NCT06487052 Evaluation of the Standard Catheter-directed Thrombolysis Effectiveness in Intermediate-High-Risk Pulmonary Embolism Patients
| NCT ID | NCT06487052 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health |
| Condition | Pulmonary Embolism Acute |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2024-01-10 |
| Primary Completion | 2027-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 100 participants in total. It began in 2024-01-10 with a primary completion date of 2027-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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
Eligibility Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06487052 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Pulmonary Embolism Acute. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06487052 currently recruiting?
Yes, NCT06487052 is actively recruiting participants. Contact the research team at moiseeva_om@almazovcentre.ru for enrollment information.
Where is the NCT06487052 trial being conducted?
This trial is being conducted at Saint Petersburg, Russia.
Who is sponsoring the NCT06487052 clinical trial?
NCT06487052 is sponsored by Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health. The trial plans to enroll 100 participants.