Single Bolus Recombinant Nonimmunogenic Staphylokinase Versus Single Bolus Tenecteplase (Metalyse) in STEMI

PHASE3CompletedINTERVENTIONAL
Enrollment

382

Participants

Timeline

Start Date

May 16, 2014

Primary Completion Date

December 1, 2016

Study Completion Date

December 1, 2016

Conditions
Myocardial Infarction
Interventions
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

DRUG

Tenecteplase

"50 mg of drug reconstituted in 10 ml sterile water for injection given as single weight-adjusted i.v. bolus over 5 - 10 seconds Weight (kg) Dose (mg) Dose (ml)~* 55 to \<60 30 mg 6 ml~* 60 to \<70 35 mg 7 ml~* 70 to \<80 40 mg 8 ml"

Trial Locations (17)

117997

Russian national research medical University named after Pirogov, Moscow

127644

City Clinical Hospital #81, Moscow

129090

The Sklifosovsky Research institute of Emergency, Moscow

170036

Regional Clinical Hospital, Tver'

183047

Murmansk Regional Clinical Hospital, Murmansk

191014

Mariinsk City Hospital, Saint Petersburg

194291

Leningrad Regional Clinical Hospital, Saint Petersburg

308007

St. Iosaf's Belgorod Regional Clinical Hospital, Belgorod

390039

Regional Clinical Hospital, Ryazan

400138

City Clinical Hospital of Emergency #25, Volgograd

600020

Citi Clinical Hospital # 4, Vladimir

603005

City Clinical Hospital #5, Nizhny Novgorod

634012

Institute of Cardiology, Tomsk

650002

Kemerovo cardiological dispensary, Kemerovo

Research Institute of Complex Problems of Cardiovascular diseases, Kemerovo

650014

City Clinical Hospital #11, Kemerovo

44З070

Samara Regional Clinical Cardiological Dispansery, Samara

All Listed Sponsors
lead

Supergene, LLC

INDUSTRY

NCT02301910 - Single Bolus Recombinant Nonimmunogenic Staphylokinase Versus Single Bolus Tenecteplase (Metalyse) in STEMI | Biotech Hunter | Biotech Hunter