Trial Outcomes & Findings for Massive Pulmonary Embolism: Trial of Non-immunogenic Recombinant Staphylokinase VS Alteplase FORPE (NCT NCT04688320)

NCT ID: NCT04688320

Last Updated: 2025-04-02

Results Overview

The efficacy is evaluated in terms of the number of deaths from all causes

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 310 participants
• Primary outcome timeframe: within 7 days
• Results posted on: 2025-04-02

Participant Flow

Participant milestones

Measure	Recombinant Nonimmunogenic Staphylokinase lyophilisate for preparation of a solution for intravenous administration, 5 mg (745,000 IU) complete with a solvent. 15 mg (2,235,000 IU) - 3 vials, intravenously as a quick single bolus injection for 10-15 seconds, regardless of body weight. Recombinant nonimmunogenic staphylokinase: 15 mg of drug reconstituted in 10 ml of 0.9% solution of NaCl given as single i.v. bolus over 10-15 seconds	Alteplase Alteplase® is administered in accordance with the instructions for use for pulmonary embolism( 10 mg bolus and 90 mg as IV infusion over 2 hours, maximum 100 mg). In patients weighing less than 65 kg, the total dose should not exceed 1.5 mg / kg. Alteplase: Alteplase® is administered in accordance with the instructions for use for pulmonary embolism ( 10 mg bolus and 90 mg as IV infusion over 2 hours, maximum 100 mg). In patients weighing less than 65 kg, the total dose should not exceed 1.5 mg / kg.
Overall Study STARTED	155	155
Overall Study COMPLETED	145	146
Overall Study NOT COMPLETED	10	9

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Massive Pulmonary Embolism: Trial of Non-immunogenic Recombinant Staphylokinase VS Alteplase FORPE

Baseline characteristics by cohort

Measure	Recombinant Nonimmunogenic Staphylokinase n=155 Participants lyophilisate for preparation of a solution for intravenous administration, 5 mg (745,000 IU) complete with a solvent. 15 mg (2,235,000 IU) - 3 vials, intravenously as a quick single bolus injection for 10-15 seconds, regardless of body weight. Recombinant nonimmunogenic staphylokinase: 15 mg of drug reconstituted in 10 ml of 0.9% solution of NaCl given as single i.v. bolus over 10-15 seconds	Alteplase n=155 Participants Alteplase® is administered in accordance with the instructions for use for pulmonary embolism( 10 mg bolus and 90 mg as IV infusion over 2 hours, maximum 100 mg). In patients weighing less than 65 kg, the total dose should not exceed 1.5 mg / kg. Alteplase: Alteplase® is administered in accordance with the instructions for use for pulmonary embolism ( 10 mg bolus and 90 mg as IV infusion over 2 hours, maximum 100 mg). In patients weighing less than 65 kg, the total dose should not exceed 1.5 mg / kg.	Total n=310 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	75 Participants n=5 Participants	94 Participants n=7 Participants	169 Participants n=5 Participants
Age, Categorical >=65 years	80 Participants n=5 Participants	61 Participants n=7 Participants	141 Participants n=5 Participants
Age, Continuous	64 years STANDARD_DEVIATION 13 • n=5 Participants	62 years STANDARD_DEVIATION 13 • n=7 Participants	63 years STANDARD_DEVIATION 13 • n=5 Participants
Sex: Female, Male Female	84 Participants n=5 Participants	74 Participants n=7 Participants	158 Participants n=5 Participants
Sex: Female, Male Male	71 Participants n=5 Participants	81 Participants n=7 Participants	152 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	155 Participants n=5 Participants	155 Participants n=7 Participants	310 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment Russia	155 participants n=5 Participants	155 participants n=7 Participants	310 participants n=5 Participants
Body mass index, kg/m^2	32 kg/m^2 STANDARD_DEVIATION 6 • n=5 Participants	31 kg/m^2 STANDARD_DEVIATION 6 • n=7 Participants	32 kg/m^2 STANDARD_DEVIATION 6 • n=5 Participants
Pulmonary Embolism Severity Index (PESI) score	135 score n=5 Participants	128 score n=7 Participants	132 score n=5 Participants
PESI class V patients	103 Participants n=5 Participants	82 Participants n=7 Participants	185 Participants n=5 Participants
Onset to treatment time	27 h n=5 Participants	17.1 h n=7 Participants	22 h n=5 Participants
Qanadli index	65.8 % of pulmonary artery obstruction STANDARD_DEVIATION 19.8 • n=5 Participants	67.8 % of pulmonary artery obstruction STANDARD_DEVIATION 19.7 • n=7 Participants	66.2 % of pulmonary artery obstruction STANDARD_DEVIATION 19.8 • n=5 Participants
Right ventricle end-diastolic diameter	50 mm n=5 Participants	50 mm n=7 Participants	50 mm n=5 Participants
Right ventricular/lLeft ventricular end-diastolic diameter	1.39 ratio n=5 Participants	1.40 ratio n=7 Participants	1.40 ratio n=5 Participants
Baseline systolic blood pressure	90 mm Hg n=5 Participants	90 mm Hg n=7 Participants	90 mm Hg n=5 Participants
Baseline diastolic blood pressure	60 mm Hg n=5 Participants	60 mm Hg n=7 Participants	60 mm Hg n=5 Participants
Baseline heart rate	110 beats per min n=5 Participants	110 beats per min n=7 Participants	110 beats per min n=5 Participants
Baseline respiratory rate	24 breaths per min n=5 Participants	24 breaths per min n=7 Participants	24 breaths per min n=5 Participants
Baseline SpO2	89 % n=5 Participants	89 % n=7 Participants	89 % n=5 Participants

PRIMARY outcome

Timeframe: within 7 days

Population: in the per-protocol population

The efficacy is evaluated in terms of the number of deaths from all causes

Outcome measures

Measure	Recombinant Nonimmunogenic Staphylokinase n=145 Participants lyophilisate for preparation of a solution for intravenous administration, 5 mg (745,000 IU) complete with a solvent. 15 mg (2,235,000 IU) - 3 vials, intravenously as a quick single bolus injection for 10-15 seconds, regardless of body weight. Recombinant nonimmunogenic staphylokinase: 15 mg of drug reconstituted in 10 ml of 0.9% solution of NaCl given as single i.v. bolus over 10-15 seconds	Alteplase n=146 Participants Alteplase® is administered in accordance with the instructions for use for pulmonary embolism( 10 mg bolus and 90 mg as IV infusion over 2 hours, maximum 100 mg). In patients weighing less than 65 kg, the total dose should not exceed 1.5 mg / kg. Alteplase: Alteplase® is administered in accordance with the instructions for use for pulmonary embolism ( 10 mg bolus and 90 mg as IV infusion over 2 hours, maximum 100 mg). In patients weighing less than 65 kg, the total dose should not exceed 1.5 mg / kg.
Death From All Causes	3 Participants	4 Participants

SECONDARY outcome

Timeframe: baseline and day 1, 7, 14 after randomisation

Population: The efficacy is evaluated in terms of decreasing of pulmonary artery systolic pressure (PASP) values on baseline and day 1, 7, 14 after randomisation in the per-protocol population

The efficacy is evaluated in terms of systolic pulmonary artery pressure values

Outcome measures

Measure	Recombinant Nonimmunogenic Staphylokinase n=145 Participants lyophilisate for preparation of a solution for intravenous administration, 5 mg (745,000 IU) complete with a solvent. 15 mg (2,235,000 IU) - 3 vials, intravenously as a quick single bolus injection for 10-15 seconds, regardless of body weight. Recombinant nonimmunogenic staphylokinase: 15 mg of drug reconstituted in 10 ml of 0.9% solution of NaCl given as single i.v. bolus over 10-15 seconds	Alteplase n=145 Participants Alteplase® is administered in accordance with the instructions for use for pulmonary embolism( 10 mg bolus and 90 mg as IV infusion over 2 hours, maximum 100 mg). In patients weighing less than 65 kg, the total dose should not exceed 1.5 mg / kg. Alteplase: Alteplase® is administered in accordance with the instructions for use for pulmonary embolism ( 10 mg bolus and 90 mg as IV infusion over 2 hours, maximum 100 mg). In patients weighing less than 65 kg, the total dose should not exceed 1.5 mg / kg.
Systolic Pulmonary Artery Pressure Measures (V1, V2, V4, V5) PASP on baseline	59 mm Hg Interval 50.0 to 69.0	58 mm Hg Interval 51.0 to 69.0
Systolic Pulmonary Artery Pressure Measures (V1, V2, V4, V5) PASP on day 1	44 mm Hg Interval 36.0 to 52.0	42 mm Hg Interval 36.0 to 50.0
Systolic Pulmonary Artery Pressure Measures (V1, V2, V4, V5) PASP on day 7	36 mm Hg Interval 31.0 to 44.0	35 mm Hg Interval 29.0 to 41.0
Systolic Pulmonary Artery Pressure Measures (V1, V2, V4, V5) PASP on day 14	35 mm Hg Interval 30.0 to 41.0	35 mm Hg Interval 28.0 to 41.0

SECONDARY outcome

Timeframe: within 7 days

Population: The efficacy is evaluated in terms of the number of haemodynamic collapse in the per-protocol population

The efficacy is evaluated in terms of the number of haemodynamic collapse

Outcome measures

Measure	Recombinant Nonimmunogenic Staphylokinase n=145 Participants lyophilisate for preparation of a solution for intravenous administration, 5 mg (745,000 IU) complete with a solvent. 15 mg (2,235,000 IU) - 3 vials, intravenously as a quick single bolus injection for 10-15 seconds, regardless of body weight. Recombinant nonimmunogenic staphylokinase: 15 mg of drug reconstituted in 10 ml of 0.9% solution of NaCl given as single i.v. bolus over 10-15 seconds	Alteplase n=146 Participants Alteplase® is administered in accordance with the instructions for use for pulmonary embolism( 10 mg bolus and 90 mg as IV infusion over 2 hours, maximum 100 mg). In patients weighing less than 65 kg, the total dose should not exceed 1.5 mg / kg. Alteplase: Alteplase® is administered in accordance with the instructions for use for pulmonary embolism ( 10 mg bolus and 90 mg as IV infusion over 2 hours, maximum 100 mg). In patients weighing less than 65 kg, the total dose should not exceed 1.5 mg / kg.
Haemodynamic Collapse	1 events	3 events

SECONDARY outcome

Timeframe: within 7 days

Population: The efficacy is evaluated in terms of the number of recurrent PE in the per-protocol population

The efficacy is evaluated in terms of the number of recurrent PE

Outcome measures

Measure	Recombinant Nonimmunogenic Staphylokinase n=145 Participants lyophilisate for preparation of a solution for intravenous administration, 5 mg (745,000 IU) complete with a solvent. 15 mg (2,235,000 IU) - 3 vials, intravenously as a quick single bolus injection for 10-15 seconds, regardless of body weight. Recombinant nonimmunogenic staphylokinase: 15 mg of drug reconstituted in 10 ml of 0.9% solution of NaCl given as single i.v. bolus over 10-15 seconds	Alteplase n=146 Participants Alteplase® is administered in accordance with the instructions for use for pulmonary embolism( 10 mg bolus and 90 mg as IV infusion over 2 hours, maximum 100 mg). In patients weighing less than 65 kg, the total dose should not exceed 1.5 mg / kg. Alteplase: Alteplase® is administered in accordance with the instructions for use for pulmonary embolism ( 10 mg bolus and 90 mg as IV infusion over 2 hours, maximum 100 mg). In patients weighing less than 65 kg, the total dose should not exceed 1.5 mg / kg.
Recurrent Pulmonary Embolism (PE)	1 events	2 events

SECONDARY outcome

Timeframe: within 30 days

Population: The efficacy is evaluated in terms of the number of deaths from PE in the per-protocol population

The efficacy is evaluated in terms of the number of deaths from PE

Outcome measures

Measure	Recombinant Nonimmunogenic Staphylokinase n=145 Participants lyophilisate for preparation of a solution for intravenous administration, 5 mg (745,000 IU) complete with a solvent. 15 mg (2,235,000 IU) - 3 vials, intravenously as a quick single bolus injection for 10-15 seconds, regardless of body weight. Recombinant nonimmunogenic staphylokinase: 15 mg of drug reconstituted in 10 ml of 0.9% solution of NaCl given as single i.v. bolus over 10-15 seconds	Alteplase n=146 Participants Alteplase® is administered in accordance with the instructions for use for pulmonary embolism( 10 mg bolus and 90 mg as IV infusion over 2 hours, maximum 100 mg). In patients weighing less than 65 kg, the total dose should not exceed 1.5 mg / kg. Alteplase: Alteplase® is administered in accordance with the instructions for use for pulmonary embolism ( 10 mg bolus and 90 mg as IV infusion over 2 hours, maximum 100 mg). In patients weighing less than 65 kg, the total dose should not exceed 1.5 mg / kg.
Death From PE	4 Participants	2 Participants

SECONDARY outcome

Timeframe: within 30 days

Population: The efficacy is evaluated in terms of the number of deaths from all causes in the per-protocol population

The efficacy is evaluated in terms of the number of deaths from all causes

Outcome measures

Measure	Recombinant Nonimmunogenic Staphylokinase n=145 Participants lyophilisate for preparation of a solution for intravenous administration, 5 mg (745,000 IU) complete with a solvent. 15 mg (2,235,000 IU) - 3 vials, intravenously as a quick single bolus injection for 10-15 seconds, regardless of body weight. Recombinant nonimmunogenic staphylokinase: 15 mg of drug reconstituted in 10 ml of 0.9% solution of NaCl given as single i.v. bolus over 10-15 seconds	Alteplase n=146 Participants Alteplase® is administered in accordance with the instructions for use for pulmonary embolism( 10 mg bolus and 90 mg as IV infusion over 2 hours, maximum 100 mg). In patients weighing less than 65 kg, the total dose should not exceed 1.5 mg / kg. Alteplase: Alteplase® is administered in accordance with the instructions for use for pulmonary embolism ( 10 mg bolus and 90 mg as IV infusion over 2 hours, maximum 100 mg). In patients weighing less than 65 kg, the total dose should not exceed 1.5 mg / kg.
Death From All Causes	6 Participants	4 Participants

SECONDARY outcome

Timeframe: within 30 days

Population: The efficacy is evaluated in terms of the number of haemodynamic collapse + recurrent PE + deaths from all causes within 30 days in the per-protocol population

The efficacy is evaluated in terms of the number of haemodynamic collapse + recurrent PE + deaths from all causes

Outcome measures

Measure	Recombinant Nonimmunogenic Staphylokinase n=145 Participants lyophilisate for preparation of a solution for intravenous administration, 5 mg (745,000 IU) complete with a solvent. 15 mg (2,235,000 IU) - 3 vials, intravenously as a quick single bolus injection for 10-15 seconds, regardless of body weight. Recombinant nonimmunogenic staphylokinase: 15 mg of drug reconstituted in 10 ml of 0.9% solution of NaCl given as single i.v. bolus over 10-15 seconds	Alteplase n=146 Participants Alteplase® is administered in accordance with the instructions for use for pulmonary embolism( 10 mg bolus and 90 mg as IV infusion over 2 hours, maximum 100 mg). In patients weighing less than 65 kg, the total dose should not exceed 1.5 mg / kg. Alteplase: Alteplase® is administered in accordance with the instructions for use for pulmonary embolism ( 10 mg bolus and 90 mg as IV infusion over 2 hours, maximum 100 mg). In patients weighing less than 65 kg, the total dose should not exceed 1.5 mg / kg.
Haemodynamic Collapse Within 7 Days + Recurrent PE Within 7 Days + Death From All Causes Within 30 Days	8 events	9 events

SECONDARY outcome

Timeframe: within 7 days

Population: The safety is evaluated in terms of the number of haemorrhagic stroke within 7 days of randomisation in the per-protocol population

The safety is evaluated in terms of the number of haemorrhagic stroke within 7 days of randomisation

Outcome measures

Measure	Recombinant Nonimmunogenic Staphylokinase n=145 Participants lyophilisate for preparation of a solution for intravenous administration, 5 mg (745,000 IU) complete with a solvent. 15 mg (2,235,000 IU) - 3 vials, intravenously as a quick single bolus injection for 10-15 seconds, regardless of body weight. Recombinant nonimmunogenic staphylokinase: 15 mg of drug reconstituted in 10 ml of 0.9% solution of NaCl given as single i.v. bolus over 10-15 seconds	Alteplase n=146 Participants Alteplase® is administered in accordance with the instructions for use for pulmonary embolism( 10 mg bolus and 90 mg as IV infusion over 2 hours, maximum 100 mg). In patients weighing less than 65 kg, the total dose should not exceed 1.5 mg / kg. Alteplase: Alteplase® is administered in accordance with the instructions for use for pulmonary embolism ( 10 mg bolus and 90 mg as IV infusion over 2 hours, maximum 100 mg). In patients weighing less than 65 kg, the total dose should not exceed 1.5 mg / kg.
Safety Endpoint - Haemorrhagic Stroke	0 events	3 events

SECONDARY outcome

Timeframe: within 30 days

Population: The safety is evaluated in terms of the number of BARC type 3+5 bleeding within 30 days in the per-protocol population

The safety is evaluated in terms of the number of BARC type 3+5 bleeding. Type 3a: overt bleeding plus a hemoglobin drop of 3 to 5 g/dL; any transfusion with overt bleeding.

Type 3b: overt bleeding plus a hemoglobin drop of 5 g/dL; cardiac tamponade; bleeding requiring surgical intervention for control; bleeding requiring intravenous vasoactive agents.

Type 3c: intracranial hemorrhage (does not include microbleeds or hemorrhagic transformation, does include intraspinal); subcategories confirmed by autopsy or imaging, or lumbar puncture; intraocular bleed compromising vision.

Type 5a: probable fatal bleeding; no autopsy or imaging confirmation but clinically suspicious.

Type 5b: definite fatal bleeding; overt bleeding or autopsy, or imaging confirmation.

Outcome measures

Measure	Recombinant Nonimmunogenic Staphylokinase n=145 Participants lyophilisate for preparation of a solution for intravenous administration, 5 mg (745,000 IU) complete with a solvent. 15 mg (2,235,000 IU) - 3 vials, intravenously as a quick single bolus injection for 10-15 seconds, regardless of body weight. Recombinant nonimmunogenic staphylokinase: 15 mg of drug reconstituted in 10 ml of 0.9% solution of NaCl given as single i.v. bolus over 10-15 seconds	Alteplase n=146 Participants Alteplase® is administered in accordance with the instructions for use for pulmonary embolism( 10 mg bolus and 90 mg as IV infusion over 2 hours, maximum 100 mg). In patients weighing less than 65 kg, the total dose should not exceed 1.5 mg / kg. Alteplase: Alteplase® is administered in accordance with the instructions for use for pulmonary embolism ( 10 mg bolus and 90 mg as IV infusion over 2 hours, maximum 100 mg). In patients weighing less than 65 kg, the total dose should not exceed 1.5 mg / kg.
Safety Endpoint - BARC Type 3+5 Bleeding	0 events	5 events

SECONDARY outcome

Timeframe: within 30 days

Population: The safety is evaluated in terms of the number and severity of serious adverse events (SAEs) in the per-protocol population

The safety is evaluated in terms of the number and severity of serious adverse events (SAEs)

Outcome measures

Measure	Recombinant Nonimmunogenic Staphylokinase n=145 Participants lyophilisate for preparation of a solution for intravenous administration, 5 mg (745,000 IU) complete with a solvent. 15 mg (2,235,000 IU) - 3 vials, intravenously as a quick single bolus injection for 10-15 seconds, regardless of body weight. Recombinant nonimmunogenic staphylokinase: 15 mg of drug reconstituted in 10 ml of 0.9% solution of NaCl given as single i.v. bolus over 10-15 seconds	Alteplase n=146 Participants Alteplase® is administered in accordance with the instructions for use for pulmonary embolism( 10 mg bolus and 90 mg as IV infusion over 2 hours, maximum 100 mg). In patients weighing less than 65 kg, the total dose should not exceed 1.5 mg / kg. Alteplase: Alteplase® is administered in accordance with the instructions for use for pulmonary embolism ( 10 mg bolus and 90 mg as IV infusion over 2 hours, maximum 100 mg). In patients weighing less than 65 kg, the total dose should not exceed 1.5 mg / kg.
Safety Endpoint - Number and Severity of Serious Adverse Events (SAEs)	9 events	17 events

Adverse Events

Recombinant Nonimmunogenic Staphylokinase

Serious events: 9 serious events

Other events: 72 other events

Deaths: 6 deaths

Alteplase

Serious events: 17 serious events

Other events: 86 other events

Deaths: 4 deaths

Serious adverse events

Measure	Recombinant Nonimmunogenic Staphylokinase n=155 participants at risk；n=145 participants at risk lyophilisate for preparation of a solution for intravenous administration, 5 mg (745,000 IU) complete with a solvent. 15 mg (2,235,000 IU) - 3 vials, intravenously as a quick single bolus injection for 10-15 seconds, regardless of body weight. Recombinant nonimmunogenic staphylokinase: 15 mg of drug reconstituted in 10 ml of 0.9% solution of NaCl given as single i.v. bolus over 10-15 seconds	Alteplase n=155 participants at risk；n=146 participants at risk Alteplase® is administered in accordance with the instructions for use for pulmonary embolism( 10 mg bolus and 90 mg as IV infusion over 2 hours, maximum 100 mg). In patients weighing less than 65 kg, the total dose should not exceed 1.5 mg / kg. Alteplase: Alteplase® is administered in accordance with the instructions for use for pulmonary embolism ( 10 mg bolus and 90 mg as IV infusion over 2 hours, maximum 100 mg). In patients weighing less than 65 kg, the total dose should not exceed 1.5 mg / kg.
Cardiac disorders Recurrent PE	0.69% 1/145 • Number of events 1 • 30 days. Death from all causes; Recurrent PE; Haemodynamic collapse; Ischaemic stroke; Haemorrhagic stroke; Cerebral oedema; Brainstem damage; Haematoma of the thigh; Pulmonary haemorrhage.	1.4% 2/146 • Number of events 2 • 30 days. Death from all causes; Recurrent PE; Haemodynamic collapse; Ischaemic stroke; Haemorrhagic stroke; Cerebral oedema; Brainstem damage; Haematoma of the thigh; Pulmonary haemorrhage.
Cardiac disorders Haemodynamic collapse	0.69% 1/145 • Number of events 1 • 30 days. Death from all causes; Recurrent PE; Haemodynamic collapse; Ischaemic stroke; Haemorrhagic stroke; Cerebral oedema; Brainstem damage; Haematoma of the thigh; Pulmonary haemorrhage.	2.1% 3/146 • Number of events 3 • 30 days. Death from all causes; Recurrent PE; Haemodynamic collapse; Ischaemic stroke; Haemorrhagic stroke; Cerebral oedema; Brainstem damage; Haematoma of the thigh; Pulmonary haemorrhage.
Nervous system disorders Ischaemic stroke	0.69% 1/145 • Number of events 1 • 30 days. Death from all causes; Recurrent PE; Haemodynamic collapse; Ischaemic stroke; Haemorrhagic stroke; Cerebral oedema; Brainstem damage; Haematoma of the thigh; Pulmonary haemorrhage.	0.00% 0/146 • 30 days. Death from all causes; Recurrent PE; Haemodynamic collapse; Ischaemic stroke; Haemorrhagic stroke; Cerebral oedema; Brainstem damage; Haematoma of the thigh; Pulmonary haemorrhage.
Nervous system disorders Haemorrhagic stroke	0.00% 0/145 • 30 days. Death from all causes; Recurrent PE; Haemodynamic collapse; Ischaemic stroke; Haemorrhagic stroke; Cerebral oedema; Brainstem damage; Haematoma of the thigh; Pulmonary haemorrhage.	2.1% 3/146 • Number of events 3 • 30 days. Death from all causes; Recurrent PE; Haemodynamic collapse; Ischaemic stroke; Haemorrhagic stroke; Cerebral oedema; Brainstem damage; Haematoma of the thigh; Pulmonary haemorrhage.
Nervous system disorders Cerebral oedema	0.00% 0/145 • 30 days. Death from all causes; Recurrent PE; Haemodynamic collapse; Ischaemic stroke; Haemorrhagic stroke; Cerebral oedema; Brainstem damage; Haematoma of the thigh; Pulmonary haemorrhage.	1.4% 2/146 • Number of events 2 • 30 days. Death from all causes; Recurrent PE; Haemodynamic collapse; Ischaemic stroke; Haemorrhagic stroke; Cerebral oedema; Brainstem damage; Haematoma of the thigh; Pulmonary haemorrhage.
Nervous system disorders Brainstem damage	0.00% 0/145 • 30 days. Death from all causes; Recurrent PE; Haemodynamic collapse; Ischaemic stroke; Haemorrhagic stroke; Cerebral oedema; Brainstem damage; Haematoma of the thigh; Pulmonary haemorrhage.	0.68% 1/146 • Number of events 1 • 30 days. Death from all causes; Recurrent PE; Haemodynamic collapse; Ischaemic stroke; Haemorrhagic stroke; Cerebral oedema; Brainstem damage; Haematoma of the thigh; Pulmonary haemorrhage.
Cardiac disorders Haematoma of the thigh	0.00% 0/145 • 30 days. Death from all causes; Recurrent PE; Haemodynamic collapse; Ischaemic stroke; Haemorrhagic stroke; Cerebral oedema; Brainstem damage; Haematoma of the thigh; Pulmonary haemorrhage.	0.68% 1/146 • Number of events 1 • 30 days. Death from all causes; Recurrent PE; Haemodynamic collapse; Ischaemic stroke; Haemorrhagic stroke; Cerebral oedema; Brainstem damage; Haematoma of the thigh; Pulmonary haemorrhage.
Respiratory, thoracic and mediastinal disorders Pulmonary haemorrhage	0.00% 0/145 • 30 days. Death from all causes; Recurrent PE; Haemodynamic collapse; Ischaemic stroke; Haemorrhagic stroke; Cerebral oedema; Brainstem damage; Haematoma of the thigh; Pulmonary haemorrhage.	0.68% 1/146 • Number of events 1 • 30 days. Death from all causes; Recurrent PE; Haemodynamic collapse; Ischaemic stroke; Haemorrhagic stroke; Cerebral oedema; Brainstem damage; Haematoma of the thigh; Pulmonary haemorrhage.
Cardiac disorders Death from all causes	4.1% 6/145 • Number of events 6 • 30 days. Death from all causes; Recurrent PE; Haemodynamic collapse; Ischaemic stroke; Haemorrhagic stroke; Cerebral oedema; Brainstem damage; Haematoma of the thigh; Pulmonary haemorrhage.	2.7% 4/146 • Number of events 4 • 30 days. Death from all causes; Recurrent PE; Haemodynamic collapse; Ischaemic stroke; Haemorrhagic stroke; Cerebral oedema; Brainstem damage; Haematoma of the thigh; Pulmonary haemorrhage.

Other adverse events

Measure	Recombinant Nonimmunogenic Staphylokinase n=155 participants at risk；n=145 participants at risk lyophilisate for preparation of a solution for intravenous administration, 5 mg (745,000 IU) complete with a solvent. 15 mg (2,235,000 IU) - 3 vials, intravenously as a quick single bolus injection for 10-15 seconds, regardless of body weight. Recombinant nonimmunogenic staphylokinase: 15 mg of drug reconstituted in 10 ml of 0.9% solution of NaCl given as single i.v. bolus over 10-15 seconds	Alteplase n=155 participants at risk；n=146 participants at risk Alteplase® is administered in accordance with the instructions for use for pulmonary embolism( 10 mg bolus and 90 mg as IV infusion over 2 hours, maximum 100 mg). In patients weighing less than 65 kg, the total dose should not exceed 1.5 mg / kg. Alteplase: Alteplase® is administered in accordance with the instructions for use for pulmonary embolism ( 10 mg bolus and 90 mg as IV infusion over 2 hours, maximum 100 mg). In patients weighing less than 65 kg, the total dose should not exceed 1.5 mg / kg.
Blood and lymphatic system disorders Hematuria	46.5% 72/155 • Number of events 72 • 30 days. Death from all causes; Recurrent PE; Haemodynamic collapse; Ischaemic stroke; Haemorrhagic stroke; Cerebral oedema; Brainstem damage; Haematoma of the thigh; Pulmonary haemorrhage.	55.5% 86/155 • Number of events 86 • 30 days. Death from all causes; Recurrent PE; Haemodynamic collapse; Ischaemic stroke; Haemorrhagic stroke; Cerebral oedema; Brainstem damage; Haematoma of the thigh; Pulmonary haemorrhage.

Additional Information

Dr. Sergey Markin

LLC "SuperGene"

Phone: (495) 287-98-07

Email: info@supergene.ru

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place