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

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorSupergene, LLC

About this trial

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)

Eligibility criteria

Qualifiers

Men and women aged 18 and over.

Verified diagnosis of intermediate high-risk PE using CTPA, no more than two weeks from the symptoms onset.

RV dysfunction, defined as a RV/LV ventricular end-diastolic diameter ratio more than 1.0 assessed by CTPA.

systolic blood pressure less than 110 mm Hg, but not less than 90 mm Hg for more than 15 minutes;

Disqualifiers

High-risk PE with hemodynamic instability.

extensive bleeding at present or within the previous 6 months;

intracranial (including subarachnoid) hemorrhage at present or in history;

hemorrhagic stroke within the last 6 months;

Trial design

Treatments tested in this trial

  • Non-immunogenic recombinant staphylokinase
  • Placebo

Treatment groups

486 Participants
are divided into 2 treatment groups

Sponsors and collaborators