Clinical trial NCT06487052: Evaluation of the Standard Catheter-directed Thrombolysis Effectiveness in Intermediate-High-Risk Pulmonary Embolism Patients
Official title: Evaluation of the Standard Catheter-directed Thrombolysis (SCDT) Effectiveness in Intermediate-High-Risk Pulmonary Embolism Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pulmonary Embolism Acute
Keywords: acute pulmonary embolism
catheter-directed thrombolysis
anticoagulant therapy
Lead sponsor: Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health
Sponsor class: OTHER
First posted: 2024-07-05
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: patients will be randomized into 2 parallel groups
Primary purpose: TREATMENT

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

Primary outcomes:
measure: A decrease in the ratio of RV/LV diameters
timeFrame: 48 ± 6 hours
Secondary outcomes:
measure: Mortality
timeFrame: 90 days
measure: Cardiorespiratory decompensation or collapse
timeFrame: 7 days
measure: Major bleeding events
timeFrame: 7 days
measure: PE thrombus load reduction
timeFrame: 48 hours
measure: The degree of residual pulmonary artery thrombosis with perfusion deficiency
timeFrame: 180 days
measure: Post-pulmonary embolism syndrome formation
timeFrame: 180 days
Other outcomes:
Locations:
city: Saint Petersburg
country: Russian Federation
facility: Almazov National Medical Research Centre
Study officials:
References:
citation: Konstantinides SV, Meyer G, Becattini C, Bueno H, Geersing GJ, Harjola VP, Huisman MV, Humbert M, Jennings CS, Jimenez D, Kucher N, Lang IM, Lankeit M, Lorusso R, Mazzolai L, Meneveau N, Ni Ainle F, Prandoni P, Pruszczyk P, Righini M, Torbicki A, Van Belle E, Zamorano JL; ESC Scientific Document Group. 2019 ESC Guidelines for the diagnosis and management of acute pulmonary embolism developed in collaboration with the European Respiratory Society (ERS). Eur Heart J. 2020 Jan 21;41(4):543-603. doi: 10.1093/eurheartj/ehz405. No abstract available.