Evaluating catheter-directed thrombolysis for pulmonary embolism patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study compares the effectiveness of standard anticoagulant therapy to standard catheter-directed thrombolysis using a low dose of alteplase in patients with intermediate-high-risk acute pulmonary embolism. It is a single-center, open-label, randomized trial where participants will be assigned to one of the two treatment strategies in a 1:1 ratio. The study aims to assess both short- and long-term efficacy and safety outcomes for each treatment approach.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age \> 18 years
* Computed tomography angiography (CTA) - verified proximal (pulmonary trunk and/or main and/or lobar branches of the pulmonary artery) PE and symptom onset \< 14 days prior
* Intermediate-high risk PE with a RV dysfunction (RV/LV diameter ratio \>1 on TTE or CTA) and an elevated biomarker (hs-troponin or NT-proBNP) level
* Signed informed consent

Exclusion Criteria:

* High-risk pulmonary embolism
* Thrombus in the heart chambers on TTE
* Absolute contraindications for the use of thrombolytic therapy: history of hemorrhagic stroke or stroke of unknown etiology; ischemic stroke or transient ischemic attack within the last 6 months; extensive bleeding currently or within the previous 6 months, hemorrhagic diathesis; diseases of the central nervous system (including neoplasms, aneurysm, surgery on the brain or spinal cord); intracranial (including subarachnoid) hemorrhage currently or in history, suspicion of hemorrhagic stroke; severe uncontrolled arterial hypertension; major surgery or major trauma within the previous 3 months, recent traumatic brain injury; labor during the previous 10 days; severe liver diseases, including liver failure, cirrhosis, portal hypertension (including esophageal varices) and active hepatitis; bacterial endocarditis, pericarditis; acute pancreatitis; confirmed peptic ulcer of the stomach or duodenum within the last 3 months; arterial aneurysms, congenital anomalies of arteries/veins;
* Haemoglobin level \< 70 g/L, platelet count ≤ 100 x 109
* Allergic to alteplase or UFH or contrast allergy
* Pregnant or breastfeeding
* Clinically significant malignancies

Where it's running

• Almazov National Medical Research Centre
  Saint Petersburg, Russia Recruiting

Study contacts

• Study coordinator: Olga Moiseeva
• Email: moiseeva_om@almazovcentre.ru
• Phone: +79213068249

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.