A prospective, randomized, double-blind, placebo-controlled, international, multicenter, parallel-group comparison trial evaluating the efficacy and safety of single i.v. bolus tenecteplase as compared with standard treatment in normotensive patients with acute pulmonary embolism and with echographic and laboratory evidence of right ventricular dysfunction. - PEITHO

Phase 1

• Conditions: Patients suffering from acute pulmonary embolism; MedDRA version: 13.1Level: LLTClassification code 10014521Term: Embolism pulmonarySystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders

• Registration Number: EUCTR2006-005328-18-AT
• Lead Sponsor: ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-01-14
• Last Update Posted: 8 August 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

- Age 18 years or older

- acute PE (first symptoms occurring 15 days or less before randomization) 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

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