Actively Recruiting
Post-registration Trial of the Non-immunogenic Staphylokinase in Massive Pulmonary Embolism
Led by Supergene, LLC · Updated on 2025-11-24
20000
Participants Needed
1
Research Sites
134 weeks
Total Duration
On this page
Sponsors
S
Supergene, LLC
Lead Sponsor
N
National Medical Research Center for Cardiology, Ministry of Health of Russian Federation
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Post-registration Trial of the Non-immunogenic Staphylokinase in Massive Pulmonary Embolism
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Men and women aged 18 years and older
- Verified diagnosis of massive pulmonary embolism using computer tomography
- Signs of overload or dysfunction of the right ventricle combined with persistent low blood pressure or shock
- Symptom onset no more than 14 days prior
- Treatment with a single intravenous bolus of 15 mg non-immunogenic staphylokinase
You will not qualify if you...
- Increased risk of bleeding including extensive bleeding within past 6 months
- Intracranial or subarachnoid hemorrhage currently or in history
- Hemorrhagic stroke within last 6 months
- History of central nervous system diseases including tumors or aneurysms
- Intracranial or spinal surgery within last 2 months
- Major surgery or trauma within previous 4 weeks
- Recent puncture of incompressible blood vessels
- Severe liver disease such as liver failure, cirrhosis, portal hypertension, or active hepatitis
- Gastric or duodenal ulcer within last 3 months
- Neoplasm with increased bleeding risk
- Taking Dabigatran without prior idarucizumab
- Arterial aneurysms or developmental artery/vein defects
- Acute pancreatitis
- Bacterial endocarditis or pericarditis
- Suspected aortic dissecting aneurysm
- Any other condition deemed high bleeding risk by investigator
- Pregnancy or breastfeeding
- Known allergy to non-immunogenic recombinant staphylokinase
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
E.I. Chazov National Medical Research Center of Cardiology
Moscow, Russia, 121552
Actively Recruiting
Research Team
S
Sergei S. Markin, MD, Prof.
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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