Trial of a new thrombolytic (clot busting) agent in patients with acute pulmonary embolism who have stable blood pressure on admission to the hospital.

Phase 1

• Conditions: Patients suffering from acute pulmonary embolism; MedDRA version: 14.1Level: LLTClassification code 10014521Term: Embolism pulmonarySystem Organ Class: 100000004855; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2006-005328-18-DE
• 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: 2007-06-18
• 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 750
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 250

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