Status:
COMPLETED
PEITHO Pulmonary Embolism Thrombolysis Study
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Collaborating Sponsors:
German Federal Ministry of Education and Research
Boehringer Ingelheim
Conditions:
Pulmonary Embolism
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 ha...
Detailed Description
A prospective, randomized, double-blind, placebo-controlled, international, multicentre, parallel-group comparison trial evaluating the efficacy and safety of single i.v. bolus tenecteplase plus stand...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
November 16 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2014
Estimated Enrollment :
1005 Patients enrolled
Trial Details
Trial ID
NCT00639743
Start Date
November 16 2007
End Date
November 1 2014
Last Update
November 9 2020
Active Locations (12)
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1
Vienna Medical University
Vienna, Austria
2
Hospital St. Luc
Brussels, Belgium
3
CHU Hopital Jean Minjoz
Besançon, France
4
Universistaetsklinik
Freiburg im Breisgau, Germany