Comparing a new treatment for pulmonary embolism to a placebo

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

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.

Why it matters

Who can join: the full rules

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 it's running

• RZD Medicine hospital
  Barnaul, Altayskiy Kray, Russia Recruiting
• V.F. Dolgopolov Vyselki Central District Hospital
  Vyselki, Krasnodarskiy Kray, Russia Recruiting
• Belgorod Regional Clinical Hospital of St. Joseph
  Belgorod, Russia Recruiting
• Kuzbass Cardiology center
  Kemerovo, Russia Recruiting
• Center of Neurology and Cardiology
  Kirov, Russia Recruiting
• Regional Clinical Hospital №2
  Krasnodar, Russia Recruiting

Study contacts

• Principal investigator: Sergey N. Tereschenko, MD, PhD — National Medical Research Center for Cardiology, Ministry of Health of Russian Federation
• Study coordinator: Sergey S. Markin, MD, PhD
• Email: ssmarkin2153@mail.ru
• Phone: (906) 796-89-06

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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.