Massive Pulmonary Embolism: Trial of Non-immunogenic Recombinant Staphylokinase VS Alteplase FORPE

PHASE3CompletedINTERVENTIONAL
Enrollment

310

Participants

Timeline

Start Date

December 15, 2020

Primary Completion Date

July 27, 2023

Study Completion Date

July 27, 2023

Conditions
Massive Pulmonary Embolism
Interventions
DRUG

Recombinant nonimmunogenic staphylokinase

15 mg of drug reconstituted in 10 ml of 0.9% solution of NaCl given as single i.v. bolus over 10-15 seconds

DRUG

Alteplase

Alteplase® is administered in accordance with the instructions for use for pulmonary embolism ( 10 mg bolus and 90 mg as IV infusion over 2 hours, maximum 100 mg). In patients weighing less than 65 kg, the total dose should not exceed 1.5 mg / kg.

Trial Locations (23)

105077

D.D. Pletnev City Clinical Hospital, Moscow

109240

I.V. Davydovskii City Clinical Hospital, Moscow

115446

S.S. Yudin City Clinical Hospital, Moscow

117292

V.V. Vinogradov City Clinical Hospital, Moscow

127644

V.V. Veresaev City Clinical Hospital, Moscow

129090

N.V. Sklifosovsky Research Institute for Emergency Medicine, Moscow

141301

Sergiyev Posad Regional Clinical Hospital, Sergiyev Posad

170036

Tver Regional Clinical Hospital, Tver'

183047

Murmansk Regional Clinical Hospital, Murmansk

191014

"Saint Petersburg Mariinskaya City Hospital", Saint Petersburg

195257

Holy Martyr Elizabeth Saint Petersburg City Hospital, Saint Petersburg

305007

Kursk Regional Clinical Hospital, Kursk

308007

Belgorod Regional Clinical Hospital of St. Joseph, Belgorod

353100

V.F. Dolgopolov Vyselki Central District Hospital, Vyselki

400138

City Clinical Hospital of Emergency №25, Volgograd

410039

Saratov Regional Clinical Cardiology Dispensary, Saratov

440026

N.N. Burdenko Penza Regional Clinical hospital, Penza

440071

G.A. Zakharyin Clinical hospital №6, Penza

443070

V.P. Polyakov Samara Regional Clinical Cardiology Dispensary, Samara

600009

City Clinical hospital №4, Vladimir

650002

Kuzbass Cardiology center, Kemerovo

660022

Krasnoyarsk Regional Clinical Hospital, Krasnoyarsk

Unknown

S.P. Botkin City Clinical Hospital, Moscow

All Listed Sponsors
lead

Supergene, LLC

INDUSTRY

NCT04688320 - Massive Pulmonary Embolism: Trial of Non-immunogenic Recombinant Staphylokinase VS Alteplase FORPE | Biotech Hunter | Biotech Hunter