< 30 mL/min).
8. Uncontrolled hypertension (SBP \> 180 mmHg and/or DBP \> 100 mmHg).
9. 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.
10. Women who are pregnant or of childbearing potential who refuses to use a medically acceptable form of contraception throughout the study.
11. Patients who have received an investigational drug within the last 30 days.
12. 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.
13. Patients considered unreliable by the investigator.
14. Another indication for anticoagulant treatment.
15. Patients suffering from anemia.
16. Patients suffering from thrombocytopenia.
17. Any other condition which, in the discretion of the investigator, would not allow safe participation in the study.
18. Concomitant treatment with antiplatelet agents other than ASA.
19. Recent malignancy or radiation therapy (=\< 6 month).
18 Years
ALL
No
Sponsors
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Boehringer Ingelheim
INDUSTRY
Responsible Party
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Boehringer Ingelheim
Principal Investigators
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Boehringer Ingelheim
Role: STUDY_CHAIR
Boehringer Ingelheim
Locations
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1160.20.10010
Fayetteville, Arkansas, United States
1160.20.10003 La Mesa Cardiac
La Mesa, California, United States
1160.20.10006 The Ford Research Institute, PA
Pensacola, Florida, United States
1160.20.10004
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
Malmo, , 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
Countries
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Other Identifiers
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PETRO trial
Identifier Type: OTHER
Identifier Source: secondary_id
1160.20
Identifier Type: -
Identifier Source: org_study_id
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