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Comparing a new treatment for pulmonary embolism to a placebo

Multicenter, Double-blind, Randomized, Placebo-controlled Trial of the Efficacy and Safety of a Single Bolus Administration of Non-immunogenic Recombinant Staphylokinase in Patients With Intermediate High-risk Pulmonary Embolism (FORPE-2)

PHASE3 · Supergene, LLC · NCT06362746

This study is testing a new treatment for pulmonary embolism to see if it helps patients feel better without causing serious bleeding, compared to a placebo.

Quick facts

PhasePHASE3
Study typeInterventional
Enrollment486 (estimated)
Ages18 Years and up
SexAll
SponsorSupergene, LLC (industry)
Drugs / interventionsidarucizumab
Locations24 sites (Barnaul, Altayskiy Kray and 23 other locations)
Trial IDNCT06362746 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the efficacy and safety of non-immunogenic recombinant staphylokinase administered as a single bolus in patients with intermediate high-risk pulmonary embolism compared to a placebo. The study focuses on normotensive patients who have been diagnosed with pulmonary embolism and exhibit right ventricular dysfunction. The aim is to determine if this new thrombolytic agent can improve clinical outcomes without the high risk of hemorrhagic complications associated with previous treatments. Participants will be monitored for improvements in pulmonary obstruction and right ventricle function.

Who should consider this trial

Good fit: Ideal candidates are men and women aged 18 and over with a verified diagnosis of intermediate high-risk pulmonary embolism and specific clinical indicators of risk.

Not a fit: Patients who do not have intermediate high-risk pulmonary embolism or those with contraindications to thrombolytic therapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a safer thrombolytic option for patients with intermediate high-risk pulmonary embolism.

How similar studies have performed: Previous studies have shown success with similar thrombolytic approaches, but this specific agent is being tested for the first time in this patient population.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion 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:

  1. systolic blood pressure less than 110 mm Hg, but not less than 90 mm Hg for more than 15 minutes;
  2. respiratory rate more than 20 per minute or SpO2 less than 90% without oxygen support;
  3. 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. Women who are not fertile can also take part in the study (documented conditions: hysterectomy, tubal ligation, infertility, menopause for more than 1 year);
  * 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.

Exclusion Criteria:

* 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.

Where this trial is running

Barnaul, Altayskiy Kray and 23 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Pulmonary Embolism, Intermediate high-risk pulmonary embolism, Fibrinolysis, Recombinant Non-immunogenic Staphylokinase

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.