Project Details
Projekt
Pulmonary Embolism International Thrombolysis Study (PEITHO) Study 3: A reduced dose of intravenous thrombolytic treatment for patients with intermediate high-risk acute pulmonary embolism
Applicant
Professor Dr. Stavros Konstantinides
Subject Area
Cardiology, Angiology
Term
since 2020
Project identifier
Deutsche Forschungsgemeinschaft (DFG) - Project number 401833708
Acute pulmonary embolism (PE), a clinical manifestation of venous thromboembolism, is the third most frequent acute cardiovascular syndrome and a major threat for the life and well-being of a large number of individuals worldwide. Up to 30% of patients die in the acute phase of PE. Standard-dose systemic, intravenously administered thrombolysis is the prototype of reperfusion therapy for acute PE and it can result in prompt relief of obstruction of the pulmonary arteries and rapid haemodynamic improvement. At present however, this type of therapy is recommended only for the small group of unstable patients who present with cardiogenic shock, due to its significant bleeding risks. The present randomised placebo-controlled double-blind multicentre multinational trial, PEITHO-3, will investigate the efficacy and safety of reduced-dose thrombolysis in the larger group of normotensive patients with intermediate-risk PE, i.e. with clinical, imaging (echocardiographic, computed tomographic) and laboratory findings indicating acute right ventricular dysfunction. We hypothesize that reduced-dose (up to 50 mg of alteplase) thrombolytic treatment on top of heparin anticoagulation will result in significant reduction in all-cause mortality, haemodynamic collapse, or recurrent PE compared to heparin anticoagulation alone. We further hypothesize that this reduction will be obtained without a significant increase in intracranial or other life-threatening bleeding compared to heparin alone, as was the case with full-dose thrombolysis in previous trials. It is expected that PEITHO-3 will advance current strategies of risk-adjusted PE management, and that it will help to modify the recommendations of international guidelines, making reperfusion treatment a safer, potentially lifesaving option for a substantial proportion of patients with acute PE. As of 30 April 2025, 634 patients were enrolled in PEITHO-3 (154 thereof in Germany and Austria). Following a predefined interim analysis, the sample size was increased from 650 to 800 patients. Last-patient-in for the adapted sample size is expected for June 2026.
DFG Programme
Clinical Trials
