Actively Recruiting
Evaluation of the Standard Catheter-directed Thrombolysis Effectiveness in Intermediate-High-Risk Pulmonary Embolism Patients
Led by Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health · Updated on 2024-07-05
100
Participants Needed
1
Research Sites
203 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Evaluation of the Standard Catheter-directed Thrombolysis Effectiveness in Intermediate-High-Risk Pulmonary Embolism Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age > 18 years
- Pulmonary embolism confirmed by CT angiography in the proximal pulmonary arteries with symptoms starting less than 14 days ago
- Intermediate-high risk pulmonary embolism with right ventricular dysfunction (RV/LV diameter ratio >1) and elevated biomarkers (hs-troponin or NT-proBNP)
- Signed informed consent
You will not qualify if you...
- High-risk pulmonary embolism
- Presence of thrombus in heart chambers on echocardiography
- Absolute contraindications to thrombolytic therapy including recent stroke, bleeding disorders, central nervous system diseases, severe uncontrolled hypertension, recent major surgery or trauma, recent labor, severe liver disease, active infections like bacterial endocarditis or pericarditis, acute pancreatitis, recent peptic ulcer, arterial aneurysms, or congenital vascular anomalies
- Hemoglobin level below 70 g/L or platelet count ≤ 100 x 10^9
- Allergy to alteplase, unfractionated heparin, or contrast agents
- Pregnancy or breastfeeding
- Clinically significant cancers
AI-Screening
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Trial Site Locations
Total: 1 location
1
Almazov National Medical Research Centre
Saint Petersburg, Russia, 197341
Actively Recruiting
Research Team
O
Olga Moiseeva
CONTACT
M
Maria Simakova
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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