Non-immunogenic staphylokinase (Fortelyzin®) for massive pulmonary embolism

An Open, Prospective, Non-interventional, Multicentre, Controlled Study of Safety and Efficacy of the Thrombolysis With the Non-immunogenic Staphylokinase in Patients With Massive Pulmonary Embolism (FORPE Registry)

This project tests whether a single 15 mg bolus of non-immunogenic staphylokinase (Fortelyzin®) is safe and works for adults with massive pulmonary embolism.

Quick facts

• Study type: Observational
• Enrollment: 20000 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Supergene, LLC (industry)
• Drugs / interventions: idarucizumab
• Locations: 1 site (Moscow)
• Trial ID: NCT07245927 on ClinicalTrials.gov

What this trial studies

The FORPE Registry is a post‑registration, observational registry collecting routine clinical data on adults treated with a single 15 mg intravenous bolus of non‑immunogenic staphylokinase for CT‑confirmed massive pulmonary embolism. Eligible patients have signs of right ventricular overload or dysfunction combined with persistent arterial hypotension or shock and symptom onset within 14 days. The registry tracks safety outcomes (including major bleeding and intracranial hemorrhage) and clinical efficacy in real‑world emergency settings. The registry follows publication of a prior multicenter randomized non‑inferiority trial that reported non‑inferiority to alteplase with fewer major bleedings.

Who should consider this trial

Good fit: Adults (age ≥18) with CT‑confirmed massive pulmonary embolism, evidence of right ventricular dysfunction plus persistent hypotension or shock, symptom onset within 14 days, and no contraindications to thrombolysis are the intended participants.

Not a fit: Patients with high bleeding risk (recent major surgery or trauma, recent intracranial hemorrhage or CNS disease, recent incompressible vessel puncture), those without massive PE, and pediatric patients are unlikely to benefit from this treatment.

Why it matters

Potential benefit: If successful, this treatment could offer a rapid, weight‑independent, single‑dose thrombolytic option with potentially lower risk of major bleeding for patients with massive pulmonary embolism.

How similar studies have performed: A prior multicenter randomized non‑inferiority trial (FORPE, NCT04688320) reported that non‑immunogenic staphylokinase was non‑inferior to alteplase and had fewer major bleedings, providing supportive evidence for this approach.

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.

Where this trial is running

Moscow

• E.I. Chazov National Medical Research Center of Cardiology — Moscow, Russia (RECRUITING)

Study contacts

• Study coordinator: Sergei S. Markin, MD, Prof.

Conditions: Pulmonary Embolism Acute Massive, Pulmonary Embolism