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Non-immunogenic Recombinant Staphylokinase vs Placebo in Patients With Intermediate High-risk Pulmonary Embolism
Sponsor: Supergene, LLC
Summary
Objective: to evaluate the efficacy and safety of the non-immunogenic recombinant staphylokinase with its single bolus administration in comparison with placebo in normotensive patients with intermediate high-risk pulmonary embolism (PE)
Official title: Multicenter, Double-blind, Randomized, Placebo-controlled Trial of the Efficacy and Safety of a Single Bolus Administration of Non-immunogenic Recombinant Staphylokinase in Patients With Intermediate High-risk Pulmonary Embolism (FORPE-2)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
486
Start Date
2024-05-23
Completion Date
2028-12-01
Last Updated
2025-12-05
Healthy Volunteers
No
Conditions
Interventions
Non-immunogenic recombinant staphylokinase
15 mg of drug reconstituted in 15 ml of 0.9% solution of NaCl given as single i.v. bolus over 10-15 seconds
Placebo
15 mg of placebo reconstituted in 15 ml of 0.9% solution of NaCl given as single i.v. bolus over 10-15 seconds
Locations (24)
RZD Medicine hospital
Barnaul, Altayskiy Kray, Russia
V.F. Dolgopolov Vyselki Central District Hospital
Vyselki, Krasnodarskiy Kray, Russia
Asinovskaya District Hospital
Asino, Tomsk Oblast, Russia
Belgorod Regional Clinical Hospital of St. Joseph
Belgorod, Russia
Kuzbass Cardiology center
Kemerovo, Russia
Center of Neurology and Cardiology
Kirov, Russia
Regional Clinical Hospital №2
Krasnodar, Russia
Lipetsk City Hospital No. 4 "Lipetsk-Med"
Lipetsk, Russia
F.I. Inozemtsev City Clinical Hospital
Moscow, Russia
Moscow Multidisciplinary Clinical Center "Kommunarka"
Moscow, Russia
S.S. Yudin City Clinical Hospital
Moscow, Russia
V.M. Buyanov City Clinical Hospital
Moscow, Russia
S.P. Botkin City Clinical Hospital
Moscow, Russia
N.A. Semashko Nizhny Novgorod Regional Clinical Hospital
Nizhny Novgorod, Russia
N.N. Burdenko Penza Regional Clinical hospital
Penza, Russia
G.A. Zakharyin Clinical hospital №6
Penza, Russia
City Clinical Hospital №4
Perm, Russia
City Hospital No. 26
Saint Petersburg, Russia
City Hospital No. 15
Saint Petersburg, Russia
V.P. Polyakov Samara Regional Clinical Cardiology Dispensary
Samara, Russia
Tomsk regional cilinical hospital
Tomsk, Russia
Tver Regional Clinical Hospital
Tver', Russia
Ufa Emergency City Hospital
Ufa, Russia
City Clinical Hospital of Emergency medicine №25
Volgograd, Russia