Ischemic Stroke Clinical Trial
Official title:
Multicenter Open Label Randomized Comparative Study of Efficacy and Safety of Single Bolus Injection of Recombinant Nonimmunogenic Staphylokinase (Fortelyzin) and Bolus Infusion Alteplase (Actilyse) in Patients With Acute Ischemic Stroke
Verified date | September 2020 |
Source | Supergene, LLC |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 336 |
Est. completion date | June 20, 2019 |
Est. primary completion date | March 23, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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: - 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. |
Country | Name | City | State |
---|---|---|---|
Russian Federation | Regional Clinical Hospital | Barnaul | |
Russian Federation | St.Iosaf's Belgorod Regional Clinical Hospital | Belgorod | |
Russian Federation | Regional Clinical Hospital ?3 | Chelyabinsk | |
Russian Federation | Regional Clinical Hospital ?1 | Ekaterinburg | |
Russian Federation | Regional Clinical Hospital | Irkutsk | |
Russian Federation | Regional Clinical Hospital | Kaluga | |
Russian Federation | Ochapowski Regional Hospital ?1 | Krasnodar | |
Russian Federation | Regional Clinical Hospital | Kursk | |
Russian Federation | Regional Clinical Hospital | Nizhny Novgorod | |
Russian Federation | Regional Clinical Hospital | Orenburg | |
Russian Federation | Regional Clinical Hospital | Ryazan | |
Russian Federation | City Clinical Hospital ?11 | Ryazan' | |
Russian Federation | Regional Clinical Hospital | Samara | |
Russian Federation | Regional Clinical Hospital | Sankt-peterburg | |
Russian Federation | Regional Clinical Hospital | Tver | |
Russian Federation | Regional Clinical Hospital | Ulyanovsk | |
Russian Federation | City Clinical Hospital of Emergency ?25 | Volgograd | |
Russian Federation | Regional Clinical Hospital ?1 | Voronezh |
Lead Sponsor | Collaborator |
---|---|
Supergene, LLC |
Russian Federation,
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. — View Citation
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, Heikkilä 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, Sùgrue 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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
Collen D. Staphylokinase: a potent, uniquely fibrin-selective thrombolytic agent. Nat Med. 1998 Mar;4(3):279-84. Review. — View Citation
Hacke W, Kaste M, Bluhmki E, Brozman M, Dávalos 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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
Wahlgren N, Ahmed N, Eriksson N, Aichner F, Bluhmki E, Dávalos A, Erilä T, Ford GA, Grond M, Hacke W, Hennerici MG, Kaste M, Köhrmann 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. — View Citation
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* Note: There are 12 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Good functional recovery | Good functional recovery on the 90th day (modified Rankin scale, 0-1 point). | within 90 days after fibrinolysis | |
Secondary | Modified Rankin scale (0-1) + NIHSS (0-1) + Barthel (95-100) | Composite endpoint | within 90 days after fibrinolysis | |
Secondary | NIHSS | NIHSS after 24 hours | after 24 hours | |
Secondary | NIHSS | NIHSS after 90 days | within 90 days after fibrinolysis | |
Secondary | All Cause Death | Death caused by any event | within 90 days after fibrinolysis | |
Secondary | Hemorrhagic transformation | Hemorrhagic transformation (all cases). | within 90 days after fibrinolysis | |
Secondary | Symptomatic hemorrhagic transformation | Increase in NIHSS index by 4 points or more or death | within 90 days after fibrinolysis | |
Secondary | Serious adverse reactions and adverse reactions | Serious adverse reactions and adverse reactions (all cases) | within 90 days after fibrinolysis |
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