Non-immunogenic Recombinant Staphylokinase vs Placebo in Patients With Intermediate High-risk Pulmonary Embolism
NCT ID: NCT06362746
Last Updated: 2025-12-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
486 participants
INTERVENTIONAL
2024-05-23
2028-12-01
Brief Summary
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Detailed Description
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In PEITHO trial tenecteplase, administered as a single bolus at a dose of 30-50 mg depending on body weight was compared with a placebo in patients with intermediate high-risk PE with right ventricular dysfunction. Efficacy of tenecteplase was combined with a significant (6.3%) risk of hemorrhagic stroke, which did not allow tenecteplase to be included in the list of recommended thrombolytics for PE treatment.
PEITHO-3 trial has now begun, in which patients with intermediate high-risk PE are given a reduced dose of alteplase (0.6 mg/kg infusion with the total dose not exceeding 50 mg) compared with placebo.
Staphylokinase is a thrombolytic agent with high biological activity. Amino acid substitutions - including Lys74Ala, Glu75Ala, and Arg77Ala - resulted in a more than 200-times reduction in titres of neutralising antistaphylokinase IgGs in patients with ST-elevation myocardial infarction. In FORPE trial non-immunogenic recombinant staphylokinase was non-inferior as compared with alteplase in patients with high-risk massive PE.
The main objectives of this study: to assess the efficacy, safety and possible adverse events of the non-immunogenic recombinant staphylokinase with its single bolus administration in normotensive patients with intermediate high-risk PE in comparison with placebo.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
Non-immunogenic recombinant staphylokinase or placebo will be administered intravenously at a dose of 15 mg as a single bolus for 10-15 seconds. All patients will be examined for 30 days.
TREATMENT
DOUBLE
Study Groups
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Non-immunogenic recombinant staphylokinase
lyophilisate for preparation of a solution for intravenous administration, 5 mg (745,000 IU) complete with a solvent. 15 mg (2,235,000 IU) - 3 vials, intravenously as a quick single bolus injection for 10-15 seconds, regardless of body weight.
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
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
Interventions
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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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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:
1. systolic blood pressure less than 110 mm Hg, but not less than 90 mm Hg for more than 15 minutes;
2. respiratory rate more than 20 per minute or SpO2 less than 90% without oxygen support;
3. 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.
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Supergene, LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Sergey N. Tereschenko, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
National Medical Research Center for Cardiology, Ministry of Health of Russian Federation
Locations
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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
Countries
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Central Contacts
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Facility Contacts
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Alexander V. Lubavin, PhD
Role: backup
References
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Kirienko AI, Leontyev SG, Tereschenko SN, Yavelov IS, Shakhnovich RM, Erlikh AD, Talibov OB, Yarovaya EB, Semenov AM, Semenov MP, Ivanov SV, Beregovykh VV, Archakov AI, Markin SS; FORPE study group. Non-immunogenic recombinant staphylokinase versus alteplase for patients with massive pulmonary embolism: a randomized open-label, multicenter, parallel-group, non-inferiority trial, FORPE. J Thromb Haemost. 2025 Feb;23(2):657-667. doi: 10.1016/j.jtha.2024.09.035. Epub 2024 Oct 23.
Leontyev SG, Yarovaya EB, Kutsenko VA, Ivlev OE, Soplenkova AG, Semenov AM, Semenov MP, Ivanov SV, Romashova YA, Markin SS. The Safety of Non-immunogenic Recombinant Staphylokinase in Elderly Patients With Massive Pulmonary Embolism: A Randomized Clinical Trial FORPE. Health Sci Rep. 2025 May 19;8(5):e70826. doi: 10.1002/hsr2.70826. eCollection 2025 May.
Other Identifiers
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FORPE-2
Identifier Type: -
Identifier Source: org_study_id
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