CompletedNCT03151993Updated Apr 2, 2025Results posted

Single Bolus Recombinant Nonimmunogenic Staphylokinase (Fortelyzin) and Bolus Infusion Alteplase in Patients With AIS

A Phase 3 interventional study of Recombinant staphylokinase and Alteplase in Ischemic Stroke, sponsored by Supergene, LLC. Completed at 18 sites in Russian Federation. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-04-02.

Sponsored by Supergene, LLC · Phase 3, Interventional, and Treatment

Phase: Phase 3
Study type: Interventional
Enrollment: 336
Allocation: Randomized
Ages: 18 Years and older
Sex: All

Study summary

The aim of the study is to determine if single-bolus recombinant nonimmunogenic staphylokinase is effective and save thrombolytic agent in patients with ischemic stroke in comparison to alteplase.

Read the detailed description

Experimental Drug Profile. The active substance of Fortelyzin is Forteplase. It's recombinant protein which contains aminoacid sequence of staphylokinase. It is single chain molecula, consists of 138 aminoacids, weight 15.5 kDa. When staphylokinase is added to human plasma containing a fibrin clot, it preferentially reacts with plasmin at the clot surface, forming a plasmin-staphylokinase complex. This complex activates plasminogen trapped in the thrombus. The plasmin-staphylokinase complex and plasmin bound to fibrin are protected from inhibition by alpha2-antiplasmin. Once liberated from the clot (or generated in plasma), however, they are rapidly inhibited by alpha2-antiplasmin. This selectivity of action confines the process of plasminogen activation to the thrombus, preventing excessive plasmin generation, alpha2-antiplasmin depletion, and fibrinogen degradation in plasma. In rabbits anti forteplase antibodies are not produced. It was achieved by replacement of amino acids in immunogenic epitop of molecule staphylokinase. Blood fibrinogen decrease after i.v. injection of Fortelyzin less 10% within first 24 hours. Angiographic data suggests that restoration of coronary blood flow appears in up to 80% of patients with STEMI after i.v. injection of Fortelyzin.

Main goals of the study are to prove an efficacy of the single-bolus intravenous injection of recombinant nonimmunogenic staphylokinase (Fortelyzin) in comparison with bolus infusion alteplase(Actilyse) in patients with ischemic stroke.

To prove a safety and to assess possible adverse events in the single-bolus intravenous injection of recombinant nonimmunogenic staphylokinase (Fortelyzin) in comparison with bolus infusion alteplase (Actilyse) in patients with ischemic stroke.

Study Design. All eligible patients will be randomized in two equal groups for administration recombinant nonimmunogenic staphylokinase (Fortelyzin) or alteplase (Actilyse) by using "envelope method" of randomization. It is an open-lable study. Each of agents will be administered no longer then 4,5 hours from symptoms onset. Comparative agent will be administered as prescribed in its instructions. All patients will be examination for 90 days

Conditions studied

Ischemic Stroke

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Keywords

Acute Ischemic Stroke
Fibrinolysis
Fortelyzin

In context

Stroke

7,286 studies on the registry are indexed under Stroke; 2,013 are open to participants now.

This study's enrollment of 336 is above the median of 50 across 5,366 interventional studies indexed under Stroke.

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Lead sponsor

Supergene, LLC is the lead sponsor of 9 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

Men and women between the ages of 18 and 80 (Version 1.0)
Men and women aged 18 years and older, after 80 years with caution (Version 2.0)
Verified diagnosis of ischemic stroke (from 5 to 25 points on the NIHSS scale). (Version 1.0)
Verified diagnosis of ischemic stroke (Version 2.0)
The time from the onset of the disease is no more than 4.5 hours.
Informed consent received

Exclusion criteria

Exclusion Criteria:

The time of the onset of the first symptoms is more than 4.5 hours from the onset of the disease or the time of the onset of the first symptoms of a stroke is not known (for example, the development of a stroke during sleep - the so-called "night stroke").
Increased sensitivity to alteplase, gentamicin (residual traces from the production process).
Systolic blood pressure above 185 mm Hg. Art. Or diastolic blood pressure above 110 mm Hg. Art. Or the need for / in the administration of drugs to reduce blood pressure to these boundaries.
Neuroimaging (CT, MRI) signs of intracranial hemorrhage, brain tumors, arteriovenous malformation, brain abscess, aneurysm of cerebral vessels.
Surgery on the brain or spinal cord.
Suspicion of subarachnoid hemorrhage.
Signs of severe stroke: clinical signs (stroke scale NIH> 25), neuroimaging (according to CT of the brain and / or MRI of the brain in the DWI, the ischemia focuses on the territory of more than 1/3 of the CMA pool).
Simultaneous reception of oral anticoagulants, for example, warfarin with INR> 1.3.
The use of direct anticoagulants (heparin, heparinoids) in the preceding stroke of 48 h with APTT values above the norm.
Prior stroke or severe head injury within 3 months.
Significant regression of neurological symptoms during the observation of the patient.(Version 1.0)
Light neurological symptoms (NIH \<4 points). (Version 1.0)
Significant regression of neurological symptoms during the observation of the patient before thrombolisis (Version 2.0)
Hemorrhagic stroke or stroke, unspecified in history.
Strokes of any genesis in the history of a patient with diabetes mellitus.
Gastrointestinal bleeding or bleeding from the genitourinary system in the last 3 weeks. Confirmed exacerbations of gastric ulcer and duodenal ulcer during the last 3 months.
Extensive bleeding now or within the previous 6 months.
Severe liver disease, including liver failure, cirrhosis, portal hypertension (with varicose veins of the esophagus), active hepatitis.
Acute pancreatitis.
Bacterial endocarditis, pericarditis.
Aneurysms of arteries, malformations of arteries and veins. Suspicion of exfoliating aortic aneurysm.
Neoplasms with an increased risk of bleeding.
Large operations or severe injuries within the last 14 days, minor surgery or invasive manipulation in the last 10 days.
Puncture of uncompensated arteries and veins during the last 7 days.
Prolonged or traumatic cardiopulmonary resuscitation (more than 2 min).
Pregnancy, obstetrics, 10 days after birth.
The number of platelets is less than 100,000 / μL.
Blood glucose less than 2.7 mmol / l or more than 22.0 mmol / l.
Hemorrhagic diathesis, including renal and hepatic insufficiency.
Data on bleeding or acute trauma (fracture) at the time of examination.
Seizures in the onset of the disease, if there is no certainty that the seizure is a clinical manifestation of ischemic stroke with a postictal residual deficiency.

Study design

Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 336 participants (actual)

Study arms

Experimental
Recombinant staphylokinase
Lyophilizate for solution making for intravenous injection, 5 mg (745000 ME). 10 mg of drug reconstituted in 10 ml of 0.9% solution of NaCl given as single i.v. bolus over 5 - 10 seconds
Drug: Recombinant staphylokinase
Active comparator
Actilyse
Intravenous alteplase 0.9 mg/kg (10% bolus and 90% as IV infusion over 1 hour, maximum 90 mg)
Drug: Alteplase

Interventions

DrugRecombinant staphylokinase
10 mg of drug reconstituted in 10 ml of 0.9% solution of NaCl given as single i.v. bolus over 5 - 10 seconds
Also known as: Fortelyzin
DrugAlteplase
Intravenous alteplase 0.9 mg/kg (10% bolus and 90% as IV infusion over 1 hour, maximum 90 mg)
Also known as: Actilyse

What researchers measure

Primary outcomes

Good Functional Recovery
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.
Time frame: within 90 days after fibrinolysis

Secondary outcomes

The Number of Patients With Modified Rankin Scale (0-1) + NIHSS (0-1) + Barthel (95-100)
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.
Time frame: within 90 days after fibrinolysis
The Median of NIHSS 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.
Time frame: after 24 hours
The Median of NIHSS After 90 Days
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.
Time frame: within 90 days after fibrinolysis
All Cause Death
Death caused by any event
Time frame: within 90 days after fibrinolysis
Intracranial Haemorrhage
The number of intracranial hemorrhage (events)
Time frame: within 90 days after fibrinolysis
Symptomatic Intracranial Haemorrhage
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.
Time frame: within 90 days after fibrinolysis

Results

Posted Apr 2, 2025

Participant flow

Participant flow — Overall Study
Milestone	Recombinant Staphylokinase	Actilyse
Started	168	168
Completed	168	168
Not completed	0	0

Outcome measures

PrimaryGood Functional Recovery

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.

Time frame:: within 90 days after fibrinolysis
Reported as:: Number · patients

Good Functional Recovery
patients	Recombinant Staphylokinase	Actilyse
Good Functional Recovery	84	68

Statistical analysis

Recombinant Staphylokinase vs Actilyse · Welch's t-test · p = <0.01 · Odds ratio (or): 9.5 · 95% CI -1.7 to 20.7

SecondaryThe Number of Patients With Modified Rankin Scale (0-1) + NIHSS (0-1) + Barthel (95-100)

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.

Time frame:: within 90 days after fibrinolysis
Reported as:: Number · patients

The Number of Patients With Modified Rankin Scale (0-1) + NIHSS (0-1) + Barthel (95-100)
patients	Recombinant Staphylokinase	Actilyse
The Number of Patients With Modified Rankin Scale (0-1) + NIHSS (0-1) + Barthel (95-100)	59	52

SecondaryThe Median of NIHSS 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.

Time frame:: after 24 hours
Reported as:: Median · score

The Median of NIHSS After 24 Hours
score	Recombinant Staphylokinase	Actilyse
The Median of NIHSS After 24 Hours	6 (3 to 11)	6 (3 to 12)

SecondaryThe Median of NIHSS After 90 Days

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.

Time frame:: within 90 days after fibrinolysis
Reported as:: Median · score

The Median of NIHSS After 90 Days
score	Recombinant Staphylokinase	Actilyse
The Median of NIHSS After 90 Days	2 (1 to 5)	2 (1 to 5)

SecondaryAll Cause Death

Death caused by any event

Time frame:: within 90 days after fibrinolysis
Reported as:: Number · patients

All Cause Death
patients	Recombinant Staphylokinase	Actilyse
All Cause Death	17	24

SecondaryIntracranial Haemorrhage

The number of intracranial hemorrhage (events)

Time frame:: within 90 days after fibrinolysis
Reported as:: Number · events

Intracranial Haemorrhage
events	Recombinant Staphylokinase	Actilyse
Intracranial Haemorrhage	31	28

SecondarySymptomatic Intracranial Haemorrhage

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.

Time frame:: within 90 days after fibrinolysis
Reported as:: Number · events

Symptomatic Intracranial Haemorrhage
events	Recombinant Staphylokinase	Actilyse
Symptomatic Intracranial Haemorrhage	5	13

Adverse events

Collected over 90 days after fibronolysis. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Recombinant Staphylokinase	17/168 (10.1%)	22/168 (13.1%)	7/168 (4.2%)
Actilyse	24/168 (14.3%)	38/168 (22.6%)	8/168 (4.8%)

Most frequent serious events

Most frequent serious events
Event	Recombinant Staphylokinase	Actilyse
Cerebral oedemaNervous system disorders	7/168	14/168
Symptomatic intracranial haemorrhageNervous system disorders	5/168	13/168
SurgeryNervous system disorders	5/168	3/168
Pulmonary thromboembolismBlood and lymphatic system disorders	1/168	3/168
NeurosurgeryNervous system disorders	2/168	1/168
Gastric ulcerGastrointestinal disorders	0/168	2/168
Acute myocardial infarctionCardiac disorders	1/168	1/168
New acute ischaemic strokeNervous system disorders	1/168	0/168
Takotsubo cardiomyopathyCardiac disorders	0/168	1/168

Most frequent other events

Most frequent other events
Event	Recombinant Staphylokinase	Actilyse
HaematuriaRenal and urinary disorders	7/168	8/168

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)	Recombinant Staphylokinase	Actilyse	Total
<=18 years	0	0	0
Between 18 and 65 years	84	80	164
>=65 years	84	88	172

Age, Continuous
Age, Continuous(years)	Recombinant Staphylokinase	Actilyse	Total
Mean	64.4 ± 9.6	64.6 ± 10.6	64.5 ± 10.1

Sex: Female, Male
Sex: Female, Male(Participants)	Recombinant Staphylokinase	Actilyse	Total
Female	106	112	218
Male	62	56	118

Race and Ethnicity Not Collected
Race and Ethnicity Not Collected(Participants)	Recombinant Staphylokinase	Actilyse	Total
Count of participants	—	—	0

Region of Enrollment
Region of Enrollment(Participants)	Recombinant Staphylokinase	Actilyse	Total
Russia	168	168	336

Baseline NIHSS score
Baseline NIHSS score(score)	Recombinant Staphylokinase	Actilyse	Total
Median	11 (8 to 14)	11 (8 to 16)	11 (8 to 15)

Baseline mRS score
Baseline mRS score(score)	Recombinant Staphylokinase	Actilyse	Total
Median	4 (4 to 5)	4 (4 to 5)	4 (4 to 5)

Study locations

18 sites

Regional Clinical Hospital
Barnaul, 656024, Russian Federation
St.Iosaf's Belgorod Regional Clinical Hospital
Belgorod, 308007, Russian Federation
Regional Clinical Hospital №3
Chelyabinsk, 454021, Russian Federation
Regional Clinical Hospital №1
Ekaterinburg, 620014, Russian Federation
Regional Clinical Hospital
Irkutsk, 664079, Russian Federation
Regional Clinical Hospital
Kaluga, 248007, Russian Federation
Ochapowski Regional Hospital №1
Krasnodar, 350086, Russian Federation
Regional Clinical Hospital
Kursk, 305007, Russian Federation
Regional Clinical Hospital
Nizhny Novgorod, 603126, Russian Federation
Regional Clinical Hospital
Orenburg, 460018, Russian Federation
City Clinical Hospital №11
Ryazan', 390000, Russian Federation
Regional Clinical Hospital
Ryazan, 390039, Russian Federation
Regional Clinical Hospital
Samara, 443095, Russian Federation
Regional Clinical Hospital
Sankt-peterburg, 194291, Russian Federation
Regional Clinical Hospital
Tver, 170036, Russian Federation
Regional Clinical Hospital
Ulyanovsk, 432017, Russian Federation
City Clinical Hospital of Emergency №25
Volgograd, 400138, Russian Federation
Regional Clinical Hospital №1
Voronezh, 394066, Russian Federation

References and documents

Publications

Armstrong PW, Gershlick A, Goldstein P, Wilcox R, Danays T, Bluhmki E, Van de Werf F; STREAM Steering Committee. The Strategic Reperfusion Early After Myocardial Infarction (STREAM) study. Am Heart J. 2010 Jul;160(1):30-35.e1. doi: 10.1016/j.ahj.2010.04.007. PubMed 20598969 ↗
Van de Werf F, Cannon CP, Luyten A, Houbracken K, McCabe CH, Berioli S, Bluhmki E, Sarelin H, Wang-Clow F, Fox NL, Braunwald E. Safety assessment of single-bolus administration of TNK tissue-plasminogen activator in acute myocardial infarction: the ASSENT-1 trial. The ASSENT-1 Investigators. Am Heart J. 1999 May;137(5):786-91. doi: 10.1016/s0002-8703(99)70400-x. PubMed 10220625 ↗
Assessment of the Safety and Efficacy of a New Thrombolytic (ASSENT-2) Investigators; Van De Werf F, Adgey J, Ardissino D, Armstrong PW, Aylward P, Barbash G, Betriu A, Binbrek AS, Califf R, Diaz R, Fanebust R, Fox K, Granger C, Heikkila J, Husted S, Jansky P, Langer A, Lupi E, Maseri A, Meyer J, Mlczoch J, Mocceti D, Myburgh D, Oto A, Paolasso E, Pehrsson K, Seabra-Gomes R, Soares-Piegas L, Sugrue D, Tendera M, Topol E, Toutouzas P, Vahanian A, Verheugt F, Wallentin L, White H. Single-bolus tenecteplase compared with front-loaded alteplase in acute myocardial infarction: the ASSENT-2 double-blind randomised trial. Lancet. 1999 Aug 28;354(9180):716-22. doi: 10.1016/s0140-6736(99)07403-6. PubMed 10475182 ↗
Assessment of the Safety and Efficacy of a New Thrombolytic Regimen (ASSENT)-3 Investigators. Efficacy and safety of tenecteplase in combination with enoxaparin, abciximab, or unfractionated heparin: the ASSENT-3 randomised trial in acute myocardial infarction. Lancet. 2001 Aug 25;358(9282):605-13. doi: 10.1016/S0140-6736(01)05775-0. PubMed 11530146 ↗
Wallentin L, Goldstein P, Armstrong PW, Granger CB, Adgey AA, Arntz HR, Bogaerts K, Danays T, Lindahl B, Makijarvi M, Verheugt F, Van de Werf F. Efficacy and safety of tenecteplase in combination with the low-molecular-weight heparin enoxaparin or unfractionated heparin in the prehospital setting: the Assessment of the Safety and Efficacy of a New Thrombolytic Regimen (ASSENT)-3 PLUS randomized trial in acute myocardial infarction. Circulation. 2003 Jul 15;108(2):135-42. doi: 10.1161/01.CIR.0000081659.72985.A8. Epub 2003 Jul 7. PubMed 12847070 ↗
Vanderschueren S, Dens J, Kerdsinchai P, Desmet W, Vrolix M, De Man F, Van den Heuvel P, Hermans L, Collen D, Van de Werf F. Randomized coronary patency trial of double-bolus recombinant staphylokinase versus front-loaded alteplase in acute myocardial infarction. Am Heart J. 1997 Aug;134(2 Pt 1):213-9. doi: 10.1016/s0002-8703(97)70127-3. PubMed 9313600 ↗
Collaborative Research Group of Reperfusion Therapy in Acute Myocardial Infarction. [A randomized multicenter trial comparing recombinant staphylokinase with recombinant tissue-type plasminogen activator in patients with acute myocardial infarction]. Zhonghua Xin Xue Guan Bing Za Zhi. 2007 Aug;35(8):691-6. Chinese. PubMed 17963623 ↗
Collen D. Staphylokinase: a potent, uniquely fibrin-selective thrombolytic agent. Nat Med. 1998 Mar;4(3):279-84. doi: 10.1038/nm0398-279. No abstract available. PubMed 9500599 ↗
Wahlgren N, Ahmed N, Eriksson N, Aichner F, Bluhmki E, Davalos A, Erila T, Ford GA, Grond M, Hacke W, Hennerici MG, Kaste M, Kohrmann M, Larrue V, Lees KR, Machnig T, Roine RO, Toni D, Vanhooren G; Safe Implementation of Thrombolysis in Stroke-MOnitoring STudy Investigators. Multivariable analysis of outcome predictors and adjustment of main outcome results to baseline data profile in randomized controlled trials: Safe Implementation of Thrombolysis in Stroke-MOnitoring STudy (SITS-MOST). Stroke. 2008 Dec;39(12):3316-22. doi: 10.1161/STROKEAHA.107.510768. Epub 2008 Oct 16. PubMed 18927461 ↗
Hacke W, Kaste M, Fieschi C, von Kummer R, Davalos A, Meier D, Larrue V, Bluhmki E, Davis S, Donnan G, Schneider D, Diez-Tejedor E, Trouillas P. Randomised double-blind placebo-controlled trial of thrombolytic therapy with intravenous alteplase in acute ischaemic stroke (ECASS II). Second European-Australasian Acute Stroke Study Investigators. Lancet. 1998 Oct 17;352(9136):1245-51. doi: 10.1016/s0140-6736(98)08020-9. PubMed 9788453 ↗
Clark WM, Wissman S, Albers GW, Jhamandas JH, Madden KP, Hamilton S. Recombinant tissue-type plasminogen activator (Alteplase) for ischemic stroke 3 to 5 hours after symptom onset. The ATLANTIS Study: a randomized controlled trial. Alteplase Thrombolysis for Acute Noninterventional Therapy in Ischemic Stroke. JAMA. 1999 Dec 1;282(21):2019-26. doi: 10.1001/jama.282.21.2019. PubMed 10591384 ↗
Hacke W, Kaste M, Bluhmki E, Brozman M, Davalos A, Guidetti D, Larrue V, Lees KR, Medeghri Z, Machnig T, Schneider D, von Kummer R, Wahlgren N, Toni D; ECASS Investigators. Thrombolysis with alteplase 3 to 4.5 hours after acute ischemic stroke. N Engl J Med. 2008 Sep 25;359(13):1317-29. doi: 10.1056/NEJMoa0804656. PubMed 18815396 ↗
Gusev EI, Martynov MY, Nikonov AA, Shamalov NA, Semenov MP, Gerasimets EA, Yarovaya EB, Semenov AM, Archakov AI, Markin SS; FRIDA Study Group. Non-immunogenic recombinant staphylokinase versus alteplase for patients with acute ischaemic stroke 4.5 h after symptom onset in Russia (FRIDA): a randomised, open label, multicentre, parallel-group, non-inferiority trial. Lancet Neurol. 2021 Sep;20(9):721-728. doi: 10.1016/S1474-4422(21)00210-6. PubMed 34418399 ↗

Study documents

Protocol and statistical analysis plan · Jul 15, 2016

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Apr 2, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT03151993
Lead sponsor: Supergene, LLC
Responsible party: Sponsor
First posted: May 12, 2017
Start date: Mar 18, 2017
Primary completion: Mar 23, 2019
Completion: Jun 20, 2019
Results posted: Apr 2, 2025
Last update: Apr 2, 2025

Study contacts

Evgenii I Gusev, MD, PhD

principal investigator · Pirogov Russian National Research Medical University

Sergey S Markin, MD, PhD

study director · Supergene, LLC

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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