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RECRUITING
NCT06362746
PHASE3

Non-immunogenic Recombinant Staphylokinase vs Placebo in Patients With Intermediate High-risk Pulmonary Embolism

Sponsor: Supergene, LLC

View on ClinicalTrials.gov

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

Interventions

DRUG

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

DRUG

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