Status:
RECRUITING
Evaluation of the Standard Catheter-directed Thrombolysis Effectiveness in Intermediate-High-Risk Pulmonary Embolism Patients
Lead Sponsor:
Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health
Conditions:
Pulmonary Embolism Acute
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 10 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2027
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT06487052
Start Date
January 10 2024
End Date
December 1 2027
Last Update
July 5 2024
Active Locations (1)
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1
Almazov National Medical Research Centre
Saint Petersburg, Russia, 197341