Non-immunogenic Recombinant Staphylokinase vs Placebo in Patients With Intermediate High-risk Pulmonary Embolism
Multicenter, Double-blind, Randomized, Placebo-controlled Trial of the Efficacy and Safety of a Single Bolus Administration of Non-immunogenic Recombinant Staphylokinase in Patients With Intermediate High-risk Pulmonary Embolism (FORPE-2)
Supergene, LLC
486 participants
May 23, 2024
INTERVENTIONAL
Conditions
Summary
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)
Eligibility
Inclusion Criteria12
- 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:
- systolic blood pressure less than 110 mm Hg, but not less than 90 mm Hg for more than 15 minutes;
- respiratory rate more than 20 per minute or SpO2 less than 90% without oxygen support;
- 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 Criteria20
- 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 the non-immunogenic recombinant staphylokinase.
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Interventions
15 mg of drug reconstituted in 15 ml of 0.9% solution of NaCl given as single i.v. bolus over 10-15 seconds
15 mg of placebo reconstituted in 15 ml of 0.9% solution of NaCl given as single i.v. bolus over 10-15 seconds
Locations(24)
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NCT06362746