Trial Outcomes & Findings for Single Bolus Recombinant Nonimmunogenic Staphylokinase Versus Single Bolus Tenecteplase (Metalyse) in STEMI (NCT NCT02301910)

NCT ID: NCT02301910

Last Updated: 2025-03-20

Results Overview

The number of participants with reperfusion by TIMI (Thrombolysis in Myocardial Infarction) 2-3 assessed by coronary arteriography, where grade 0 - no perfusion, grade 1 - penetration without perfusion, grade 2 - partial perfusion, grade 3 - complete perfusion.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 382 participants
• Primary outcome timeframe: 90 min after fibrinolysis
• Results posted on: 2025-03-20

Participant Flow

Participant milestones

Measure	Recombinant Staphylokinase Lyophilizate for solution making for intravenous injection, 5 mg (745000 ME). 15 mg of drug reconstituted in 15 ml of 0.9% solution of NaCl given as single i.v. bolus over 5 - 10 seconds Recombinant staphylokinase: 15 mg of drug reconstituted in 15 ml of 0.9% solution of NaCl given as single i.v. bolus over 5 - 10 seconds	Tenecteplase 50 mg of drug reconstituted in 10 ml sterile water for injection given as single weight-adjusted i.v. bolus over 5 - 10 seconds Weight (kg) Dose (mg) Dose (ml) * 55 to \<60 30 mg 6 ml * 60 to \<70 35 mg 7 ml * 70 to \<80 40 mg 8 ml * 80 to \<90 45 mg 9 ml * 90 50 mg 10 ml Tenecteplase: 50 mg of drug reconstituted in 10 ml sterile water for injection given as single weight-adjusted i.v. bolus over 5 - 10 seconds Weight (kg) Dose (mg) Dose (ml) * 55 to \<60 30 mg 6 ml * 60 to \<70 35 mg 7 ml * 70 to \<80 40 mg 8 ml
Overall Study STARTED	191	191
Overall Study COMPLETED	191	191
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Recombinant Staphylokinase n=191 Participants Lyophilizate for solution making for intravenous injection, 5 mg (745000 ME). 15 mg of drug reconstituted in 15 ml of 0.9% solution of NaCl given as single i.v. bolus over 5 - 10 seconds Recombinant staphylokinase: 15 mg of drug reconstituted in 15 ml of 0.9% solution of NaCl given as single i.v. bolus over 5 - 10 seconds	Tenecteplase n=191 Participants 50 mg of drug reconstituted in 10 ml sterile water for injection given as single weight-adjusted i.v. bolus over 5 - 10 seconds Weight (kg) Dose (mg) Dose (ml) * 55 to \<60 30 mg 6 ml * 60 to \<70 35 mg 7 ml * 70 to \<80 40 mg 8 ml * 80 to \<90 45 mg 9 ml * 90 50 mg 10 ml Tenecteplase: 50 mg of drug reconstituted in 10 ml sterile water for injection given as single weight-adjusted i.v. bolus over 5 - 10 seconds Weight (kg) Dose (mg) Dose (ml) * 55 to \<60 30 mg 6 ml * 60 to \<70 35 mg 7 ml * 70 to \<80 40 mg 8 ml	Total n=382 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=191 Participants	0 Participants n=191 Participants	0 Participants n=382 Participants
Age, Categorical Between 18 and 65 years	141 Participants n=191 Participants	125 Participants n=191 Participants	266 Participants n=382 Participants
Age, Categorical >=65 years	50 Participants n=191 Participants	66 Participants n=191 Participants	116 Participants n=382 Participants
Age, Continuous	58.9 years STANDARD_DEVIATION 9.9 • n=191 Participants	60.01 years STANDARD_DEVIATION 11.25 • n=191 Participants	59.4 years STANDARD_DEVIATION 10.5 • n=382 Participants
Sex: Female, Male Female	146 Participants n=191 Participants	158 Participants n=191 Participants	304 Participants n=382 Participants
Sex: Female, Male Male	45 Participants n=191 Participants	33 Participants n=191 Participants	78 Participants n=382 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment Russia	191 Participants n=191 Participants	191 Participants n=191 Participants	382 Participants n=382 Participants

PRIMARY outcome

Timeframe: 90 min after fibrinolysis

The number of participants with reperfusion by TIMI (Thrombolysis in Myocardial Infarction) 2-3 assessed by coronary arteriography, where grade 0 - no perfusion, grade 1 - penetration without perfusion, grade 2 - partial perfusion, grade 3 - complete perfusion.

Outcome measures

Measure	Recombinant Staphylokinase n=191 Participants Lyophilizate for solution making for intravenous injection, 5 mg (745000 ME). 15 mg of drug reconstituted in 15 ml of 0.9% solution of NaCl given as single i.v. bolus over 5 - 10 seconds Recombinant staphylokinase: 15 mg of drug reconstituted in 15 ml of 0.9% solution of NaCl given as single i.v. bolus over 5 - 10 seconds	Tenecteplase n=191 Participants 50 mg of drug reconstituted in 10 ml sterile water for injection given as single weight-adjusted i.v. bolus over 5 - 10 seconds Weight (kg) Dose (mg) Dose (ml) * 55 to \<60 30 mg 6 ml * 60 to \<70 35 mg 7 ml * 70 to \<80 40 mg 8 ml * 80 to \<90 45 mg 9 ml * 90 50 mg 10 ml Tenecteplase: 50 mg of drug reconstituted in 10 ml sterile water for injection given as single weight-adjusted i.v. bolus over 5 - 10 seconds Weight (kg) Dose (mg) Dose (ml) * 55 to \<60 30 mg 6 ml * 60 to \<70 35 mg 7 ml * 70 to \<80 40 mg 8 ml
The Number of Participants With Reperfusion	133 Participants	131 Participants

SECONDARY outcome

Timeframe: within 30 days after fibrinolysis

All cause death+Reccurent MI+Stroke+Heart failure

Outcome measures

Measure	Recombinant Staphylokinase n=190 Participants Lyophilizate for solution making for intravenous injection, 5 mg (745000 ME). 15 mg of drug reconstituted in 15 ml of 0.9% solution of NaCl given as single i.v. bolus over 5 - 10 seconds Recombinant staphylokinase: 15 mg of drug reconstituted in 15 ml of 0.9% solution of NaCl given as single i.v. bolus over 5 - 10 seconds	Tenecteplase n=191 Participants 50 mg of drug reconstituted in 10 ml sterile water for injection given as single weight-adjusted i.v. bolus over 5 - 10 seconds Weight (kg) Dose (mg) Dose (ml) * 55 to \<60 30 mg 6 ml * 60 to \<70 35 mg 7 ml * 70 to \<80 40 mg 8 ml * 80 to \<90 45 mg 9 ml * 90 50 mg 10 ml Tenecteplase: 50 mg of drug reconstituted in 10 ml sterile water for injection given as single weight-adjusted i.v. bolus over 5 - 10 seconds Weight (kg) Dose (mg) Dose (ml) * 55 to \<60 30 mg 6 ml * 60 to \<70 35 mg 7 ml * 70 to \<80 40 mg 8 ml
Composite Endpoint	24 events	24 events

SECONDARY outcome

Timeframe: within 30 days after fibrinolysis

Death caused by any cardiovascular reason/event

Outcome measures

Measure	Recombinant Staphylokinase n=190 Participants Lyophilizate for solution making for intravenous injection, 5 mg (745000 ME). 15 mg of drug reconstituted in 15 ml of 0.9% solution of NaCl given as single i.v. bolus over 5 - 10 seconds Recombinant staphylokinase: 15 mg of drug reconstituted in 15 ml of 0.9% solution of NaCl given as single i.v. bolus over 5 - 10 seconds	Tenecteplase n=191 Participants 50 mg of drug reconstituted in 10 ml sterile water for injection given as single weight-adjusted i.v. bolus over 5 - 10 seconds Weight (kg) Dose (mg) Dose (ml) * 55 to \<60 30 mg 6 ml * 60 to \<70 35 mg 7 ml * 70 to \<80 40 mg 8 ml * 80 to \<90 45 mg 9 ml * 90 50 mg 10 ml Tenecteplase: 50 mg of drug reconstituted in 10 ml sterile water for injection given as single weight-adjusted i.v. bolus over 5 - 10 seconds Weight (kg) Dose (mg) Dose (ml) * 55 to \<60 30 mg 6 ml * 60 to \<70 35 mg 7 ml * 70 to \<80 40 mg 8 ml
Cardiovascular Death	7 Participants	7 Participants

SECONDARY outcome

Timeframe: within 30 days after fibrinolysis

The need for re-intervention on infarct-related artery within 30 days after fibrinolysis

Outcome measures

Measure	Recombinant Staphylokinase n=190 Participants Lyophilizate for solution making for intravenous injection, 5 mg (745000 ME). 15 mg of drug reconstituted in 15 ml of 0.9% solution of NaCl given as single i.v. bolus over 5 - 10 seconds Recombinant staphylokinase: 15 mg of drug reconstituted in 15 ml of 0.9% solution of NaCl given as single i.v. bolus over 5 - 10 seconds	Tenecteplase n=191 Participants 50 mg of drug reconstituted in 10 ml sterile water for injection given as single weight-adjusted i.v. bolus over 5 - 10 seconds Weight (kg) Dose (mg) Dose (ml) * 55 to \<60 30 mg 6 ml * 60 to \<70 35 mg 7 ml * 70 to \<80 40 mg 8 ml * 80 to \<90 45 mg 9 ml * 90 50 mg 10 ml Tenecteplase: 50 mg of drug reconstituted in 10 ml sterile water for injection given as single weight-adjusted i.v. bolus over 5 - 10 seconds Weight (kg) Dose (mg) Dose (ml) * 55 to \<60 30 mg 6 ml * 60 to \<70 35 mg 7 ml * 70 to \<80 40 mg 8 ml
Repeated Target Vessel Revascularization	2 Participants	2 Participants

SECONDARY outcome

Timeframe: within 30 days after fibrinolysis

In case of at least of the one of the following conditions:

1. Pulmonary oedema/congestion on chest X-ray without suspicion of a non-cardiac cause

2. Rales > 1/3 up from the lung base (Killip class 2 or higher)

3. Pulmonary capillary wedge pressure (PCWP) >25 mmHg

4. Dyspnoea with pO2 < 80 mmHg or O2 sat < 90 % (no supplemental O2) in the absence of known lung disease;

Outcome measures

Measure	Recombinant Staphylokinase n=190 Participants Lyophilizate for solution making for intravenous injection, 5 mg (745000 ME). 15 mg of drug reconstituted in 15 ml of 0.9% solution of NaCl given as single i.v. bolus over 5 - 10 seconds Recombinant staphylokinase: 15 mg of drug reconstituted in 15 ml of 0.9% solution of NaCl given as single i.v. bolus over 5 - 10 seconds	Tenecteplase n=191 Participants 50 mg of drug reconstituted in 10 ml sterile water for injection given as single weight-adjusted i.v. bolus over 5 - 10 seconds Weight (kg) Dose (mg) Dose (ml) * 55 to \<60 30 mg 6 ml * 60 to \<70 35 mg 7 ml * 70 to \<80 40 mg 8 ml * 80 to \<90 45 mg 9 ml * 90 50 mg 10 ml Tenecteplase: 50 mg of drug reconstituted in 10 ml sterile water for injection given as single weight-adjusted i.v. bolus over 5 - 10 seconds Weight (kg) Dose (mg) Dose (ml) * 55 to \<60 30 mg 6 ml * 60 to \<70 35 mg 7 ml * 70 to \<80 40 mg 8 ml
Development of Heart Failure	15 Participants	18 Participants

SECONDARY outcome

Timeframe: within 30 days after fibrinolysis

Outcome measures

Measure	Recombinant Staphylokinase n=190 Participants Lyophilizate for solution making for intravenous injection, 5 mg (745000 ME). 15 mg of drug reconstituted in 15 ml of 0.9% solution of NaCl given as single i.v. bolus over 5 - 10 seconds Recombinant staphylokinase: 15 mg of drug reconstituted in 15 ml of 0.9% solution of NaCl given as single i.v. bolus over 5 - 10 seconds	Tenecteplase n=191 Participants 50 mg of drug reconstituted in 10 ml sterile water for injection given as single weight-adjusted i.v. bolus over 5 - 10 seconds Weight (kg) Dose (mg) Dose (ml) * 55 to \<60 30 mg 6 ml * 60 to \<70 35 mg 7 ml * 70 to \<80 40 mg 8 ml * 80 to \<90 45 mg 9 ml * 90 50 mg 10 ml Tenecteplase: 50 mg of drug reconstituted in 10 ml sterile water for injection given as single weight-adjusted i.v. bolus over 5 - 10 seconds Weight (kg) Dose (mg) Dose (ml) * 55 to \<60 30 mg 6 ml * 60 to \<70 35 mg 7 ml * 70 to \<80 40 mg 8 ml
Rehospitalization Due to Cardiovascular Reasons	0 Participants	1 Participants

SECONDARY outcome

Timeframe: within 30 gays after fibrinolysis

GUSTO classification

Outcome measures

Measure	Recombinant Staphylokinase n=190 Participants Lyophilizate for solution making for intravenous injection, 5 mg (745000 ME). 15 mg of drug reconstituted in 15 ml of 0.9% solution of NaCl given as single i.v. bolus over 5 - 10 seconds Recombinant staphylokinase: 15 mg of drug reconstituted in 15 ml of 0.9% solution of NaCl given as single i.v. bolus over 5 - 10 seconds	Tenecteplase n=191 Participants 50 mg of drug reconstituted in 10 ml sterile water for injection given as single weight-adjusted i.v. bolus over 5 - 10 seconds Weight (kg) Dose (mg) Dose (ml) * 55 to \<60 30 mg 6 ml * 60 to \<70 35 mg 7 ml * 70 to \<80 40 mg 8 ml * 80 to \<90 45 mg 9 ml * 90 50 mg 10 ml Tenecteplase: 50 mg of drug reconstituted in 10 ml sterile water for injection given as single weight-adjusted i.v. bolus over 5 - 10 seconds Weight (kg) Dose (mg) Dose (ml) * 55 to \<60 30 mg 6 ml * 60 to \<70 35 mg 7 ml * 70 to \<80 40 mg 8 ml
Overall Bleeding	1 Participants	1 Participants

SECONDARY outcome

Timeframe: within 30 days after fibrinolysis

Outcome measures

Measure	Recombinant Staphylokinase n=190 Participants Lyophilizate for solution making for intravenous injection, 5 mg (745000 ME). 15 mg of drug reconstituted in 15 ml of 0.9% solution of NaCl given as single i.v. bolus over 5 - 10 seconds Recombinant staphylokinase: 15 mg of drug reconstituted in 15 ml of 0.9% solution of NaCl given as single i.v. bolus over 5 - 10 seconds	Tenecteplase n=191 Participants 50 mg of drug reconstituted in 10 ml sterile water for injection given as single weight-adjusted i.v. bolus over 5 - 10 seconds Weight (kg) Dose (mg) Dose (ml) * 55 to \<60 30 mg 6 ml * 60 to \<70 35 mg 7 ml * 70 to \<80 40 mg 8 ml * 80 to \<90 45 mg 9 ml * 90 50 mg 10 ml Tenecteplase: 50 mg of drug reconstituted in 10 ml sterile water for injection given as single weight-adjusted i.v. bolus over 5 - 10 seconds Weight (kg) Dose (mg) Dose (ml) * 55 to \<60 30 mg 6 ml * 60 to \<70 35 mg 7 ml * 70 to \<80 40 mg 8 ml
Intracranial Haemorrhages	0 Participants	0 Participants

Adverse Events

Recombinant Staphylokinase (Fortelyzin)

Serious events: 40 serious events

Other events: 5 other events

Deaths: 7 deaths

Tenecteplase (Metalyse)

Serious events: 43 serious events

Other events: 7 other events

Deaths: 7 deaths

Serious adverse events

Measure	Recombinant Staphylokinase (Fortelyzin) n=191 participants at risk Recombinant Staphylokinase, administrated as a single intravenous bolus in a dose of 15 mg	Tenecteplase (Metalyse) n=191 participants at risk Tenecteplase administrated in depend on body weight
Cardiac disorders death of all causes	3.7% 7/191 • Number of events 7 • 30 days	3.7% 7/191 • Number of events 7 • 30 days
Cardiac disorders Cardiogenic shock	4.7% 9/191 • Number of events 9 • 30 days	5.2% 10/191 • Number of events 10 • 30 days
Cardiac disorders Repeated MI	4.2% 8/191 • Number of events 8 • 30 days	3.7% 7/191 • Number of events 7 • 30 days
Cardiac disorders Development heart failure	7.9% 15/191 • Number of events 15 • 30 days	9.4% 18/191 • Number of events 18 • 30 days
Blood and lymphatic system disorders Major bleeding	0.52% 1/191 • Number of events 1 • 30 days	0.52% 1/191 • Number of events 1 • 30 days

Other adverse events

Measure	Recombinant Staphylokinase (Fortelyzin) n=191 participants at risk Recombinant Staphylokinase, administrated as a single intravenous bolus in a dose of 15 mg	Tenecteplase (Metalyse) n=191 participants at risk Tenecteplase administrated in depend on body weight
Renal and urinary disorders hematuria	2.6% 5/191 • Number of events 5 • 30 days	3.7% 7/191 • Number of events 7 • 30 days

Additional Information

Markin Sergey

SuperGene LLC

Phone: (495) 287-98-07

Email: info@supergene.ru

Results disclosure agreements

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

Restriction type: OTHER