Arrhythmias and conduction disturbanceDabigatran With or Without Concomitant Aspirin Compared With Warfarin Alone in Patients With Nonvalvular Atrial Fibrillation (PETRO Study)
Section snippets
Methods
This study was conducted in 53 centers in Denmark, the Netherlands, Sweden, and the United States. The protocol was developed by the Steering Committee of the Prevention of Embolic and Thrombotic Events in Patients with Persistent AF (PETRO) study group. An independent adjudication committee blinded to treatment evaluated all bleeding events. An independent data and safety monitoring board monitored the study for safety. Boehringer Ingelheim (Biberach, Germany) sponsored the study and was
Results
Of 502 patients randomized, 411 (81.9%) were men, with 192 (38.2%) having permanent AF, 195 (38.8%) persistent AF, and 115 (22.9%) paroxysmal AF. The median duration of AF was 4 years (range 0.05 to 30). Mean ages were 70.9 ± 7.9 years in patients with CAD (n = 306) and 68.0 ± 8.8 years in those without CAD. The baseline characteristics were balanced among the 10 randomized treatment groups (Table 1). Patients had a median of 3 risk factors for stroke.
The mean rate of compliance with dabigatran
Discussion
This phase 2 trial of several fixed doses of a direct thrombin inhibitor with and without aspirin compared with warfarin alone in AF established a dose response for bleeding and an upper limit of tolerability (300 mg twice daily plus aspirin) based on the frequency of major and clinically significant bleeding events. As anticipated, the frequency of thromboembolic events was too low to reach conclusions, but the only 2 strokes in this 12-week trial occurred in patients receiving the lowest dose
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Cited by (0)
Boehringer Ingelheim Pharmaceuticals, Biberach, Germany, is the sponsor of this study and has provided a research grant. The members and structure of the PETRO study group are given in the Appendix at the end of this article.