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