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
This trial does not accept healthy volunteersQualifiers
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 population
Men and women aged 18 years and older with verified massive pulmonary embolism, who received a single intravenous bolus of the non-immunogenic staphylokinase (15 mg).
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Non-immunogenic staphylokinasenon-immunogenic staphylokinase 15 mg as a single intravenous bolus Other Names: Fortelyzin®
DrugNon-immunogenic staphylokinase 15 mg as a single intravenous bolus
Treatment groups
20,000 Participants
are divided into 1 treatment groupGroup A: Non-immunogenic staphylokinase1 intervention
Trial outcomes
Primary outcomes
1
All-cause mortality
The number of death from any causes during hospitalization
Time frame
day 7 after drug administrationSecondary outcomes
1
All-cause mortality
The number of death from any causes during 30 days after drug administration
Time frame
day 30 after drug administration2
Haemodynamic Collapse
The number of haemodynamic collapses from any causes during 30 days after drug administration
Time frame
day 30 after drug administration3
Recurrent Pulmonary Embolism
The number of recurrent pulmonary embolism from any causes during 30 days after drug administration
Time frame
day 30 after drug administration4
Pulmonary Artery Systolic Pressure Measures
The efficacy is evaluated in terms of pulmonary artery systolic pressure after drug administration
Time frame
baseline and day 2 after drug administrationOther outcomes
1
Intracranial haemorrhage
The number of intracranial haemorrhage during 30 days after drug administration
Time frame
day 30 after drug administration2
Major bleedings
The number of major bleedings (according to BARC classification type 3 and 5) during 30 days after drug administration
Time frame
day 30 after drug administrationSponsors and contacts
Click on the lead sponsor to view all of their trials.
Supergene, LLC
Lead sponsor
National Medical Research Center for Cardiology, Ministry of Health of Russian Federation
Collaborator
Source ClinicalTrials.gov