Myocardial Infarction (MI)Phase 3NCT07146360
Efficacy and Safety Study of Proposed Biosimilar Product Reveliza vs Actilise in Patients With ST-segment Elevation Myocardial Infarction
A Phase 3 study testing Revelise (GENERIUM, Russia) and Actilyse® (Boehringer Ingelheim Pharma GmbH and Co.KG, Germany) in people with Myocardial Infarction (MI), run by AO GENERIUM at 22 sites in Russia.
Trial 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 with the Actilyse® (Boehringer Ingelheim Pharma GmbH and Co.KG, Germany) in patients with acute myocardial infarction… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Myocardial Infarction (MI)
- What is being tested?
- Revelise (GENERIUM, Russia) and Actilyse® (Boehringer Ingelheim Pharma GmbH and Co.KG, Germany)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 22 sitesRussia
- Study dates
- 25 May 2014to 11 Dec 2017
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 12Show fewer
- 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.
Trial locations and contacts
22 sites in 1 country.
22 sites in 1 country
Russia22 sites
City Budgetary Healthcare Institution of Arkhangelsk Region "First City Clinical Hospital named after E.E. Volosevich"
Arkhangelsk, Arkhangelskaya oblast, 163001
Regional State Budgetary Healthcare Institution "Altai Regional Cardiological Dispensary"
Barnaul, Altayskiy Kray, 656055
Federal State Budgetary Scientific Institution "Scientific Research Institute for Complex Issues of Cardiovascular Diseases"
Kemerovo, 650002
SBHI "State Budgetary Healthcare Institution of MHD"
Moscow, 101000
Moscow City State Budgetary Healthcare Institution "Filatov City Clinical Hospital No. 15 of Moscow Healthcare Department"
Moscow, 111539
State Budgetary Healthcare Institution of the city of Moscow "City Clinical Hospital No. 64 of Moscow Healthcare Department"
Moscow, 117292
Federally Funded Higher Education Institution "Russian National Research Medical University named after N.I. Pirogov" of the Ministry of Health of the Russian Federation
Moscow, 117997
Moscow City State Budgetary Healthcare Institution "Botkin City Clinical Hospital of Moscow Healthcare Department"
Moscow, 125284
SBHI "CCH No. 81 MHD"
Moscow, 127644
SBHI "Sklifosovsky Research Institute of Emergency Medicine of MHD"
Moscow, 129090
State Budgetary Healthcare Institution of Novosibirsk "City Clinical Hospital No. 2"
Novosibirsk, Novosibirsk Oblast, 630051
Novosibirsk Region State Budgetary Healthcare Institution "City Clinical Hospital No. 1"
Novosibirsk, 630047
Novosibirsk Region State Budgetary Healthcare Institution "City Clinical Hospital No. 34"
Novosibirsk, 630054
Municipal Health Care Institution City Clinical Hospital No.4
Perm, Perm Krai, 614107
Municipal Budgetary Healthcare Institution "City Emergency Medical Hospital of Rostov-on-Don"
Rostov-on-Don, 344068
SI "St. Petersburg Dzhanelidze Research Institute of Emergency Medicine"
Saint Petersburg, 192242
St. Petersburg State Budgetary Healthcare Institution "Pokrovskaya City Hospital"
Saint Petersburg, 199106
FSBEI of HVE Mordovia State University named after N.P. Ogarev, Medical Institute, SBHI MR "City Clinical Hospital No. 3"
Saransk, Respublika Mordoviya, 430005
FSI Saratov Research Institute of Cardiology of Russian medical Technologies
Saratov, 410028
State Healthcare Institution "City Clinical Hospital No. 12"
Saratov, 410039
SBHI SC "Stavropol Regional Clinical Hospital"
Stavropol, 355000
SBHI Republican Cardiology Center
Ufa, Bashkortostan Republic, 450106
About this study
Official title: A Multi-center, Randomized, Single-blind, Parallel Group Clinical Trial to Evaluate the Efficacy and Safety of the Revelise® (GENERIUM, Russia) as Compared With the Actilyse® (Boehringer Ingelheim Pharma GmbH and Co.KG, Germany) in Patients With Acute Myocardial Infarction With ST-segment Elevation on ECG
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 with the Actilyse® (Boehringer Ingelheim Pharma GmbH and Co.KG, Germany) in patients with acute myocardial infarction (MI) with ST-segment elevation on the electrocardiogram (ECG). The thrombolisis was performed within the period of up to 6 hours and from 6 to 12 hours from the MI symptoms onset.
Read the 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 myocardial infurction, enrolled into the study, have been randomised to receive either biosimilar product or a reference produc. The stratification factor was the time from the MI symptoms onset: 1) within the 6 hours and 2) from 6 to 12 hours. Each patient was then followed-up for 3 months, including up to 14 days in an inpatient facility. Coronary angiography was to be performed within the first 24 hours after the administration of the study products, but not earlier than 3 hours after beginning of infusion in case of confirmed thrombolysis (onset of myocardial reperfusion) and immediately - in the absence of reperfusion according to ECG data (ST-segment reduction by less than 50% afterthe infusion start). The patients' condition will be assessed at the scheduled visits.
- Conditions
- Myocardial Infarction (MI)
- Being tested
- Revelise (GENERIUM, Russia), Actilyse® (Boehringer Ingelheim Pharma GmbH and Co.KG, Germany)
- Keywords
- Acute Myocardial Infarction, Thrombosis, Recombinant tissue plasminogen activator, Acute Coronary Syndrome, Coronary Syndrome, Chronic heart failure, Activated partial thromboplastin time, New York Heart Association, Thrombolytic therapy
- Medical subject headings
- Myocardial Infarction, Thrombosis, Acute Coronary Syndrome, Angina, Unstable
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Revelise (GENERIUM, Russia)Biological
- 90-minute accelerated dosing regimen for patients who can start treatment within 6 hours after the onset of symptoms of acute myocardial infarction (AMI): Initial bolus injection: 15 mg intraveniously (IV) followed by an infusion of 50 mg over 30 minutes and then a subsequent infusion of 35 mg over 60 minutes to reach a maximum total dose of 100 mg.
- For patients less than 65 kg: Initial bolus injection: 15 mg IV - 0.75 mg/kg (maximum 50 mg) over 30 minutes followed by an additional infusion of 0.5 mg/kg (maximum 35 mg) over 60 minutes.
- 3-hour dosing regimen for patients who can start treatment between 6 and 12 hours after symptom onset of AMI: Initial bolus injection: 10 mg IV followed by an infusion of 50 mg over 60 minutes and then a subsequent infusion of 40 mg over 120 minutes to achieve a maximum total dose of 100 mg.
- For patients less than 65 kg: The cumulative dose should not exceed 1.5 mg/kg.
Actilyse® (Boehringer Ingelheim Pharma GmbH and Co.KG, Germany)Biological
- 90-minute accelerated dosing regimen for patients who can start treatment within 6 hours after the onset of symptoms of acute myocardial infarction (AMI): Initial bolus injection: 15 mg intraveniously (IV) followed by an infusion of 50 mg over 30 minutes and then a subsequent infusion of 35 mg over 60 minutes to reach a maximum total dose of 100 mg.
- For patients less than 65 kg: Initial bolus injection: 15 mg IV - 0.75 mg/kg (maximum 50 mg) over 30 minutes followed by an additional infusion of 0.5 mg/kg (maximum 35 mg) over 60 minutes.
- 3-hour dosing regimen for patients who can start treatment between 6 and 12 hours after symptom onset of AMI: Initial bolus injection: 10 mg IV followed by an infusion of 50 mg over 60 minutes and then a subsequent infusion of 40 mg over 120 minutes to achieve a maximum total dose of 100 mg.
- For patients less than 65 kg: The cumulative dose should not exceed 1.5 mg/kg.
| Study group | Role | What they receive |
|---|---|---|
| Revelise® (GENERIUM, Russia) | Experimental | аlteplase Receives: Biological: Revelise (GENERIUM, Russia) |
| Actilyse® (Boehringer Ingelheim Pharma GmbH and Co.KG, Germany) | Active comparator | аlteplase Receives: Biological: Actilyse® (Boehringer Ingelheim Pharma GmbH and Co.KG, Germany) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Myocardial reperfusion rate confirmed by the coronary angiography (CAG)
Myocardial reperfusion confirmed by the CAG: coronary blood flow TIMI 3 or 2 degrees are considered to be myocardial reperfusion. Grade 3 - normal coronary perfusion: antegrade blood flow and contrast washout distal to the site of obstruction do not differ from those in an unaffected vessel; grade 2 - incomplete coronary perfusion: complete contrasting of the coronary artery distal to the site of obstruction, however, there is a delay in filling of the distal bed or slowdown in contrast washout).
Measured: In 3 hours after the beginning of IV thrombolysis in case of ECG data of successful reperfusion and immediately - if there is no effect of thrombolysis based on ECG data.
Secondary outcomes (9)
Frequency of percutaneous coronary intervention (PCI)
Frequency of performing PCI after the intravenous thrombolysis results.
Measured: During the first day after the intravenous thrombolysis, but not earlier than 3 hours after the start of the infusion in case of coronary reperfusion and immediately in case of nocoronary thrombolysis based on ECG data
Cardiovascular mortality
Cardiovascular mortality in the period up to 30 days after acute myocardial infarction
Measured: Up to 30 days after acute myocardial infarction
Myocardial reperfusion rate according to ECG data.
Myocardial reperfusion rate according to ECG data - by ST-segment resolution (reduction) by 30%, 50%, 70% or more than 90 minutes after the beginning of the product administration in patients with acute myocardial infarction for up to 6 hours and by ST-segment resolution (reduction) by 50% or more than 180 minutes after the beginning of the product administration in patients with acute myocardial infarction during the period from 6 to 12 hours from the disease onset. (Resolution of ST segment elevation is calculated as follows: the amount (by leads) of ST segment elevation before therapy (at point J) minus the amount of ST segment elevation after therapy (90 or 180 minutes after the beginning of the product administration) divided by the amount of ST segment elevation before therapy and expressed as a percentage.)
Measured: 90 or 180 minutes after the beginning of the IV thrombolysis.
Overall mortality
Any cause mortality after acute myocardial infarction
Measured: Up to 90 days
Incidence of post-infarction complications
Incidence of post-infarction complications (true cardiogenic shock, clinical signs of congestive heart failure, acute left ventricular aneurysm, cardiac rupture, early post-infarction angina, recurrent myocardial infarction, brain infarction) during the first 30 days, except the rhythm disturbances
Measured: 30 days
Incidence of the combined cardiovascular events
Incidence of the combined cardiovascular events "death from cardiovascular diseases + recurrence of myocardial infarction + stroke" and "death from cardiovascular diseases + recurrence of myocardial infarction + stroke + heart failure" within 30 and 90 days after the acute myocardial infarction
Measured: Within 30 and 90 days
Troponin changes
Troponin concentration changes during the first 14 days after acute myocardial infarction
Measured: 14 days
Fibrinogen concentration
Concentration of fibrinogen in plazma sample
Measured: Days 1, 2 and 3
D-dimer concentration
Concentration of the D-dimer in plazma sample
Measured: Days 1, 2 and 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2025
- Study start25 May 2014
- Primary completion21 Nov 2017
- Study completion11 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myocardial Infarction (MI)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- AO GENERIUM
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Oksana A. Markova, MD, Study chair
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07146360
- Sponsor's protocol ID
- REV-STEMI-III
- Status last verified
- Aug 2025
- First submitted
- 15 Aug 2025
- Last updated
- 28 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Randomized, Single-blind, Parallel Group Clinical Trial to Evaluate the Efficacy and Safety of the Revelise® (GENERIUM, Russia) as Compared With the Actilyse® (Boehringer Ingelheim Pharma GmbH and Co.KG, Germany) in Patients With Acute Myocardial Infarction With ST-segment Elevation on ECG
- ClinicalTrials.gov ID
- NCT07146360
- Acronym / sponsor ID
- REV-STEMI-III
- Conditions
- Myocardial Infarction (MI)
- Keywords
- Acute Myocardial Infarction, Thrombosis, Recombinant tissue plasminogen activator, Acute Coronary Syndrome, Coronary Syndrome, Chronic heart failure, Activated partial thromboplastin time, New York Heart Association
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- AO GENERIUMIndustry (pharma, biotech, devices)
- Study start
- 25 May 2014 (actual)
- Primary completion
- 21 Nov 2017 (actual)
- Study completion
- 11 Dec 2017 (actual)
- First posted
- 28 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 with the Actilyse® (Boehringer Ingelheim Pharma GmbH and Co.KG, Germany) in patients with acute myocardial infarction (MI) with ST-segment elevation on the electrocardiogram (ECG). The thrombolisis was performed within the period of up to 6 hours and from 6 to 12 hours from the MI symptoms onset.
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 myocardial infurction, enrolled into the study, have been randomised to receive either biosimilar product or a reference produc. The stratification factor was the time from the MI symptoms onset: 1) within the 6 hours and 2) from 6 to 12 hours. Each patient was then followed-up for 3 months, including up to 14 days in an inpatient facility. Coronary angiography was to be performed within the first 24 hours after the administration of the study products, but not earlier than 3 hours after beginning of infusion in case of confirmed thrombolysis (onset of myocardial reperfusion) and immediately - in the absence of reperfusion according to ECG data (ST-segment reduction by less than 50% afterthe infusion start). The patients' condition will be assessed at the scheduled visits.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Revelise® (GENERIUM, Russia) | Experimental | Biological: Revelise (GENERIUM, Russia)аlteplase |
| Actilyse® (Boehringer Ingelheim Pharma GmbH and Co.KG, Germany) | Active comparator | Biological: Actilyse® (Boehringer Ingelheim Pharma GmbH and Co.KG, Germany)аlteplase |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Revelise (GENERIUM, Russia)1. 90-minute accelerated dosing regimen for patients who can start treatment within 6 hours after the onset of symptoms of acute myocardial infarction (AMI): Initial bolus injection: 15 mg intraveniously (IV) followed by an infusion of 50 mg over 30 minutes and then a subsequent infusion of 35 mg over 60 minutes to reach a maximum total dose of 100 mg. - For patients less than 65 kg: Initial bolus injection: 15 mg IV - 0.75 mg/kg (maximum 50 mg) over 30 minutes followed by an additional infusion of 0.5 mg/kg (maximum 35 mg) over 60 minutes. 2. 3-hour dosing regimen for patients who can start treatment between 6 and 12 hours after symptom onset of AMI: Initial bolus injection: 10 mg IV followed by an infusion of 50 mg over 60 minutes and then a subsequent infusion of 40 mg over 120 minutes to achieve a maximum total dose of 100 mg. * For patients less than 65 kg: The cumulative dose should not exceed 1.5 mg/kg. | Biological | Revelise® (GENERIUM, Russia) |
| Actilyse® (Boehringer Ingelheim Pharma GmbH and Co.KG, Germany)1. 90-minute accelerated dosing regimen for patients who can start treatment within 6 hours after the onset of symptoms of acute myocardial infarction (AMI): Initial bolus injection: 15 mg intraveniously (IV) followed by an infusion of 50 mg over 30 minutes and then a subsequent infusion of 35 mg over 60 minutes to reach a maximum total dose of 100 mg. - For patients less than 65 kg: Initial bolus injection: 15 mg IV - 0.75 mg/kg (maximum 50 mg) over 30 minutes followed by an additional infusion of 0.5 mg/kg (maximum 35 mg) over 60 minutes. 2. 3-hour dosing regimen for patients who can start treatment between 6 and 12 hours after symptom onset of AMI: Initial bolus injection: 10 mg IV followed by an infusion of 50 mg over 60 minutes and then a subsequent infusion of 40 mg over 120 minutes to achieve a maximum total dose of 100 mg. * For patients less than 65 kg: The cumulative dose should not exceed 1.5 mg/kg. | Biological | Actilyse® (Boehringer Ingelheim Pharma GmbH and Co.KG, Germany) |
Primary outcome
Myocardial reperfusion rate confirmed by the coronary angiography (CAG)
Time frame: In 3 hours after the beginning of IV thrombolysis in case of ECG data of successful reperfusion and immediately - if there is no effect of thrombolysis based on ECG data.
Myocardial reperfusion confirmed by the CAG: coronary blood flow TIMI 3 or 2 degrees are considered to be myocardial reperfusion. Grade 3 - normal coronary perfusion: antegrade blood flow and contrast washout distal to the site of obstruction do not differ from those in an unaffected vessel; grade 2 - incomplete coronary perfusion: complete contrasting of the coronary artery distal to the site of obstruction, however, there is a delay in filling of the distal bed or slowdown in contrast washout).
9 secondary outcomes
Frequency of percutaneous coronary intervention (PCI)
Time frame: During the first day after the intravenous thrombolysis, but not earlier than 3 hours after the start of the infusion in case of coronary reperfusion and immediately in case of nocoronary thrombolysis based on ECG data
Cardiovascular mortality
Time frame: Up to 30 days after acute myocardial infarction
Myocardial reperfusion rate according to ECG data.
Time frame: 90 or 180 minutes after the beginning of the IV thrombolysis.
Overall mortality
Time frame: Up to 90 days
Incidence of post-infarction complications
Time frame: 30 days
Incidence of the combined cardiovascular events
Time frame: Within 30 and 90 days
Troponin changes
Time frame: 14 days
Fibrinogen concentration
Time frame: Days 1, 2 and 3
D-dimer concentration
Time frame: Days 1, 2 and 3
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2025.
- Milto A.S., Kokorin V.A., Markova O.A. et. al. Comparative safety and efficacy study of Russian recombinant tissue plazminogen activator Revelisa® in patients with myocardial infarction. Therapy, 2019; 2 \[28\]:42-56Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Oksana A. Markova, MD study chair
22 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Revelise (GENERIUM, Russia) and Actilyse® (Boehringer Ingelheim Pharma GmbH and Co.KG, Germany) in people with Myocardial Infarction (MI), run by AO GENERIUM at 22 sites in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Myocardial reperfusion rate confirmed by the coronary angiography (CAG) (time frame: In 3 hours after the beginning of IV thrombolysis in case of ECG data of successful reperfusion and immediately - if there is no effect of thrombolysis based on ECG data.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2025.