NCT07245927 Post-registration Trial of the Non-immunogenic Staphylokinase in Massive Pulmonary Embolism
| NCT ID | NCT07245927 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Supergene, LLC |
| Condition | Pulmonary Embolism Acute Massive |
| Study Type | OBSERVATIONAL |
| Enrollment | 20,000 participants |
| Start Date | 2025-06-01 |
| Primary Completion | 2027-10-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 20,000 participants in total. It began in 2025-06-01 with a primary completion date of 2027-10-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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 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.
Contact & Investigator
Sergey N. Tereschenko, MD, Prof.
PRINCIPAL INVESTIGATOR
E.I. Chazov National Medical Research Center of Cardiology
Frequently Asked Questions
Who can join the NCT07245927 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Pulmonary Embolism Acute Massive. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07245927 currently recruiting?
Yes, NCT07245927 is actively recruiting participants. Contact the research team at stereschenko@yandex.ru for enrollment information.
Where is the NCT07245927 trial being conducted?
This trial is being conducted at Belgorod, Russia, Kemerovo, Russia, Kirov, Russia, Lipetsk, Russia and 10 additional locations.
Who is sponsoring the NCT07245927 clinical trial?
NCT07245927 is sponsored by Supergene, LLC. The principal investigator is Sergey N. Tereschenko, MD, Prof. at E.I. Chazov National Medical Research Center of Cardiology. The trial plans to enroll 20,000 participants.