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Compares treatment options for Pulmonary Embolism
Official title Non-immunogenic Recombinant Staphylokinase vs Placebo in Patients With Intermediate High-risk Pulmonary Embolism
ClinicalTrials.gov ID: NCT06362746
What this study is testing
What is Non-immunogenic recombinant staphylokinase?
Non-immunogenic recombinant staphylokinase is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for pulmonary embolism.
Also referred to as Fortelyzin®.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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)
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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;
You likely can't join if
- 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);
See the full eligibility 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:
- 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...
- 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Barnaul, Altayskiy Kray, Russia
- Vyselki, Krasnodarskiy Kray, Russia
- Asino, Tomsk Oblast, Russia
- Belgorod, Russia
- Kemerovo, Russia
- Kirov, Russia
- Krasnodar, Russia
- Lipetsk, Russia
- Moscow, Russia
- Nizhny Novgorod, Russia
- Penza, Russia
- Perm, Russia
- Saint Petersburg, Russia
- Samara, Russia
- Tomsk, Russia
- Tver', Russia
- Ufa, Russia
- Volgograd, Russia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Barnaul, Altayskiy Kray, Russia; Vyselki, Krasnodarskiy Kray, Russia; Asino, Tomsk Oblast, Russia; Belgorod, Russia; Kemerovo, Russia; Kirov, Russia and 12 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.