PEITHO Pulmonary Embolism THrOmbolysis Study Thrombolysis in Acute Pulmonary Embolism

Phase 1

• Conditions: Patients with intermediate severity pulmonary embolism; MedDRA version: 20.0 Level: LLT Classification code 10014521 Term: Embolism pulmonary System Organ Class: 100000004855; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2006-005328-18-PT
• 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: 2007-09-10
• Last Update Posted: 16 December 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 1000

Inclusion Criteria

- age 18 years or older;
- acute PE (first symptoms occurring 15 days or less before randomisation)
- 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 1000
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 600

Exclusion Criteria

- Haemodynamic collapse
- Known significant bleeding risk
- Administration of thrombolytic agents within the previous 4 days
- Uncontrolled hypertension defined as systolic BP >180 mm Hg and/or diastolic BP >110 mm Hg at randomisation
- 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)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified