Recombinant Non-immunogenic Staphylokinase VS Alteplase for Massive PE a Randomized Non-inferiority Trial

• Status: Recruiting
• Trial end date: 2021-12-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Supergene, LLC
• Treatments: Tissue Plasminogen Activator

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.