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Reduced-dose intravenous thrombolysis for acute intermediate high-risk pulmonary embolism (PEITHO-3)

Head of Study: Univ.-Prof. Dr. Stavros Konstantinides; Univ.-Prof. Dr. Olivier Sanchez

EudraCT-Nr: 2018-000816-96

ClinicalTrials.gov Identifier: NCT04430569

https://clinicaltrials.gov/ct2/show/NCT04430569

Summary

Intermediate high-risk pulmonary embolism (PE) is characterised by right ventricular (RV) dysfunction and elevated circulating cardiac troponin levels despite apparent haemodynamic stability at presentation. In these patients, full-dose systemic thrombolysis reduced the risk of haemodynamic decompensation or death but increased the risk of life-threatening bleeding. Reduced-dose thrombolysis may be capable of improving safety while maintaining reperfusion efficacy. The Pulmonary Embolism International Trial (PEITHO)-3 study (EudraCT 2018-000816-96) is a randomised, placebo-controlled, double-blind, multicentre, multinational trial with long-term follow-up. We will compare the efficacy and safety of a reduced-dose alteplase regimen with standard heparin anticoagulation. Patients with intermediate high-risk PE will also fulfil at least one clinical criterion of severity: systolic blood pressure ≤ 110 mmHg, respiratory rate >20 breaths/min, or history of heart failure. The primary efficacy outcome is the composite of all-cause death, haemodynamic decompensation or PE recurrence within 30 days of randomisation. Key secondary outcomes, to be included in hierarchical analysis, are fatal or GUSTO severe or life-threatening bleeding; net clinical benefit (primary efficacy outcome plus severe or life-threatening bleeding); and all-cause death, all within 30 days. All outcomes will be adjudicated by an independent committee. Further outcomes include PE-related death, haemodynamic decompensation, or stroke within 30 days; dyspnoea, functional limitation or RV dysfunction at 6 months and 2 years; and utilisation of healthcare resources within 30 days and 2 years. The study is planned to enrol 650 patients. The results are expected to have a major impact on risk-adjusted treatment of acute PE and inform guideline recommendations.

Further information on the study design can be found here (Pdf-file, 604,5 KB)

 

 

Study Type

Interventional

Study Design

Randomized, placebo-controlled, multicenter and multinational double-blind study with long-term follow-up

Official Title

Reduced-dose intravenous thrombolysis for acute intermediate high-risk pulmonary embolism (Peitho-3)

Sponsor

Assistance publique – Hôpitaux de Paris (AP-HP)

Status

Recruiting

Steering Committee

Stavros Konstantinides, Olivier Sanchez, Walter Ageno, Harald Binder, Melanie Ferreira, Menno Huisman, David Jimenez, Sandrine Katsahian,Matija Kozak, Mareike Lankeit, Nicolas Meneveau, Piotr Pruszczyk, Antoniu Petris, Marc Righini,Branislav Stefanovic, Peter Verhamme, Eric Vicaut, Kerstin de Wit

Newsletter

PEITHO-3 Newsletter Nr. 2 (Pdf-file, 249,0 KB)

PEITHO-3 Newsletter Nr. 1 (Pdf-file, 232,5 KB)