Evaluation of the Standard Catheter-Directed Thrombolysis Effectiveness in Intermediate-High-Risk Pulmonary Embolism Patients

What this Trial Is About

Researchers are evaluating two treatment strategies for patients with intermediate-high-risk acute pulmonary embolism (PE) in a randomized, open-label study. The goal is to compare the short- and long-term effects and safety of standard anticoagulant therapy versus catheter-directed thrombolysis using a low dose of alteplase. This study is conducted at a single center and aims to provide insights into which approach better manages the condition. Participants will be randomly assigned to one of two groups. One group receives standard anticoagulant therapy with unfractionated heparin (UFH) for up to 48 hours, then switches to oral anticoagulants. The other group undergoes catheter-directed thrombolysis, where alteplase is infused locally via a catheter over 9 hours in doses of 10 mg or 20 mg depending on the lesion location, combined with UFH targeting a specific blood clotting time, followed by continued UFH for 24 hours and then oral anticoagulants. During the study, participants will undergo assessments including imaging to measure right and left ventricle size ratios within 48 hours, evaluation of clot reduction, and monitoring for complications such as bleeding and heart or lung function issues. Follow-up includes checking mortality and post-embolism syndrome up to 180 days. Researchers will carefully monitor safety and treatment responses throughout the study, which is expected to last until late 2027.

Evaluation of the Standard Catheter-directed Thrombolysis Effectiveness in Intermediate-High-Risk Pulmonary Embolism Patients