Trial · NCT03151993
Single Bolus Recombinant Nonimmunogenic Staphylokinase (Fortelyzin) and Bolus Infusion Alteplase in Patients With AIS
NCT03151993, Phase 3, Completed, Supergene, LLC; results first posted 2025-04-02
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Single Bolus Recombinant Nonimmunogenic Staphylokinase (Fortelyzin) and Bolus Infusion Alteplase in Patients With AIS. Trials, record NCT03151993. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03151993
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Single Bolus Recombinant Nonimmunogenic Staphylokinase (Fortelyzin) and Bolus Infusion Alteplase in Patients With AIS
- NCT number
- NCT03151993
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 336 participants, actual
- Lead sponsor
- Supergene, LLC
- Conditions
- Ischemic Stroke
- Interventions
- Recombinant staphylokinase, Alteplase
- First posted
- 2017-05-12
- Last updated
- 2025-04-02
- Results first posted
- 2025-04-02
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Good Functional Recovery | within 90 days after fibrinolysis | The number of patients with Modified Rankin Scale (mRS) scores 0-1 on day 90 after drug administration, where 0 - No symptoms, 1 - No significant disability. All scale is 0 - No symptoms, 1 - No significant disability, 2 - Slight disability, 3 - Moderate disability, 4 - Moderately severe disability, 5 - Severe disability, 6 - Dead. |
| Secondary | The Number of Patients With Modified Rankin Scale (0-1) + NIHSS (0-1) + Barthel (95-100) | within 90 days after fibrinolysis | Composite endpoint, included the number of patients reached Modified Rankin scale 0-1 score, NIHSS 0-1 score and Barthel index 95-100. Modified Rankin scale: 0 - No symptoms, 1 - No significant disability, 2 - Slight disability, 3 - Moderate disability, 4 - Moderately severe disability, 5 - Severe disability, 6 - Dead. The National Institutes of Health Stroke Scale (NIHSS): 0 - No stroke symptoms, 1-4 - Minor stroke, 5-15 - Moderate stroke, 16-20 - Moderate to severe stroke, 21-42 - Severe stroke. Barthel index: 80-100 - Independent, 60-79 - Minimally dependent, 40-59 - Partially dependent, 20-39 - Very dependent, \<20 - Totally dependent. |
| Secondary | The Median of NIHSS After 24 Hours | after 24 hours | The median of The National Institutes of Health Stroke Scale (NIHSS) at 24 h after drug administration, where: 0 - No stroke symptoms, 1-4 - Minor stroke, 5-15 - Moderate stroke, 16-20 - Moderate to severe stroke, 21-42 - Severe stroke. |
| Secondary | The Median of NIHSS After 90 Days | within 90 days after fibrinolysis | The median of The National Institutes of Health Stroke Scale (NIHSS) after 90 days of drug administration, where: 0 - No stroke symptoms, 1-4 - Minor stroke, 5-15 - Moderate stroke, 16-20 - Moderate to severe stroke, 21-42 - Severe stroke. |
| Secondary | All Cause Death | within 90 days after fibrinolysis | Death caused by any event |
| Secondary | Intracranial Haemorrhage | within 90 days after fibrinolysis | The number of intracranial hemorrhage (events) |
| Secondary | Symptomatic Intracranial Haemorrhage | within 90 days after fibrinolysis | The number of symptomatic intracranial haemorrhage according to ECASS III definition (events). The ECASS III definition of symptomatic intracranial haemorrhage was any haemorrhage with neurologic deterioration, as indicated by an NIHSS score that was higher by 4 points or more than the value at baseline or the lowest value in the first 7 days, or any haemorrhage leading to death. In addition, the haemorrhage must have been identified as the predominant cause of the neurologic deterioration. |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Good Functional Recovery | within 90 days after fibrinolysis | patients | NUMBER | |
| SECONDARY | The Number of Patients With Modified Rankin Scale (0-1) + NIHSS (0-1) + Barthel (95-100) | within 90 days after fibrinolysis | patients | NUMBER | |
| SECONDARY | The Median of NIHSS After 24 Hours | after 24 hours | score | MEDIAN | |
| SECONDARY | The Median of NIHSS After 90 Days | within 90 days after fibrinolysis | score | MEDIAN | |
| SECONDARY | All Cause Death | within 90 days after fibrinolysis | patients | NUMBER | |
| SECONDARY | Intracranial Haemorrhage | within 90 days after fibrinolysis | events | NUMBER | |
| SECONDARY | Symptomatic Intracranial Haemorrhage | within 90 days after fibrinolysis | events | NUMBER |
Source ClinicalTrials.gov
Results by group14
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Good Functional Recovery | Recombinant Staphylokinase | 84 | patients | ||
| Good Functional Recovery | Actilyse | 68 | patients | ||
| The Number of Patients With Modified Rankin Scale (0-1) + NIHSS (0-1) + Barthel (95-100) | Recombinant Staphylokinase | 59 | patients | ||
| The Number of Patients With Modified Rankin Scale (0-1) + NIHSS (0-1) + Barthel (95-100) | Actilyse | 52 | patients | ||
| The Median of NIHSS After 24 Hours | Recombinant Staphylokinase | 6 | Inter-Quartile Range 3 to 11 | score | |
| The Median of NIHSS After 24 Hours | Actilyse | 6 | Inter-Quartile Range 3 to 12 | score | |
| The Median of NIHSS After 90 Days | Recombinant Staphylokinase | 2 | Inter-Quartile Range 1 to 5 | score | |
| The Median of NIHSS After 90 Days | Actilyse | 2 | Inter-Quartile Range 1 to 5 | score | |
| All Cause Death | Recombinant Staphylokinase | 17 | patients | ||
| All Cause Death | Actilyse | 24 | patients |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Recombinant Staphylokinase | 168 | |
| Overall Study | STARTED | Actilyse | 168 | |
| Overall Study | COMPLETED | Recombinant Staphylokinase | 168 | |
| Overall Study | COMPLETED | Actilyse | 168 | |
| Overall Study | NOT COMPLETED | Recombinant Staphylokinase | 0 | |
| Overall Study | NOT COMPLETED | Actilyse | 0 |
Source ClinicalTrials.gov
Adverse events20
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Haematuria | Renal and urinary disorders | Recombinant Staphylokinase | 7 | 168 | 7 |
| other | Haematuria | Renal and urinary disorders | Actilyse | 8 | 168 | 8 |
| serious | Cerebral oedema | Nervous system disorders | Recombinant Staphylokinase | 7 | 168 | 7 |
| serious | Cerebral oedema | Nervous system disorders | Actilyse | 14 | 168 | 14 |
| serious | Symptomatic intracranial haemorrhage | Nervous system disorders | Recombinant Staphylokinase | 5 | 168 | 5 |
| serious | Symptomatic intracranial haemorrhage | Nervous system disorders | Actilyse | 13 | 168 | 13 |
| serious | Surgery | Nervous system disorders | Recombinant Staphylokinase | 5 | 168 | 5 |
| serious | Surgery | Nervous system disorders | Actilyse | 3 | 168 | 3 |
| serious | Neurosurgery | Nervous system disorders | Recombinant Staphylokinase | 2 | 168 | 2 |
| serious | Neurosurgery | Nervous system disorders | Actilyse | 1 | 168 | 1 |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Recombinant Staphylokinase | 17 | 168 |
| Total, all-cause mortality | Actilyse | 24 | 168 |
| Total, other adverse events | Recombinant Staphylokinase | 7 | 168 |
| Total, other adverse events | Actilyse | 8 | 168 |
| Total, serious adverse events | Recombinant Staphylokinase | 22 | 168 |
| Total, serious adverse events | Actilyse | 38 | 168 |
Source ClinicalTrials.gov
Papers13
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Recombinant Staphylokinase vs Actilyse: deaths from any cause | Trial comparisons |
| Recombinant Staphylokinase vs Actilyse: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03151993
GET https://conductscience.org/api/trials/v1/NCT03151993/registered