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Non-immunogenic Recombinant Staphylokinase vs Placebo in Patients With Intermediate High-risk Pulmonary Embolism

NCT06362746 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 486

Last updated 2025-12-05

No results posted yet for this study

Summary

Objective: to evaluate the efficacy and safety of the non-immunogenic recombinant staphylokinase with its single bolus administration in comparison with placebo in normotensive patients with intermediate high-risk pulmonary embolism (PE)

Conditions

Interventions

DRUG

Non-immunogenic recombinant staphylokinase

15 mg of drug reconstituted in 15 ml of 0.9% solution of NaCl given as single i.v. bolus over 10-15 seconds

DRUG

Placebo

15 mg of placebo reconstituted in 15 ml of 0.9% solution of NaCl given as single i.v. bolus over 10-15 seconds

Sponsors & Collaborators

  • Supergene, LLC

    lead INDUSTRY

Principal Investigators

  • Sergey N. Tereschenko, MD, PhD · National Medical Research Center for Cardiology, Ministry of Health of Russian Federation

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-05-23
Primary Completion
2028-06-01
Completion
2028-12-01

Countries

  • Russia

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06362746 on ClinicalTrials.gov