PEITHO Pulmonary Embolism Thrombolysis Study

• Status: Completed
• Trial end date: 2014-11-01
• Target enrollment: 0
• Participant gender: All

Summary

Heparin is the reference therapy for most patients with pulmonary embolism. Some patients with sub-massive pulmonary embolism defined by normal blood pressure and dysfunction of the right ventricle have a higher mortality risk. It has been suggested that thrombolytic treatment, a drug that dissolves blood clots more rapidly, may reduce the mortality in those patients. The studies reported to date were unable to confirm or refute this hypothesis because the number of patients included in those studies is too low. The aim of the study is to compare thrombolytic treatment with heparin (which is the reference therapy for pulmonary embolism) in a large group of patients with sub-massive pulmonary embolism.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Assistance Publique - Hôpitaux de Paris
• Collaborators: Boehringer Ingelheim; German Federal Ministry of Education and Research
• Treatments: Tenecteplase; Tissue Plasminogen Activator

Criteria

Inclusion Criteria:

• Age 18 years or older

• Acute PE (first symptoms occurring 15 days or less before randomisation) confirmed by lung scan, or a positive spiral computed tomogram, or a positive pulmonary angiogram

• Right ventricular dysfunction confirmed by echocardiography or spiral computed tomography of the chest and a positive troponin I or T test

Exclusion criteria:

• Haemodynamic collapse at presentation as defined above

• Known significant bleeding risk

• Administration of thrombolytic agents within the previous 4 days

• Vena cava filter insertion or pulmonary thrombectomy within the previous 4 days

• Uncontrolled hypertension defined as systolic BP >180 mm Hg and/or diastolic BP >110 mm Hg at randomisation

• Treatment with an investigational drug under another study protocol in the previous 7 days or greater, according to local requirements

• Previous enrolment in this study

• Known hypersensitivity to tenecteplase, alteplase, unfractionated heparin, or to any of the excipients

• Pregnancy, lactation or parturition within the previous 30 days. Women of childbearing age must have a negative pregnancy test or use a medically accepted method of birth control

• Known coagulation disorder (including vitamin K antagonists)

• Any other condition that the investigator feels would place the patient at increased risk if the investigational therapy is initiated