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

PHASE3CompletedINTERVENTIONAL
Enrollment

336

Participants

Timeline

Start Date

March 18, 2017

Primary Completion Date

March 23, 2019

Study Completion Date

June 20, 2019

Conditions
Ischemic Stroke
Interventions
DRUG

Recombinant 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

DRUG

Alteplase

Intravenous alteplase 0.9 mg/kg (10% bolus and 90% as IV infusion over 1 hour, maximum 90 mg)

Trial Locations (18)

170036

Regional Clinical Hospital, Tver'

194291

Regional Clinical Hospital, Saint Petersburg

248007

Regional Clinical Hospital, Kaluga

305007

Regional Clinical Hospital, Kursk

308007

St.Iosaf's Belgorod Regional Clinical Hospital, Belgorod

350086

Ochapowski Regional Hospital №1, Krasnodar

390000

City Clinical Hospital №11, Ryazan

390039

Regional Clinical Hospital, Ryazan

394066

Regional Clinical Hospital №1, Voronezh

400138

City Clinical Hospital of Emergency №25, Volgograd

432017

Regional Clinical Hospital, Ulyanovsk

443095

Regional Clinical Hospital, Samara

454021

Regional Clinical Hospital №3, Chelyabinsk

460018

Regional Clinical Hospital, Orenburg

603126

Regional Clinical Hospital, Nizhny Novgorod

620014

Regional Clinical Hospital №1, Yekaterinburg

656024

Regional Clinical Hospital, Barnaul

664079

Regional Clinical Hospital, Irkutsk

All Listed Sponsors
lead

Supergene, LLC

INDUSTRY

NCT03151993 - Single Bolus Recombinant Nonimmunogenic Staphylokinase (Fortelyzin) and Bolus Infusion Alteplase in Patients With AIS | Biotech Hunter | Biotech Hunter