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)
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;
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;
Parallel
Non-immunogenic recombinant staphylokinase
Drug15 mg of drug reconstituted in 15 ml of 0.9% solution of NaCl given as single i.v. bolus over 10-15 seconds
Placebo
Drug15 mg of placebo reconstituted in 15 ml of 0.9% solution of NaCl given as single i.v. bolus over 10-15 seconds
Composite of death from any cause or hemodynamic collapse or recurrent PE
The efficacy is evaluated in terms of the number of death from any cause or hemodynamic collapse or recurrent PE
Right/left ventricular (RV/LV) end-diastolic diameter ratio
The efficacy is evaluated in terms of the RV/LV end-diastolic diameter ratio according to echocardiography
RV/LV end-diastolic diameter ratio
The efficacy is evaluated in terms of the RV/LV end-diastolic diameter ratio according to computed tomography pulmonary angiography (CTPA)
RV/LV end-diastolic diameter ratio
The efficacy is evaluated in terms of the RV/LV end-diastolic diameter ratio according to echocardiography
Right ventricular (RV) end-diastolic volume
The efficacy is evaluated in terms of the RV end-diastolic volume according to CTPA
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