180
Participants
Start Date
May 25, 2014
Primary Completion Date
November 21, 2017
Study Completion Date
December 11, 2017
Revelise (GENERIUM, Russia)
"1. 90-minute accelerated dosing regimen for patients who can start treatment within 6 hours after the onset of symptoms of acute myocardial infarction (AMI): Initial bolus injection: 15 mg intraveniously (IV) followed by an infusion of 50 mg over 30 minutes and then a subsequent infusion of 35 mg over 60 minutes to reach a maximum total dose of 100 mg.~ \- For patients less than 65 kg: Initial bolus injection: 15 mg IV - 0.75 mg/kg (maximum 50 mg) over 30 minutes followed by an additional infusion of 0.5 mg/kg (maximum 35 mg) over 60 minutes.~2. 3-hour dosing regimen for patients who can start treatment between 6 and 12 hours after symptom onset of AMI: Initial bolus injection: 10 mg IV followed by an infusion of 50 mg over 60 minutes and then a subsequent infusion of 40 mg over 120 minutes to achieve a maximum total dose of 100 mg.~ * For patients less than 65 kg: The cumulative dose should not exceed 1.5 mg/kg."
Actilyse® (Boehringer Ingelheim Pharma GmbH and Co.KG, Germany)
"1. 90-minute accelerated dosing regimen for patients who can start treatment within 6 hours after the onset of symptoms of acute myocardial infarction (AMI): Initial bolus injection: 15 mg intraveniously (IV) followed by an infusion of 50 mg over 30 minutes and then a subsequent infusion of 35 mg over 60 minutes to reach a maximum total dose of 100 mg.~ \- For patients less than 65 kg: Initial bolus injection: 15 mg IV - 0.75 mg/kg (maximum 50 mg) over 30 minutes followed by an additional infusion of 0.5 mg/kg (maximum 35 mg) over 60 minutes.~2. 3-hour dosing regimen for patients who can start treatment between 6 and 12 hours after symptom onset of AMI: Initial bolus injection: 10 mg IV followed by an infusion of 50 mg over 60 minutes and then a subsequent infusion of 40 mg over 120 minutes to achieve a maximum total dose of 100 mg.~ * For patients less than 65 kg: The cumulative dose should not exceed 1.5 mg/kg."
"SBHI State Budgetary Healthcare Institution of MHD", Moscow
"Moscow City State Budgetary Healthcare Institution Filatov City Clinical Hospital No. 15 of Moscow Healthcare Department", Moscow
"State Budgetary Healthcare Institution of the city of Moscow City Clinical Hospital No. 64 of Moscow Healthcare Department", Moscow
"Federally Funded Higher Education Institution Russian National Research Medical University named after N.I. Pirogov of the Ministry of Health of the Russian Federation", Moscow
"Moscow City State Budgetary Healthcare Institution Botkin City Clinical Hospital of Moscow Healthcare Department", Moscow
"SBHI CCH No. 81 MHD", Moscow
"SBHI Sklifosovsky Research Institute of Emergency Medicine of MHD", Moscow
"City Budgetary Healthcare Institution of Arkhangelsk Region First City Clinical Hospital named after E.E. Volosevich", Arkhangelsk
"SI St. Petersburg Dzhanelidze Research Institute of Emergency Medicine", Saint Petersburg
"St. Petersburg State Budgetary Healthcare Institution Pokrovskaya City Hospital", Saint Petersburg
"Municipal Budgetary Healthcare Institution City Emergency Medical Hospital of Rostov-on-Don", Rostov-on-Don
"SBHI SC Stavropol Regional Clinical Hospital", Stavropol
FSI Saratov Research Institute of Cardiology of Russian medical Technologies, Saratov
"State Healthcare Institution City Clinical Hospital No. 12", Saratov
"FSBEI of HVE Mordovia State University named after N.P. Ogarev, Medical Institute, SBHI MR City Clinical Hospital No. 3", Saransk
SBHI Republican Cardiology Center, Ufa
Municipal Health Care Institution City Clinical Hospital No.4, Perm
"Novosibirsk Region State Budgetary Healthcare Institution City Clinical Hospital No. 1", Novosibirsk
"State Budgetary Healthcare Institution of Novosibirsk City Clinical Hospital No. 2", Novosibirsk
"Novosibirsk Region State Budgetary Healthcare Institution City Clinical Hospital No. 34", Novosibirsk
"Federal State Budgetary Scientific Institution Scientific Research Institute for Complex Issues of Cardiovascular Diseases", Kemerovo
"Regional State Budgetary Healthcare Institution Altai Regional Cardiological Dispensary", Barnaul
AO GENERIUM
INDUSTRY