Phase 2
Completed N=502
PETRO Stroke Prevention in Patients With AF by Treatment With Dabigatran, With and Without Aspirin, Compared to Warfarin
Source: ClinicalTrials.gov NCT01227629 ↗Enrolled (actual)
502
Serious AEs
7.0%
Results posted
Feb 2011
Primary outcomePrimary: Number of Participants With Fatal or Life-threatening Major Bleeding Events — 0; 0; 0; 0 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Fatal or Life-threatening Major Bleeding Events |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Number of Participants With Minor/Relevant Bleeding Events |
0; 1; 1; 9; 2; 2 | — |
| PRIMARY Number of Participants With Minor/Nuisance Bleeding Events |
2; 1; 2; 6; 6; 5 | — |
| SECONDARY Number of Participants With Thromboembolic Events: Composite Endpoint |
1; 2; 1; 0; 0; 0 | — |
| SECONDARY Number of Participants With Thromboembolic Events: Ischemic Stroke |
58; 19; 27; 99; 34; 33 | — |
| SECONDARY Thromboembolic Events: Number of Participants With Transient Ischemic Attack |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Thromboembolic Events: Number of Participants With Systemic Thromboembolism |
1; 1; 0; 0; 0; 0 | — |
| SECONDARY Thromboembolic Events: Number of Participants With Myocardial Infarction |
58; 20; 27; 99; 34; 33 | — |
| SECONDARY Thromboembolic Events: Number of Participants With Other Major Cardiac Events |
0; 1; 1; 0; 0; 0 | — |
| SECONDARY Thromboembolic Events: Number of Participants Who Died |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY D-dimer: Difference From Baseline |
22.3; 12.3; 50.2; 8.1; 29.1; 8.6 | 0.0357 sig |
| SECONDARY Soluble Fibrin: Difference From Baseline |
3.2; 0.9; 1.2; 0.3; -2.0; -1.3 | 0.26711 |
| SECONDARY 11-dehydrothromboxane B2 (TXB2): Difference From Baseline |
596.5; -1816.8; -2779.8; 922.0; -1988.6; -1125.9 | — |
| SECONDARY Ecarin Clotting Time (ECT): Difference From Baseline |
9.7; 12.0; 12.0; 31.9; 42.5; 32.7 | — |
| SECONDARY Activated Partial Thromboplastin Time (aPTT): Difference From Baseline |
6.4; 8.3; 8.8; 13.5; 24.9; 14.5 | — |
| SECONDARY Trough Plasma Concentration of Dabigatran (BIBR 953) |
29.1; 30.4; 31.8; 82.8; 103.2; 90.1 | — |
| SECONDARY Number of Participants With Increase of Aspartat-Aminotransferase (AST) to >2*Baseline |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Number of Participants With Increase of Alkaline Phosphatase (AP) to >2*Baseline |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Number of Participants With Increase of Bilirubin to >2*Baseline |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Number of Participants With Increase of Alanine-Aminotransferase (ALT) to >2*Baseline |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Severity of Adverse Events |
24; 0; 9; 16; 54; 1 | — |
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) = 18 years at entry.
- Written, informed consent.
Exclusion criteria
- Valvular heart disease.
- Planned cardioversion.
- Recent (= 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).
Data sourced from ClinicalTrials.gov (NCT01227629). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.