Evaluation of the Standard Catheter-directed Thrombolysis Effectiveness in Intermediate-Hi
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, follow
| Condition(s) | Pulmonary Embolism Acute |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| 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 |
| Who can participate | 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 |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health |
| Locations | Saint Petersburg, Russia |
| Start date | 2024-01-10 |
| NCT ID | NCT06487052 |
| Official listing | https://clinicaltrials.gov/study/NCT06487052 |