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

Recruiting now · Phase 3 · Has a placebo group

Conditions studied: Pulmonary Embolism

In brief

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)

Key facts

Study ID

NCT06362746

Run by

Supergene, LLC

People needed

486

Starts

2024-05-23

Expected to finish

2028-12-01

Last updated by the study team

2025-12-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Men and women aged 18 and over.
• Verified diagnosis of intermediate high-risk PE using CTPA, no more than two weeks from the symptoms onset.
• RV dysfunction, defined as a RV/LV ventricular end-diastolic diameter ratio more than 1.0 assessed by CTPA.
• Increased risk of early death or hemodynamic collapse, defined by one of the following criteria:
• systolic blood pressure less than 110 mm Hg, but not less than 90 mm Hg for more than 15 minutes;
• respiratory rate more than 20 per minute or SpO2 less than 90% without oxygen support;
• chronic heart failure with left ventricular ejection fraction less than 40%.
• Serum troponin I level more than 14 pg/mL in patients under 75 years, and more than 45 pg/mL in patients aged 75 years or older.
• Patient consent to use reliable contraceptive methods throughout the study and for 3 weeks after:
• women who have a negative pregnancy test and use the following contraceptives: intrauterine devices, oral contraceptives, contraceptive patch, prolonged injectable contraceptives, double barrier method of contraception. Women who are not fertile can also take part in the study (documented conditions: hysterectomy, tubal ligation, infertility, menopause for more than 1 year);
• men using barrier contraception. The study may also involve men who are not fertile (documented conditions: vasectomy, infertility).
• Availability of signed and dated informed consent of the patient to participate in the study.

You may not qualify if…

• High-risk PE with hemodynamic instability.
• Increased risk of bleeding:
• extensive bleeding at present or within the previous 6 months;
• intracranial (including subarachnoid) hemorrhage at present or in history;
• hemorrhagic stroke within the last 6 months;
• a history of diseases of the central nervous system (including neoplasms, aneurysms);
• intracranial or spinal surgical interventions within the last 2 months;
• major surgery or major trauma within the previous 4 weeks;
• recent puncture of an incompressible blood vessel (eg, subclavian or jugular vein);
• severe liver disease, including liver failure, cirrhosis, portal hypertension (including esophageal varices) and active hepatitis;
• confirmed gastric or duodenal ulcer within the last 3 months;
• neoplasm with an increased risk of bleeding;
• simultaneous administration of Dabigatran without prior administration of idarucizumab;
• arterial aneurysms, developmental defects of arteries / veins;
• acute pancreatitis;
• bacterial endocarditis, pericarditis;
• suspicion of aortic dissecting aneurysm;
• any other conditions, in the opinion of the investigator, associated with a high risk of bleeding.
• Lactation, pregnancy.
• Known hypersensitivity to the non-immunogenic recombinant staphylokinase.

Where it is running

• City Clinical Hospital of Emergency medicine №25 — Volgograd, Russia (enrolling)
• V.F. Dolgopolov Vyselki Central District Hospital — Vyselki, Krasnodarskiy Kray, Russia (enrolling)
• Tver Regional Clinical Hospital — Tver', Russia (enrolling)
• Ufa Emergency City Hospital — Ufa, Russia (enrolling)
• RZD Medicine hospital — Barnaul, Altayskiy Kray, Russia (enrolling)
• Belgorod Regional Clinical Hospital of St. Joseph — Belgorod, Russia (enrolling)
• Kuzbass Cardiology center — Kemerovo, Russia (enrolling)
• Center of Neurology and Cardiology — Kirov, Russia (enrolling)
• Regional Clinical Hospital №2 — Krasnodar, Russia (enrolling)
• Lipetsk City Hospital No. 4 "Lipetsk-Med" — Lipetsk, Russia (enrolling)
• F.I. Inozemtsev City Clinical Hospital — Moscow, Russia (enrolling)
• Moscow Multidisciplinary Clinical Center "Kommunarka" — Moscow, Russia (enrolling)
• S.S. Yudin City Clinical Hospital — Moscow, Russia (enrolling)
• V.M. Buyanov City Clinical Hospital — Moscow, Russia (enrolling)
• S.P. Botkin City Clinical Hospital — Moscow, Russia (enrolling)
• N.A. Semashko Nizhny Novgorod Regional Clinical Hospital — Nizhny Novgorod, Russia (enrolling)
• G.A. Zakharyin Clinical hospital №6 — Penza, Russia (enrolling)
• City Hospital No. 26 — Saint Petersburg, Russia (enrolling)
• City Hospital No. 15 — Saint Petersburg, Russia (enrolling)
• V.P. Polyakov Samara Regional Clinical Cardiology Dispensary — Samara, Russia (enrolling)
• Tomsk regional cilinical hospital — Tomsk, Russia (enrolling)
• Asinovskaya District Hospital — Asino, Tomsk Oblast, Russia
• City Clinical Hospital №4 — Perm, Russia
• N.N. Burdenko Penza Regional Clinical hospital — Penza, Russia

Full record on ClinicalTrials.gov

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