PEITHO
The Pulmonary Embolism THrOmbolysis (PEITHO) study is a collaborative effort of physicians involved in the treatment of patients suffering from acute pulmonary embolism. It was initiated and is sponsored (as an Investigator-Initiated Study) by the Clinical Research Delegation at Assistance Publique-Hôpitaux de Paris (AP-HP), which is a non-profit organisation.
The primary objective of the PEITHO study is to demonstrate the clinical benefits of thrombolysis with tenecteplase over placebo in normotensive patients with acute pulmonary embolism and right ventricular dysfunction.
The secondary objective is to assess the safety after administration of tenecteplase in normotensive patients with acute pulmonary embolism and with echocardiographic and laboratory evidence of right ventricular dysfunction.
The PEITHO study is a prospective, randomised, double-blind, placebo-controlled, international, multi-centre, parallel-group comparison trial evaluating the efficacy and safety of single IV bolus tenecteplase plus standard anticoagulation therapy compared with standard anticoagulation therapy in normotensive patients with acute pulmonary embolism and right ventricular dysfunction, based on echocardiographic and laboratory evidence.
The primary endpoint is a composite of all-cause mortality or haemodynamic collapse within 7 days of randomisation.
Secondary endpoints include death within 7 days, haemodynamic collapse within 7 days, confirmed symptomatic pulmonary embolism recurrence within 7 days, and death within 30 days.
Approximately 1000 patients were enrolled between 2007 and 2012.
Results can be found in Meyer G, et al. Fibrinolysis for patients with intermediate-risk pulmonary embolism. N Engl J Med. 2014 Apr 10;370(15):1402-1411.
PEITHO: Study design
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Reference:
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The PEITHO Steering Committee. Single-bolus tenecteplase plus heparin compared with heparin alone for normotensive patients with acute pulmonary embolism who have evidence of right ventricular dysfunction and myocardial injury: rationale and design of the Pulmonary Embolism Thrombolysis (PEITHO) trial. Am Heart J 2012;163:33-38(e31).