EudraCT No.: 2015-001830-12
PEITHO-2 is a prospective, multicenter, phase IV, single-armed (management) trial that has been designed to address clinically relevant unresolved issues in the management of patients with intermediate-risk pulmonary embolism (PE). Risk stratification of PE is based on validated imaging (echocardiographic or CT angiographic) and laboratory biomarker (circulating levels of cardiac troponins and natriuretic peptides) parameters and their combinations, as recommended by the 2014 ESC guidelines. The primary objective of the study is to determine whether treatment of acute intermediate-risk PE (as defined by the inclusion and exclusion criteria) with parenteral anticoagulation for at least 72 hours after diagnosis, followed by dabigatran over 6 months, is effective and safe. The secondary objective is to assess the recovery of right ventricular function over the first days of treatment, and to evaluate its importance for the 6-month prognosis of patients with intermediate-risk PE. Approximately 700 patients with acute symptomatic intermediate-risk PE will be included in 40 hospitals across Europe. The study is recruiting patients since January 2016.
PEITHO-2 Steering Committee and National Coordinators: Stavros Konstantinides, Germany (PI); Guy Meyer, France (Co-PI); Jan Beyer-Westendorf, Germany; Michael Christ, Germany; Daniel Dürschmied, Germany; Klaus Empen, Germany; Nazzareno Galiè, Italy; Matthias Held, Germany; Menno Huisman, The Netherlands; David Jiménez, Spain; Frederikus Klok, The Netherlands; Matija Kozak, Slovenia; Irene Lang, Austria; Nicolas Meneveau, France; Piotr Pruszczyk, Poland; Sebastian Schellong, Germany; Branislav Stefanovic, Serbia; Adam Torbicki, Poland; Franck Verschuren, Belgium