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 standard anticoagulation as compared with standard anticoagulation in normotensive patients with acute pulmonary embolism and with echocardiographic (or spiral CT) and laboratory evidence of right ventricular dysfunction. - PEITHO
- Conditions
- Patients suffered from acut pulmonary embolism.
- Registration Number
- EUCTR2006-005328-18-HU
- Lead Sponsor
- Assistance Publique - Hôpitaux de Paris (AP-HP)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 1000
Patients suffering from acute pulmonary embolism (first symptoms occurring within 15 days) confirmed by lung scanning or a positive spiral computed tomogram, or a positive pulmonary angiogram, presenting with right ventricular dysfunction on echocardiography (or spiral CT) and tested troponin I or T positive.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
•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 and platelet count < 100 000/mm3)
•Any other condition that the investigator feels would place the patient at increased risk if the investigational therapy is initiated.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary end point(s): •Clinical composite endpoint of all-cause mortality or haemodynamic collapse within 7 days<br><br>Secondary end points:<br>•Death within 7 days<br>•Haemodynamic collapse within 7 days<br>•Confirmed symptomatic pulmonary embolism recurrence within 7 days<br>•Death within 30 days;Main Objective: The primary objective is to demonstrate the clinical benefits of tenecteplase over placebo in normotensive patients with acute pulmonary embolism and right ventricular dysfunction.;Secondary Objective: The secondary objective is to assess the safety after administration of tenecteplase in normotensive patients with acute pulmonary embolism and with echocardiographic (or spiral CT) and laboratory evidence of right ventricular dysfunction.
- Secondary Outcome Measures
Name Time Method