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

NCT01227629 | Completed Phase 2 Results

• 2 other identifiers: 1160.20PETRO trial
• Study Type: interventional
• Target: 502
• Locations: 3 countries
• Sites: 38

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.

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (3)

• 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 (18)

• Number of Participants With Thromboembolic Events: Composite Endpoint

  12 weeks

• Number of Participants With Thromboembolic Events: Ischemic Stroke

  12 weeks

• Thromboembolic Events: Number of Participants With Transient Ischemic Attack

  12 weeks

• Thromboembolic Events: Number of Participants With Systemic Thromboembolism

  12 weeks

• Thromboembolic Events: Number of Participants With Myocardial Infarction

  12 weeks

Study Arms (10)

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

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

Interventions

dabigatran with ASA DRUG

dose comparison in combination

dabigatran 50 mg bid + 81 mg ASA qd

warfarin DRUG

comparator

warfarin

dabigatran without ASA DRUG

dose comparison

dabigatran 50 mg twice daily (bid)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• Age \> = 18 years at entry.
• Written, informed consent.

You may not qualify if:

• 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).
• 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.

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (38)

1160.20.10010

Fayetteville, Arkansas, United States

Location

1160.20.10003 La Mesa Cardiac

La Mesa, California, United States

Location

1160.20.10006 The Ford Research Institute, PA

Pensacola, Florida, United States

Location

1160.20.10004

Port Charlotte, Florida, United States

Location

1160.20.10002

St. Petersburg, Florida, United States

Location

1160.20.10015

Baltimore, Maryland, United States

Location

1160.20.10008

Westminister, Maryland, United States

Location

1160.20.10012

Pittsfield, Massachusetts, United States

Location

1160.20.10007

Troy, Michigan, United States

Location

1160.20.10014

Hawthorne, New York, United States

Location

1160.20.10013

New Hyde Park, New York, United States

Location

1160.20.10009

North Durham, North Carolina, United States

Location

1160.20.10001

Philadelphia, Pennsylvania, United States

Location

1160.20.10005

Germantown, Tennessee, United States

Location

1160.20.45010

Aalborg, Denmark

Location

1160.20.45005 Aarhus Sygehus

Aarhus C, Denmark

Location

1160.20.45007 Medicinsk afdeling

Brædstrup, Denmark

Location

1160.20.45003 Forskningscentret plan 3

Elsinore, Denmark

Location

1160.20.45011 Medicinsk afd.

Esbjerg, Denmark

Location

1160.20.45012 Afdeling B3

Frederikssund, Denmark

Location

1160.20.45004 Herlev Hospital

Herlev, Denmark

Location

1160.20.45009 Medicinsk amb. B8

Holbæk, Denmark

Location

1160.20.45002 Kardiologisk afdeling

Hvidovre, Denmark

Location

1160.20.45014 Hjertemedicinsk afd.

Køge, Denmark

Location

1160.20.45001 Kardiologisk Laboratorium

Odense, Denmark

Location

1160.20.45013 Kardiologisk afd.

Roskilde, Denmark

Location

1160.20.45006 Medicinsk afdeling

Svendborg, Denmark

Location

1160.20.46013 HIA, Mälarsjukhuset

Eskilstuna, Sweden

Location

1160.20.46007 Falu Lasarett

Falun, Sweden

Location

1160.20.46005 Ryhovs Länssjukhus

Jönköping, Sweden

Location

1160.20.46010 Länssjukhuset Kalmar

Kalmar, Sweden

Location

1160.20.46009 Universitetssjukhuset MAS

Malmo, Sweden

Location

1160.20.46008 Vrinnevisjukhuset

Norrköping, Sweden

Location

1160.20.46004 Universitetssjukhuset

Örebro, Sweden

Location

1160.20.46002 Södersjukhuset

Stockholm, Sweden

Location

1160.20.46011 Arytmienheten, Med klin

Stockholm, Sweden

Location

1160.20.46006 Norrlands Universitetssjukhus

Umeå, Sweden

Location

1160.20.46003 Centrallasarettet

Västerås, Sweden

Location

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Dabigatran; Warfarin

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; 4-Hydroxycoumarins; Coumarins; Benzopyrans; Pyrans

Results Point of Contact

• Title: Boehringer Ingelheim Call Center
• Organization: Boehringer Ingelheim Pharmaceuticals

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Study Officials

• Boehringer Ingelheim

  Boehringer Ingelheim

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: October 22, 2010
• First Posted: October 25, 2010
• Study Start: September 1, 2003
• Primary Completion: November 1, 2004
• Last Updated: May 5, 2014
• Results First Posted: February 10, 2011

Record last verified: 2014-04

Locations

US (14); DK (13); SE (11)