A prospective, randomized, double-blind, placebo-controlled, international, multicenter, 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 and laboratory evidence of right ventricular dysfunction. - PEITHO
- Conditions
- Patients with pulmonary embolism of moderate severityMedDRA version: 8.1Level: PTClassification code 10014521Term: <Manually entered code. Term in E.1.1>
- Registration Number
- EUCTR2006-005328-18-GR
- Lead Sponsor
- ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 1000
•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.
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)
•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 Main Objective: To demonstrate the clinical benefits of tenecteplase over placebo in normotensive patients with acute pulmonary embolism and with echographic (or spiral computed tomography) and laboratory evidence of right ventricular dysfunction.;Secondary Objective: To assess the safety after administration of tenecteplase in normotensive patients with acute pulmonary embolism and with echographic (or spiral computed tomography) and laboratory evidence of right ventricular dysfunction;Primary end point(s): The primary end point of this study is:<br>•Death or haemodynamic collapse within 7 days<br>The secondary endpoints of this study are:<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.<br>
- Secondary Outcome Measures
Name Time Method