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

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ClinicalTrials.gov Identifier: NCT03151993
Recruitment Status : Unknown
Verified May 2017 by Supergene, LLC.
Recruitment status was:  Recruiting
First Posted : May 12, 2017
Last Update Posted : May 12, 2017
Sponsor:
Information provided by (Responsible Party):
Supergene, LLC

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

Condition or disease Intervention/treatment Phase
Ischemic Stroke Drug: Recombinant staphylokinase Drug: Alteplase Phase 3

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 336 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Multicenter Open Lable Randomized Comparative Study of Efficacy and Safety of Single Bolus Injection of Recombinant Nonimmunogenic Staphylokinase (Fortelyzin) and Bolus Infusion Alteplase (Actillyse) in Patients With Ischemic Stroke
Actual Study Start Date : July 15, 2016
Estimated Primary Completion Date : December 27, 2018
Estimated Study Completion Date : December 27, 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Alteplase

Arm Intervention/treatment
Experimental: 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
Drug: 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
Other Name: Fortelyzin

Active Comparator: Actilise
Intravenous alteplase 0.9 mg/kg (10% bolus and 90% as IV infusion over 1 hour, maximum 90 mg)
Drug: Alteplase
Intravenous alteplase 0.9 mg/kg (10% bolus and 90% as IV infusion over 1 hour, maximum 90 mg)
Other Name: Actilise




Primary Outcome Measures :
  1. Good functional recovery [ Time Frame: within 90 days after fibrinolysis ]
    Good functional recovery on the 90th day (modified Rankin scale, 0-1 point).


Secondary Outcome Measures :
  1. Modified Rankin scale + NIHSS + Barthel [ Time Frame: within 90 days after fibrinolysis ]
    Composite endpoint

  2. NIHSS [ Time Frame: after 24 hours ]
    NIHSS after 24 hours

  3. NIHSS [ Time Frame: after 90 days ]
    NIHSS after 90 days

  4. All Cause Death [ Time Frame: within 90 days after fibrinolysis ]
    Death caused by any event

  5. Hemorrhagic transformation [ Time Frame: within 90 days after fibrinolysis ]
    Hemorrhagic transformation (all cases).

  6. Symptomatic hemorrhagic transformation [ Time Frame: within 90 days after fibrinolysis ]
    Increase in NIHSS index by 4 points or more or death



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Men and women between the ages of 18 and 80
  • Verified diagnosis of ischemic stroke (from 5 to 25 points on the NIHSS scale).
  • The time from the onset of the disease is no more than 4.5 hours.
  • Informed consent received

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.
  • Light neurological symptoms (NIH <4 points).
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03151993


Contacts
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Contact: Evgenii I Gusev, MD, Prof +79104673663 m-martin@inbox.ru

Locations
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Russian Federation
Regional Clinical Hospital Not yet recruiting
Ryazan, Russian Federation, 390039
Contact: Sergey B Aksentiev, MD, PhD    4912214152 ext +7    aksentiev@mail.ru   
Principal Investigator: Sergey B Aksentiev, MD, PhD         
Regional Clinical Hospital Recruiting
Tver, Russian Federation, 170036
Contact: Dmitriy Yu Platonov, MD, PhD    4822555878 ext +7    diplato64@mail.ru   
Principal Investigator: Dmitriy Yu Platonov, MD, PhD         
Citi Clinical Hospital # 4 Not yet recruiting
Vladimir, Russian Federation, 600020
Contact: Evena V Kulibaba, MD, PhD    4922535071 ext +7    kulibaba@pochta.ru   
Principal Investigator: Evena V Kulibaba, MD,PhD         
City Clinical Hospital of Emergency #25 Recruiting
Volgograd, Russian Federation, 400138
Contact: Eduard A Ponomarev, MD, PhD    8442585426 ext +7    ponomarev67@mail.ru   
Principal Investigator: Eduard A Ponomarev, MD, PhD         
Sponsors and Collaborators
Supergene, LLC
Investigators
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Principal Investigator: Evgenii I Gusev, MD, Prof Department of Neurology and Neurosurgery, N. M. Pirogov Russian National Research Medical University, Moscow
Study Director: Sergey S Markin, MD, Prof Supergene LSS

Additional Information:
Publications:

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Responsible Party: Supergene, LLC
ClinicalTrials.gov Identifier: NCT03151993     History of Changes
Other Study ID Numbers: FRIDA Stroke Trial
First Posted: May 12, 2017    Key Record Dates
Last Update Posted: May 12, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Supergene, LLC:
Ischemic Stroke
Fibrinolysis
Fortelyzin

Additional relevant MeSH terms:
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Stroke
Ischemia
Cerebral Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Brain Infarction
Brain Ischemia
Tissue Plasminogen Activator
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action