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

Status: Recruiting
Location: See location...
Intervention Type: Combination product, Drug
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Russian Federation
Almazov National Medical Research Centre
RECRUITING
Saint Petersburg
Contact Information
Primary
Olga Moiseeva
moiseeva_om@almazovcentre.ru
+79213068249
Backup
Maria Simakova
simakova_ma@almazovcentre.ru
+79215898763
Time Frame
Start Date: 2024-01-10
Estimated Completion Date: 2027-12
Participants
Target number of participants: 100
Treatments
Experimental: Standard Catheter-Directed 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
Active_comparator: 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.
Related Therapeutic Areas
Sponsors
Leads: Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health

This content was sourced from clinicaltrials.gov