Evaluation of the Standard Catheter-directed Thrombolysis Effectiveness in Intermediate-High-Risk Pulmonary Embolism Patients

Not Applicable

Recruiting

• Conditions: Pulmonary Embolism Acute
• Interventions: Drug: Standard Anticoagulation; Combination Product: Standard Catheter-Directed Low Dose Thrombolysis

• Registration Number: NCT06487052
• Lead Sponsor: Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health

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

Detailed Description

Not available

Study Timeline

• Study Start: 2024-01-10
• Status Verified: 2024-06
• Study First Submitted: 2024-06-27
• Study First Submitted QC: 2024-06-27
• Last Update Submitted: 2024-06-27
• Study First Posted: 2024-07-05
• Last Update Posted: 2024-07-05
• Primary Completion: 2027-01
• Study Completion: 2027-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard Anticoagulation	Standard Anticoagulation	Therapy with UFH with targeted аPTT lasts for 24 hours (no more than 48 hours in total). Then the change to oral anticoagulants is performed.
Standard Catheter-Directed Thrombolysis	Standard Catheter-Directed Low Dose Thrombolysis	Local, standard catheter-directed thrombolysis with a total alteplase dose of 10 mg (for unilateral lesion) or 20 mg (for bilateral lesion) administered over 9 hours

Primary Outcome Measures

Name	Time	Method
A decrease in the ratio of RV/LV diameters	48 ± 6 hours	A decrease in the ratio of RV/LV diameters by 20% or more from the initial value 48 ± 6 hours after initiation of therapy

Secondary Outcome Measures

Name	Time	Method
Mortality	90 days	Mortality
PE thrombus load reduction	48 hours	Qanadli score by CT-scan
Post-pulmonary embolism syndrome formation	180 days	The presence of symptomatic pulmonary artery residual thrombosis
The degree of residual pulmonary artery thrombosis with perfusion deficiency	180 days	The degree of residual pulmonary artery thrombosis with perfusion deficiency by CT-scan
Cardiorespiratory decompensation or collapse	7 days	necessity of inotropic and vasopressor support; cardiac arrest or need for CPR; obstructive shock, placement on extracorporeal membrane oxygenation (ECMO), intubation, or initiation of non-invasive mechanical ventilation
Major bleeding events	7 days	International Society on Thrombosis and Hemostasis (ISTH) major bleeding

Trial Locations

Locations (1)

Almazov National Medical Research Centre; 🇷🇺 Saint Petersburg, Russian Federation