Evaluating catheter-directed thrombolysis for pulmonary embolism patients

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

This study is testing if a special treatment using a catheter and a low dose of medication can work better than regular blood thinners for people with serious blood clots in their lungs.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health (Academic / other)
• Locations: 1 site (Saint Petersburg)
• Trial ID: NCT06487052 on ClinicalTrials.gov

What this trial studies

This study compares the effectiveness of standard anticoagulant therapy to standard catheter-directed thrombolysis using a low dose of alteplase in patients with intermediate-high-risk acute pulmonary embolism. It is a single-center, open-label, randomized trial where participants will be assigned to one of the two treatment strategies in a 1:1 ratio. The study aims to assess both short- and long-term efficacy and safety outcomes for each treatment approach.

Who should consider this trial

Good fit: Ideal candidates are adults over 18 years with intermediate-high-risk pulmonary embolism confirmed by imaging and specific biomarkers.

Not a fit: Patients with high-risk pulmonary embolism or those with contraindications for thrombolytic therapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a more effective treatment option for patients suffering from acute pulmonary embolism.

How similar studies have performed: Previous studies have shown promise in using catheter-directed thrombolysis for pulmonary embolism, indicating potential for success in this approach.

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

Where this trial is running

Saint Petersburg

• Almazov National Medical Research Centre — Saint Petersburg, Russia (Recruiting)

Study contacts

• Study coordinator: Olga Moiseeva

Conditions Pulmonary Embolism Acute; acute pulmonary embolism; catheter-directed thrombolysis; anticoagulant therapy