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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Belgorod Regional Clinical Hospital of St. Joseph
  Belgorod, Russia Recruiting
• Kuzbass Cardiology center
  Kemerovo, Russia Recruiting
• Center of Neurology and Cardiology
  Kirov, Russia Recruiting
• Lipetsk City Hospital No. 4 "Lipetsk-Med"
  Lipetsk, Russia Recruiting
• E.I. Chazov National Medical Research Center of Cardiology
  Moscow, Russia Recruiting
• F.I. Inozemtsev City Clinical Hospital
  Moscow, Russia Recruiting

Study contacts

• Principal investigator: Sergey N. Tereschenko, MD, Prof. — E.I. Chazov National Medical Research Center of Cardiology
• Study coordinator: Sergey N. Tereschenko, MD, Prof.
• Email: stereschenko@yandex.ru
• Phone: 495-150-44-19

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.