Status:
COMPLETED
Efficacy and Safety Study of Proposed Biosimilar Product Reveliza vs Actilise in Patients With ST-segment Elevation Myocardial Infarction
Lead Sponsor:
AO GENERIUM
Conditions:
Myocardial Infarction (MI)
Eligibility:
All Genders
18-80 years
Phase:
PHASE3
Brief Summary
Thi is is a multi-center, randomized, single-blind, parallel group clinical trial to evaluate the efficacy and safety of the intravenious thrombolysis with Revelise® (GENERIUM, Russia) in comparosin w...
Detailed Description
Revelise®, lyophilizate for solution for infusion, 50 mg, is the proposed biosimilar recombinant human tissue plasminogen activator developed by GENERIUM JSC (Russia). All the patients with acute myo...
Eligibility Criteria
Inclusion
- Age between 18 and 80 years
- Acute myocardial infarction with ST-segment elevation on ECG (point J) in 2 or more consecutive leads of more than 0.2 mV in men or more than 0.15 mV in women in leads V2-V3 or more than 0.1 mV in other leads after not more than 12 hours from pain onset (lasting at least 20 minutes) in chest (at the time of screening).
- Written informed consent of the patient for participation in the trial and conduction of coronary angiography.
Exclusion
- 1\. Significant bleeding at present or during the previous 6 months, hemorrhagic diathesis.
- 4\. Congenital-hereditary hemorrhagic coagulopathy (hemophilia, etc.) in medical history 5. Concomitant administration of oral anticoagulants, for example, warfarin (INR \> 1.3).
- 6\. Surgery of the brain or spinal cord, neoplasms of the brain or spinal cord in past medical history, traumatic brain injury during the last 3 months.
- 7\. Intracranial (including subarachnoid) hemorrhage currently or in past medical history.
- 8\. Hemorrhagic stroke or stroke of unknown etiology in the anamnesis, suspected hemorrhagic stroke.
- 9\. Ischemic stroke or transient ischemic attack during the last 6 months. 10. Severe (systolic blood pressure higher than 185 mmHg or diastolic blood pressure higher than 110 mmHg) uncontrolled hypertension.
- 11\. Extensive surgery or significant trauma during the previous 3 weeks (including any injury combined with this acute myocardial infarction).
- 12\. Long-term or traumatic cardiopulmonary resuscitation (\>2 min), delivery during the previous 10 days; recently performed puncture of an incompressible blood vessel (for example, subclavian or jugular vein).
- 13\. Bacterial endocarditis, pericarditis. 14. Known arterial aneurysms, defects in arteries or veins' development, suspected aortic dissection.
- 15\. Confirmed gastric ulcer or duodenal ulcer during the last 3 months. 16. Known severe liver diseases, including liver failure, cirrhosis, portal hypertension (including esophageal varicose veins dilatation), active hepatitis.
- 17\. Acute pancreatitis. 18. Known neoplasm with an increased risk of bleeding. 19. Hypersensitivity to the components of the product, allergic reactions to gentamicin in past medical history.
- 20\. Pregnancy or lactation.
Key Trial Info
Start Date :
May 25 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 11 2017
Estimated Enrollment :
180 Patients enrolled
Trial Details
Trial ID
NCT07146360
Start Date
May 25 2014
End Date
December 11 2017
Last Update
August 28 2025
Active Locations (22)
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1
Regional State Budgetary Healthcare Institution "Altai Regional Cardiological Dispensary"
Barnaul, Altayskiy Kray, Russia, 656055
2
City Budgetary Healthcare Institution of Arkhangelsk Region "First City Clinical Hospital named after E.E. Volosevich"
Arkhangelsk, Arkhangelskaya oblast, Russia, 163001
3
SBHI Republican Cardiology Center
Ufa, Bashkortostan Republic, Russia, 450106
4
State Budgetary Healthcare Institution of Novosibirsk "City Clinical Hospital No. 2"
Novosibirsk, Novosibirsk Oblast, Russia, 630051