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

Launched by SUPERGENE, LLC · Apr 8, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called non-immunogenic recombinant staphylokinase for patients with a condition known as pulmonary embolism (PE), which occurs when a blood clot blocks blood vessels in the lungs. The goal is to find out if this treatment is effective and safe compared to a placebo (a treatment that does not contain active medication) in patients who are at intermediate risk for serious complications from PE. The trial is currently recruiting participants aged 18 and older, who have recently been diagnosed with PE and show signs of heart strain, but who are not in immediate danger of collapsing or experiencing severe bleeding.

To participate, individuals must meet specific criteria, such as having a confirmed diagnosis of intermediate high-risk PE and certain heart-related symptoms. Participants will receive either the new treatment or a placebo and will be monitored closely throughout the study. It's important for potential participants to know that there are some exclusions, such as those with severe bleeding risks or those who are pregnant or breastfeeding. By joining this trial, participants will contribute to research that could improve treatment options for future patients with pulmonary embolism.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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:
• • 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:
• • 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 mon-immunogenic recombinant staphylokinase.