Phase 3
N=310
Massive Pulmonary Embolism: Trial of Non-immunogenic Recombinant Staphylokinase VS Alteplase FORPE
Massive Pulmonary Embolism
Bottom Line
View on ClinicalTrials.gov: NCT04688320 ↗Enrolled (actual)
310
Serious AEs
8.9%
Results posted
Apr 2025
Primary outcome: Primary: Death From All Causes — 3; 4 Participants — p=<0.05
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Recombinant nonimmunogenic staphylokinase (Drug); Alteplase (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Supergene, LLC
- Primary completion
- Jul 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Death From All Causes |
6; 4 | — |
| SECONDARY Systolic Pulmonary Artery Pressure Measures (V1, V2, V4, V5) |
59; 58; 44; 42; 36; 35 | — |
| SECONDARY Haemodynamic Collapse |
1; 3 | — |
| SECONDARY Recurrent Pulmonary Embolism (PE) |
1; 2 | — |
| SECONDARY Death From PE |
4; 2 | — |
| SECONDARY Death From All Causes |
6; 4 | — |
| SECONDARY Haemodynamic Collapse Within 7 Days + Recurrent PE Within 7 Days + Death From All Causes Within 30 Days |
8; 9 | — |
| SECONDARY Safety Endpoint - Haemorrhagic Stroke |
0; 3 | — |
| SECONDARY Safety Endpoint - BARC Type 3+5 Bleeding |
0; 5 | — |
| SECONDARY Safety Endpoint - Number and Severity of Serious Adverse Events (SAEs) |
9; 17 | — |
Summary
Objective: to evaluate the efficacy and safety of the Recombinant Non-immunogenic Staphylokinase with its single bolus administration in comparison with the bolus-infusion administration of the Alteplase in patients with massive pulmonary embolism
Eligibility Criteria
Inclusion Criteria
- Men and women aged 18 and over
- Verified diagnosis of massive PE (using MSCT with PA contrast)
- Signs of overload / dysfunction of the right ventricle (at least one) in combination with persistent arterial hypotension or shock
- 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, hemorrhagic diathesis;
- Intracranial (including subarachnoid) hemorrhage at present or in history, suspected hemorrhagic stroke;
- A history of hemorrhagic stroke or stroke of unknown etiology;
- Ischemic stroke or transient ischemic attack within the last 6 months, except for the current acute ischemic stroke within 4.5 hours;
- A history of diseases of the central nervous system (including neoplasms, aneurysms, surgery on the brain or spinal cord);
- Major surgery or major trauma within the previous 3 months, recent traumatic brain injury;
- Long-term or traumatic cardiopulmonary resuscitation (> 2 min), delivery within the previous 10 days, recent puncture of an uncompressible 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 three months;
- Neoplasm with an increased risk of bleeding;
- Concurrent administration of oral anticoagulants, for example, warfarin with an INR> 1.3;
- Arterial aneurysms, developmental defects of arteries / veins;
- Severe uncontrolled arterial hypertension;
- Acute pancreatitis;
- Bacterial endocarditis, pericarditis;
- suspicion of aortic dissecting aneurysm;
- any other conditions, in the opinion of the doctor, associated with a high risk of bleeding.
- Lactation, pregnancy
- Known hypersensitivity to Alteplase, Fortelizin.
Data sourced from ClinicalTrials.gov (NCT04688320). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.