💬In plain words
What the trial is, and whether it could suit you
A single-center, open-label, randomized comparative study of two treatment strategies in patients with intermediate-high-risk acute pulmonary embolism (PE). Patients will be randomized in a 1:1 ratio to standard anticoagulant therapy or standard catheter-directed thrombolysis (SСDT) with a low dose of alteplase, followed by evaluation of short- and long-term efficacy and safety in each group
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
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
💊
What it tests
- Standard Catheter-Directed Low Dose Thrombolysis
- Standard Anticoagulation
Almazov National Medical Research Centre
Saint Petersburg, Russia
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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