protocolSection identificationModule nctId: NCT06362746, orgStudyIdInfo id: FORPE-2, briefTitle: Non-immunogenic Recombinant Staphylokinase vs Placebo in Patients With Intermediate High-risk Pulmonary Embolism, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-15, primaryCompletionDateStruct date: 2028-06-01, completionDateStruct date: 2028-12-01, studyFirstPostDateStruct date: 2024-04-12, lastUpdatePostDateStruct date: 2024-04-12, sponsorCollaboratorsModule leadSponsor name: Supergene, LLC, class: INDUSTRY, descriptionModule briefSummary: 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), conditionsModule conditions: Pulmonary Embolism, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: At clinical sites patients will be equally randomized into two groups to receive non-immunogenic recombinant staphylokinase or placebo.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., primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, maskingDescription: Neither patient nor investigator knows treatment assignment. All eligible patients will be randomized in two equal groups for administration of non-immunogenic recombinant staphylokinase or placebo., whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 486, type: ESTIMATED, armsInterventionsModule interventions name: Non-immunogenic recombinant staphylokinase, interventions name: Placebo, outcomesModule primaryOutcomes measure: Composite of death from any cause or hemodynamic collapse or recurrent PE, secondaryOutcomes measure: Right/left ventricular (RV/LV) end-diastolic diameter ratio, secondaryOutcomes measure: RV/LV end-diastolic diameter ratio, secondaryOutcomes measure: RV/LV end-diastolic diameter ratio, secondaryOutcomes measure: Right ventricular (RV) end-diastolic volume, secondaryOutcomes measure: Qanadli index, secondaryOutcomes measure: Systolic pulmonary artery pressure, secondaryOutcomes measure: In hospital death from all causes (assessed up to day 7), secondaryOutcomes measure: Death from all causes, secondaryOutcomes measure: Safety endpoint - hemorrhagic stroke, secondaryOutcomes measure: Safety endpoint - BARC type 3 and 5 bleeding, secondaryOutcomes measure: Safety endpoint - number and severity of adverse events (AEs) and serious AEs in organs and systems, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: V.F. Dolgopolov Vyselki Central District Hospital, city: Vyselki, state: Krasnodar Region, zip: 353100, country: Russian Federation, contacts name: Valerii V. Makukhin, PhD, role: CONTACT, phone: (86199) 123-53, phoneExt: +7, email: makuhinv@mail.ru, contacts name: Valerii V. Makukhin, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 45.58128, lon: 39.66409, locations facility: I.P. Pavlov Ryazan State Medical University, city: Ryazan', state: Ryazan, zip: 390026, country: Russian Federation, contacts name: Denis S. Yunevich, PhD, role: CONTACT, phone: (4912) 46-63-90, phoneExt: +7, email: yunevichden@ya.ru, contacts name: Denis S. Yunevich, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 54.6269, lon: 39.6916, locations facility: Belgorod Regional Clinical Hospital of St. Joseph, city: Belgorod, zip: 308007, country: Russian Federation, contacts name: Sergei L Konstantinov, MD, role: CONTACT, email: konstantinov5@yandex.ru, contacts name: Sergei L Konstantinov, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 50.61074, lon: 36.58015, locations facility: Kuzbass Cardiology center, city: Kemerovo, zip: 650002, country: Russian Federation, contacts name: Vasilii V. Kashtalap, MD, PhD, role: CONTACT, phone: +7 (3842) 64-22-41, email: v_kash@mail.ru, contacts name: Vasilii V. Kashtalap, MD, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 55.33333, lon: 86.08333, locations facility: City Clinical Hospital №1, city: Kirov, zip: 610035, country: Russian Federation, contacts name: Oleg V. Solovyev, PhD, role: CONTACT, phone: (8332) 56-35-74, phoneExt: +7, email: ckn@medkirov.ru, contacts name: Oleg V. Solovyev, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 58.59665, lon: 49.66007, locations facility: Regional Clinical Hospital №2, city: Krasnodar, zip: 350012, country: Russian Federation, contacts name: Tamara A. Chirva, MD, role: CONTACT, phone: (861) 222-000-2, phoneExt: +7, email: makuhinv@mail.ru, contacts name: Tamara A. Chirva, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 45.04484, lon: 38.97603, locations facility: S.S. Yudin City Clinical Hospital, city: Moscow, zip: 115446, country: Russian Federation, contacts name: Bogdan B Orlov, MD, PhD, role: CONTACT, phone: 7 (499) 612-45-66, email: bborlov@mail.ru, contacts name: Bogdan B Orlov, MD, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 55.75222, lon: 37.61556, locations facility: V.V. Vinogradov City Clinical Hospital, city: Moscow, zip: 117292, country: Russian Federation, contacts name: Imad Merai, MD, PhD, role: CONTACT, phone: +7 (495) 103 46 66, email: imadmerai@yahoo.com, contacts name: Imad Merai, MD, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 55.75222, lon: 37.61556, locations facility: S.P. Botkin City Clinical Hospital, city: Moscow, country: Russian Federation, contacts name: Yuri V. Karabach, PhD, role: CONTACT, phone: (499) 490-03-03, phoneExt: +7, email: yu.karabach@ya.ru, contacts name: Yuri V. Karabach, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 55.75222, lon: 37.61556, locations facility: N.N. Burdenko Penza Regional Clinical hospital, city: Penza, zip: 440026, country: Russian Federation, contacts name: Valentin E. Oleynikov, MD, PhD, role: CONTACT, phone: +7 (8412) 54-84-07, email: oleynikof@gmail.com, contacts name: Valentin E. Oleynikov, MD, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 53.20066, lon: 45.00464, locations facility: G.A. Zakharyin Clinical hospital №6, city: Penza, zip: 440071, country: Russian Federation, contacts name: Elena S. Panina, PhD, role: CONTACT, phone: (8412) 98-33-55, phoneExt: +7, email: panina.es@mail.ru, contacts name: Elena S. panina, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 53.20066, lon: 45.00464, locations facility: City Clinical Hospital №4, city: Perm, zip: 614107, country: Russian Federation, contacts name: Oleg M. Lapin, PhD, role: CONTACT, phone: 342-263-01-06, phoneExt: +7, email: heparin@yandex.ru, contacts name: Oleg M. Lapin, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 58.01046, lon: 56.25017, locations facility: V.P. Polyakov Samara Regional Clinical Cardiology Dispensary, city: Samara, zip: 443070, country: Russian Federation, contacts name: Dmitrii V Duplyakov, MD, PhD, role: CONTACT, phone: 8 (846) 373-70-63, email: duplyakov@yahoo.com, contacts name: Dmitrii V Duplyakov, MD, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 53.20007, lon: 50.15, hasResults: False