Post-registration Trial of the Non-immunogenic Staphylokinase in Massive Pulmonary Embolism
ConditionPulmonary Embolism Acute Massive
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorSupergene, LLC
About this trial
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
Qualifiers
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.
Disqualifiers
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);
Trial design
Treatments tested in this trial
- Non-immunogenic staphylokinasenon-immunogenic staphylokinase 15 mg as a single intravenous bolus Other Names: Fortelyzin®
Treatment groups
20,000 Participants
are divided into 1 treatment groupSponsors and collaborators
Supergene, LLC
Lead sponsor
National Medical Research Center for Cardiology, Ministry of Health of Russian Federation
Collaborator
Source ClinicalTrials.gov