Status:
COMPLETED
Massive Pulmonary Embolism: Trial of Non-immunogenic Recombinant Staphylokinase VS Alteplase FORPE
Lead Sponsor:
Supergene, LLC
Conditions:
Massive Pulmonary Embolism
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Objective: to evaluate the efficacy and safety of the Recombinant Non-immunogenic Staphylokinase with its single bolus administration in comparison with the bolus-infusion administration of the Altepl...
Detailed Description
The main goal of treating massive PE is to save the lives of patients by restoring pulmonary perfusion, preventing the development of chronic postembolic pulmonary hypertension and recurrent PE. Accor...
Eligibility Criteria
Inclusion
- Men and women aged 18 and over
- Verified diagnosis of massive PE (using MSCT with PA contrast)
- Signs of overload / dysfunction of the right ventricle (at least one) in combination with persistent arterial hypotension or shock
- 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
- • Increased risk of bleeding:
- Extensive bleeding at present or within the previous 6 months, hemorrhagic diathesis;
- Intracranial (including subarachnoid) hemorrhage at present or in history, suspected hemorrhagic stroke;
- A history of hemorrhagic stroke or stroke of unknown etiology;
- Ischemic stroke or transient ischemic attack within the last 6 months, except for the current acute ischemic stroke within 4.5 hours;
- A history of diseases of the central nervous system (including neoplasms, aneurysms, surgery on the brain or spinal cord);
- Major surgery or major trauma within the previous 3 months, recent traumatic brain injury;
- Long-term or traumatic cardiopulmonary resuscitation (\> 2 min), delivery within the previous 10 days, recent puncture of an uncompressible 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 three months;
- Neoplasm with an increased risk of bleeding;
- Concurrent administration of oral anticoagulants, for example, warfarin with an INR\> 1.3;
- Arterial aneurysms, developmental defects of arteries / veins;
- Severe uncontrolled arterial hypertension;
- Acute pancreatitis;
- Bacterial endocarditis, pericarditis;
- suspicion of aortic dissecting aneurysm;
- any other conditions, in the opinion of the doctor, associated with a high risk of bleeding.
- Lactation, pregnancy
- Known hypersensitivity to Alteplase, Fortelizin.
Key Trial Info
Start Date :
December 15 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 27 2023
Estimated Enrollment :
310 Patients enrolled
Trial Details
Trial ID
NCT04688320
Start Date
December 15 2020
End Date
July 27 2023
Last Update
April 2 2025
Active Locations (23)
Enter a location and click search to find clinical trials sorted by distance.
1
V.F. Dolgopolov Vyselki Central District Hospital
Vyselki, Krasnodarskiy Kray, Russia, 353100
2
Sergiyev Posad Regional Clinical Hospital
Sergiyev Posad, Moscow Oblast, Russia, 141301
3
Belgorod Regional Clinical Hospital of St. Joseph
Belgorod, Russia, 308007
4
Kuzbass Cardiology center
Kemerovo, Russia, 650002