PETRO

Dabigatran with or without concomitant aspirin compared with warfarin alone in patients with non-valvular atrial fibrillation (2007)

Condition

Non-valvular AF

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Objective

To determine the safety and efficacy of dabigatran with or without concomitant treatment with ASA in patients with AF when compared to warfarin

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Trial design

Randomized, parallel group, double-blind (for dabigatran), open-label (for ASA and warfarin), phase II study
Active treatment: dabigatran 50 mg (n=107), 150 mg (n=169) or 300 mg (n=169) p.o. twice daily in combination with no ASA, 81 mg or 325 mg ASA once daily, for 12 weeks
Control treatment: warfarin (INR 2.0–3.0) (n=70)

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Endpoints

Primary endpoint: incidence of bleeding events
Secondary endpoints: change from baseline in plasma concentrations of D-dimer; a composite clinical endpoint of any thromboembolic or cardiac event, other major adverse cardiac events and all-cause mortality; the incidence of all adverse events

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Trial participants

502 patients with non-valvular atrial fibrillation with/without CAD + ≥1 risk factor for CV complications (hypertension requiring medical treatment, diabetes mellitus [type 1 or 2], symptomatic heart failure or left ventricular dysfunction [EF <40%], previous stroke or TIA, or age >75 years)

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Results

Primary outcome: The rate of major or clinically relevant non-major bleeding events increased with the dose of dabigatran
Secondary outcomes: After 12 weeks treatment the change of D-Dimervalue compared to baseline was +10 in patients given 50 mg dabigatran twice daily, +2 in patients given 150 mg dabigatran twice daily, ±0 in patients given 300 mg twice daily and –1 in patients given warfarin. With increasing dose of dabigatran adverse events leading to treatment discontinuation were more frequent (4.8% in 50 mg dabigatran twice daily, 5.3% in 150 mg dabigatran twice daily, and 8.9% in 300 mg dabigatran twice daily) and did not occur in patients given warfarin

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Summary

Efficacy: All thromboembolic events occurred in patients treated with low dose of dabigatran
Safety: With increasing dose of dabigatran bleeding events and adverse events leading to treatment discontinuation were more frequent

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Reference

Ezekowitz MD, Reilly PA, Nehmiz G, Simmers TA, Nagarakanti R, Parcham-Azad K, Pedersen KE, Lionetti DA, Stangier J, Wallentin L. Dabigatran with or without concomitant aspirin compared with warfarin alone in patients with non-valvular atrial fibrillation (PETRO Study). Am J Cardiol 2007;100:1419-426

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Corresponding author

Michael D. Ezekowitz, Lankenau Institute for Medical Research and The Heart Center, Wynnewood, Pennsylvania, e-mail: ezekowitzm@mlhs.org

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