Post-registration Trial of the Non-immunogenic Staphylokinase in Massive Pulmonary Embolism (NCT07245927) | Clinical Trial Compass
RecruitingNot Applicable
Post-registration Trial of the Non-immunogenic Staphylokinase in Massive Pulmonary Embolism
Russia20,000 participantsStarted 2025-06-01
Plain-language summary
The aim of FORPE Registry is to study the safety and efficacy of the non-immunogenic staphylokinase in patients with massive pulmonary embolism in routine clinical practice.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Men and women aged 18 years and older.
* Verified diagnosis of massive pulmonary embolism (using computer tomography)
* Signs of overload / dysfunction of the right ventricle (at least one) in combination with persistent arterial hypotension or shock
* The time from the symptoms onset is no more than 14 days.
* Thrombolysis with the non-immunogenic staphylokinase, 15 mg as a single intravenous bolus.
Exclusion Criteria:
* 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 dissectin…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.