Pulmonary Embolism International THrOmbolysis Study-3

Summary

In this study, we will assess the efficacy and safety of a reduced dose of thrombolytic therapy given in addition to low-molecular-weight heparin in patients with intermediate-high-risk acute pulmonary embolism. Half of participants will receive thrombolytic treatment, while the other half will receive a placebo.

Conditions

• Pulmonary Embolism

Interventions

DRUG

Alteplase

Alteplase single intravenous infusion of 0.6 mg/kg of estimated bodyweight with a maximum of 50 mg given over 15 minutes.

DRUG

Placebo

Placebo single intravenous infusion of 0.6 mg/kg of estimated bodyweight with a maximum of 50 mg given over 15 minutes.

Sponsors & Collaborators

• Johannes Gutenberg University Mainz

  collaborator OTHER

• Life Sciences Research Partners (D Collen Research Foundation)

  collaborator UNKNOWN

• Canadian Institutes of Health Research (CIHR)

  collaborator OTHER_GOV

• Instituto de Salud Carlos III

  collaborator OTHER_GOV

• International Network of VENous Thromboembolism Clinical Research Networks

  collaborator UNKNOWN

• Boehringer Ingelheim

  collaborator INDUSTRY

• Assistance Publique - Hôpitaux de Paris

  lead OTHER

Principal Investigators

• Olivier SANCHEZ, MD · Assistance Publique - Hôpitaux de Paris

• Stavros Konstantinides, MD · University Medical Center Mainz

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-08-04

Primary Completion

2026-09-30

Completion

2028-08-31

Countries

• Austria
• Belgium
• Canada
• France
• Germany
• Italy
• Netherlands
• Poland
• Portugal
• Romania
• Serbia
• Slovenia
• Spain
• Switzerland

Study Locations