Myocardial Injury After Noncardiac Surgery (MINS)Phase 3PREVENT-MINSNCT05279651
Ivabradine for Prevention of Myocardial Injury After Noncardiac Surgery Trial (PREVENT-MINS)
A Phase 3 study testing Ivabradine in people with Myocardial Injury After Noncardiac Surgery (MINS) and Myocardial Ischemia, run by Jagiellonian University at 26 sites in Poland.
Trial summary
This study is a multicentre, randomized controlled trial of ivabradine versus placebo. Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Myocardial Injury After Noncardiac Surgery (MINS), Myocardial Ischemia
- What is being tested?
- Ivabradine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 2,146 participants
- Where
- 26 sitesPoland
- Study dates
- 13 Jun 2022to 30 Jun 2026
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Undergoing noncardiac surgery
- ≥45 years of age
- Expected to require at least an overnight hospital admission after surgery
- Provide written informed consent to participate in the PREVENT-MINS Trial, AND
- Fulfill ≥1 of the following 5 criteria (A-E):
- History of coronary artery disease B. History of peripheral arterial disease C. History of stroke D. Undergoing major vascular surgery, OR
- Any 3 of 9 risk criteria:
- Undergoing major surgery ii. History of congestive heart failure iii. History of a transient ischaemic attack iv. Diabetes and currently taking an oral hypoglycemic agent or insulin v. Age ≥70 years vi. History of hypertension vii. Serum creatinine >175 µmol/L (>2.0 mg/dl) viii. History of smoking within 2 years of surgery ix. Undergoing emergent/urgent surgery
Who cannot join
- Conduction abnormalities:
- Non-sinus rhythm on ECG B. Sinoatrial or AV (2nd and 3d degree) blocks C. Sick sinus syndrome D. Long QT syndrome E. Pacemaker dependent
- Transplanted heart (or on waiting list)
- Use of a selected class I or III antiarrhythmic drug (quinidine, disopyramide, sotalol, ibutilide, amiodarone) or diltiazem/verapamil
- Resting heart rate <65 beats per minute on the day of surgery
- Systolic blood pressure <90 mmHg on the day of surgery
Show all 17Show fewer
- Acute decompensated heart failure, cardiogenic shock, acute myocarditis
- Acute coronary syndrome within 2 months before surgery;
- Stroke or transient cerebral ischaemia within 1 month before surgery
- Known severe liver or kidney disease (MDRD creatinine clearance <15 mL/min)
- Inability to tolerate oral intake
- Recent use of ivabradine (<1 month)
- Known allergy or hypersensitivity to ivabradine
- Low-risk surgical procedure based on individual physician's judgment
- Investigator considers the patient unreliable regarding requirement for study compliance
- Women of childbearing potential who are not taking effective contraception, pregnant or breast-feeding
- Previously enrolled in the PREVENT-MINS study
Trial locations and contacts
26 sites in 1 country.
26 sites in 1 country
Poland26 sites
Szpital Uniwersytecki nr 1 im. dr Antoniego Jurasza w Bydgoszczy
Bydgoszcz, 85-094
Specjalistyczny Szpital Wojewódzki w Ciechanowie
Ciechanów, 06-400
ZZOZ Szpital Śląski w Cieszynie
Cieszyn, 43-400
Uniwersyteckie Centrum Kliniczne Gdańskiego Uniwersytetu Medycznego
Gdansk, 80-952
Szpital Specjalistyczny św. Łukasza w Końskich
Gmina Końskie, 26-200
Uniwersyteckie Centrum Kliniczne im. Prof. Kornela Gibińskiego Śląski Uniwersytet Medyczny
Katowice, 40-752
Szpital św. Rafała w Krakowie
Krakow, 30-693
5 Wojskowy Szpital Kliniczny z Polikliniką Samodzielny Publiczny Zakład Opieki Zdrowotnej w Krakowie
Krakow, 30-901
Szpital Zakonu Bonifratrów św. Jana Grandego w Krakowie
Krakow, 31-061
Krakowski Szpital Specjalistyczny im. Jana Pawła II
Krakow, 31-202
SP ZOZ Szpital Uniwersytecki w Krakowie
Krakow, 31-501
Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie sp. z o.o.
Krakow, 31-826
Szpital Specjalistyczny im. Stefana Żeromskiego w Krakowie
Krakow, 31-913
Centralny Szpital Kliniczny Uniwersytetu Medycznego w Łodzi
Lodz, 92-213
Samodzielny Publiczny Szpital Kliniczny 1 w Lublinie
Lublin, 20-081
Wojewódzki Szpital Specjalistyczny w Olsztynie
Olsztyn, 10-561
Uniwersytecki Szpital Kliniczny w Opolu
Opole, 45-401
Samodzielny Publiczny Szpital Kliniczny Nr 2 Pomorskiego Uniwersytetu Medycznego
Szczecin, 70-111
Samodzielny Publiczny Szpital Kliniczny Nr 1 Pomorskiego Uniwersytetu Medycznego
Szczecin, 72-252
Specjalistyczny Szpital im. Edwarda Szczeklika w Tarnowie
Tarnów, 33-100
Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego Szpital Kliniczny Dzieciątka Jezus
Warsaw, 02-005
Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego Centralny Szpital Kliniczny
Warsaw, 02-097
Wojskowy Instytut Medyczny Centralny Szpital Kliniczny MON
Warsaw, 04-141
Uniwersytecki Szpital Kliniczny we Wrocławiu
Wroclaw, 50-556
Samodzielny Publiczny Szpital Kliniczny Nr 1 im. Prof. Stanisława Szyszko Śląskiego Uniwersytetu Medycznego w Katowicach
Zabrze, 41-800
Szpital Uniwersytecki im. Karola Marcinkowskiego w Zielonej Górze
Zielona Góra, 65-001
About this study
Official title: Ivabradine for PREVENTion of Myocardial Injury After Noncardiac Surgery
This study is a multicentre, randomized controlled trial of ivabradine versus placebo.
Read the detailed description
The PREVENT-MINS study is a 2,500 patient multicentre, superiority randomized controlled trial of ivabradine versus placebo. The primary objective of the trial is to determine the impact of ivabradine versus placebo on the risk of MINS in patients with or at risk of atherosclerotic disease who are followed for 30 days after noncardiac surgery.
- Being tested
- Ivabradine, Placebo
- Keywords
- Myocardial ischemia, Randomized controlled trial, Blinded, Noncardiac surgery, Cardiovascular events, Myocardial injury after non-cardiac surgery, Perioperative myocardial injury, Perioperative myocardial infarction, Perioperative medicine, Heart rate, Ivabradine, Cardiovascular Diseases, Troponin, Perioperative care, Physiological Effects of Drugs, Cardiovascular Agents, Cardiac Chronotropy, Heart Rate Control
- Medical subject headings
- Myocardial Ischemia, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IvabradineDrug
Patients fulfilling haemodynamic requirements (i.e. systolic blood pressure ≥90 mmHg and sinus rhythm with a heart rate ≥65 beats per minute) will receive 5mg of oral ivabradine at least 1 hour before surgery and the first postoperative dose in the evening or in the morning after surgery, at least 12 hours after the preoperative dose. Starting on the day after surgery, patients will receive 5mg oral ivabradine twice a day and continue this treatment for 7 days after surgery or until hospital discharge.
PlaceboDrug
Patients fulfilling haemodynamic requirements (i.e. systolic blood pressure ≥90 mmHg and sinus rhythm with a heart rate ≥65 beats per minute) will receive matching placebo at least 1 hour before surgery and the first postoperative dose in the evening or in the morning after surgery, at least 12 hours after the preoperative dose. Starting on the day after surgery, patients will receive matching placebo twice a day and continue this treatment for 7 days after surgery or until hospital discharge.
| Study group | Role | What they receive |
|---|---|---|
| Ivabradine | Active comparator | Patients fulfilling haemodynamic requirements (i.e. systolic blood pressure ≥90 mmHg and sinus rhythm with a heart rate ≥65 beats per minute) will receive 5mg of oral ivabradine at least 1 hour before surgery and the first postoperative dose in the evening or in the morning after surgery, at least 12 hours after the preoperative dose. Starting on the day after surgery, patients will receive 5mg oral ivabradine twice a day and continue this treatment for 7 days after surgery or until hospital discharge. Receives: Drug: Ivabradine |
| Placebo | Placebo comparator | Patients fulfilling haemodynamic requirements (i.e. systolic blood pressure ≥90 mmHg and sinus rhythm with a heart rate ≥65 beats per minute) will receive matching placebo at least 1 hour before surgery and the first postoperative dose in the evening or in the morning after surgery, at least 12 hours after the preoperative dose. Starting on the day after surgery, patients will receive matching placebo twice a day and continue this treatment for 7 days after surgery or until hospital discharge. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
MINS
Number of patients who experience myocardial injury after non-cardiac surgery (MINS) defined as any myocardial infarction and any elevated postoperative cardiac troponin judged as resulting from myocardial ischaemia during or within 30 days after noncardiac surgery.
Measured: 30 days after randomization
Secondary outcomes (17)
A composite of vascular death, non-fatal MINS, non-fatal stroke, and non-fatal cardiac arrest
Number of patients who have at least one of the following: vascular death, non-fatal MINS, non-fatal stroke, and non-fatal cardiac arrest
Measured: 30 days after randomization
MINS not fulfilling the 4th universal definition of myocardial infarction
Number of patients who experience MINS not fulfilling the 4th universal definition of myocardial infarction
Measured: 30 days after randomization
Myocardial infarction
Number of patients who experience a myocardial infarction
Measured: 30 days after randomization
Vascular death
Number of patients who die of vascular cause
Measured: 30 days after randomization
Stroke
Number of patients who experience a stroke
Measured: 30 days after randomization
All-cause mortality
Number of patients who die of any cause
Measured: 30 days after randomization
Days alive and at home
Average number of days when a patient is alive and out of hospital within 30 days after randomization
Measured: 30 days after randomization
Health-related quality of life
Average health-related quality of life (based on EuroQol 5 Dimension, five-level version [EQ-5D])
Measured: 30 days after randomization
Clinically important atrial fibrillation
Number of patients who experience clinically important atrial fibrillation
Measured: 30 days after randomization
Clinically significant bradycardia
Number of patients who experience clinically significant bradycardia
Measured: 30 days after randomization
Clinically significant hypotension
Number of patients who experience clinically significant hypotension
Measured: 30 days after randomization
Phosphenes
Number of patients who experience phosphenes
Measured: 30 days after randomization
Cancellation or postponement of surgery due to concerns about patient's heart rate
Number of surgeries cancelled or postponed due to heart rate concerns
Measured: 30 days after randomization
Peak troponin concentration
Peak troponin concentration during the index hospitalization
Measured: 30 days after randomization
Area under the curve troponin
Area under the curve of troponin concentrations measured during the hospitalization
Measured: 30 days after randomization
Intraoperative mean arterial pressure
Intraoperative mean arterial pressure measured during the index surgery to calculate the average intraoperative mean arterial pressure
Measured: 30 days after randomization
Intraoperative heart rate
Intraoperative heart rate measured during the index surgery to calculate the average heart rate
Measured: 30 days after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2022
- Study start13 Jun 2022
- Primary completion30 Apr 2025
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Myocardial Injury After Noncardiac Surgery (MINS)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
- Model description
- Parallel Assignment
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 2,146 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jagiellonian University
- Sponsor type
- University, hospital or other
- Collaborators
- Population Health Research Institute, Vanderbilt University Medical Center
- Responsible party
- Principal investigator, Wojciech Szczeklik, Jagiellonian University
- Investigators
- Wojciech Szczeklik, Professor, Principal investigator, Centre for Intensive Care and Perioperative Medicine, Jagiellonian University Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05279651
- Sponsor's protocol ID
- PREVENT-MINS
- Acronym
- PREVENT-MINS
- Status last verified
- Mar 2025
- First submitted
- 4 Mar 2022
- Last updated
- 3 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Szczeklik W, Fronczek J, Putowski Z, Wludarczyk A, Gorka J, Seczynska B, Gryszowka D, Widawska A, Bialka S, Palaczynski P, Borys M, Kutnik P, Czarnik T, Krolicki T, Szczepanska A, Hajder N, Mozanski M, Onichimowski D, Kotfis K, Trzebicki J, Sadowski L, Solek-Pastuszka J, Grudzien P, Mudyna W, Misiewska-Kaczur A, Owczuk R, Kudlinski B, Studzinska D, Pawlik J, Makowski A, Zietkiewicz M, Przydacz M, Gozdzik W, Gola W, Jasiewicz P, Zhao Z, Shyr Y, Devereaux PJ. Ivabradine for prevention of myocardial injury after noncardiac surgery (PREVENT-MINS trial): study protocol for a randomized controlled trial. Trials. 2025 Nov 21;26(1):533. doi: 10.1186/s13063-025-09087-z.
PubMed 41272750Szczeklik W, Fronczek J, Putowski Z, Wludarczyk A, Gorka J, Seczynska B, Gryszowka D, Widawska A, Bialka S, Palaczynski P, Borys M, Kutnik P, Czarnik T, Szczepanska A, Mozanski M, Mieszkowski M, Kotfis K, Trzebicki J, Sadowski L, Solek-Pastuszka J, Grudzien P, Mudyna W, Misiewska-Kaczur A, Owczuk R, Kudlinski B, Studzinska D, Pawlik J, Makowski A, Zietkiewicz M, Przydacz M, Gozdzik W, Gola W, Jasiewicz P, Zhao Z, Shyr Y, Devereaux PJ; PERI-CRIT Investigators. Ivabradine in Patients Undergoing Noncardiac Surgery: A Randomized Controlled Trial. Circulation. 2025 Oct 21;152(16):1126-1135. doi: 10.1161/CIRCULATIONAHA.125.076704. Epub 2025 Aug 30.
PubMed 40884771
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ivabradine for PREVENTion of Myocardial Injury After Noncardiac Surgery
- ClinicalTrials.gov ID
- NCT05279651
- Acronym / sponsor ID
- PREVENT-MINS / PREVENT-MINS
- Keywords
- Myocardial ischemia, Randomized controlled trial, Blinded, Noncardiac surgery, Cardiovascular events, Myocardial injury after non-cardiac surgery, Perioperative myocardial injury, Perioperative myocardial infarction
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 2,146 participants (actual)
- Lead sponsor
- Jagiellonian UniversityUniversity, hospital or other
- Collaborators
- Population Health Research Institute, Vanderbilt University Medical Center
- Study start
- 13 Jun 2022 (actual)
- Primary completion
- 30 Apr 2025 (actual)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 15 Mar 2022 (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.
This study is a multicentre, randomized controlled trial of ivabradine versus placebo.
Detailed description
The PREVENT-MINS study is a 2,500 patient multicentre, superiority randomized controlled trial of ivabradine versus placebo. The primary objective of the trial is to determine the impact of ivabradine versus placebo on the risk of MINS in patients with or at risk of atherosclerotic disease who are followed for 30 days after noncardiac surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Parallel Assignment
| Arm | Type | Receives |
|---|---|---|
| Ivabradine | Active comparator | Drug: IvabradinePatients fulfilling haemodynamic requirements (i.e. systolic blood pressure ≥90 mmHg and sinus rhythm with a heart rate ≥65 beats per minute) will receive 5mg of oral ivabradine at least 1 hour before surgery and the first postoperative dose in the evening or in the morning after surgery, at least 12 hours after the preoperative dose. Starting on the day after surgery, patients will receive 5mg oral ivabradine twice a day and continue this treatment for 7 days after surgery or until hospital discharge. |
| Placebo | Placebo comparator | Drug: PlaceboPatients fulfilling haemodynamic requirements (i.e. systolic blood pressure ≥90 mmHg and sinus rhythm with a heart rate ≥65 beats per minute) will receive matching placebo at least 1 hour before surgery and the first postoperative dose in the evening or in the morning after surgery, at least 12 hours after the preoperative dose. Starting on the day after surgery, patients will receive matching placebo twice a day and continue this treatment for 7 days after surgery or until hospital discharge. |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Undergoing noncardiac surgery
- ≥45 years of age
- Expected to require at least an overnight hospital admission after surgery
- Provide written informed consent to participate in the PREVENT-MINS Trial, AND
- Fulfill ≥1 of the following 5 criteria (A-E):
Key exclusion criteria (17 listed)
- Conduction abnormalities:
- Transplanted heart (or on waiting list)
- Use of a selected class I or III antiarrhythmic drug (quinidine, disopyramide, sotalol, ibutilide, amiodarone) or diltiazem/verapamil
- Resting heart rate <65 beats per minute on the day of surgery
- Systolic blood pressure <90 mmHg on the day of surgery
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 |
|---|---|---|
| IvabradinePatients fulfilling haemodynamic requirements (i.e. systolic blood pressure ≥90 mmHg and sinus rhythm with a heart rate ≥65 beats per minute) will receive 5mg of oral ivabradine at least 1 hour before surgery and the first postoperative dose in the evening or in the morning after surgery, at least 12 hours after the preoperative dose. Starting on the day after surgery, patients will receive 5mg oral ivabradine twice a day and continue this treatment for 7 days after surgery or until hospital discharge. | Drug | Ivabradine |
| PlaceboPatients fulfilling haemodynamic requirements (i.e. systolic blood pressure ≥90 mmHg and sinus rhythm with a heart rate ≥65 beats per minute) will receive matching placebo at least 1 hour before surgery and the first postoperative dose in the evening or in the morning after surgery, at least 12 hours after the preoperative dose. Starting on the day after surgery, patients will receive matching placebo twice a day and continue this treatment for 7 days after surgery or until hospital discharge. | Drug | Placebo |
Primary outcome
MINS
Time frame: 30 days after randomization
Number of patients who experience myocardial injury after non-cardiac surgery (MINS) defined as any myocardial infarction and any elevated postoperative cardiac troponin judged as resulting from myocardial ischaemia during or within 30 days after noncardiac surgery.
17 secondary outcomes
A composite of vascular death, non-fatal MINS, non-fatal stroke, and non-fatal cardiac arrest
Time frame: 30 days after randomization
MINS not fulfilling the 4th universal definition of myocardial infarction
Time frame: 30 days after randomization
Myocardial infarction
Time frame: 30 days after randomization
Vascular death
Time frame: 30 days after randomization
Stroke
Time frame: 30 days after randomization
All-cause mortality
Time frame: 30 days after randomization
Days alive and at home
Time frame: 30 days after randomization
Health-related quality of life
Time frame: 30 days after randomization
Clinically important atrial fibrillation
Time frame: 30 days after randomization
Clinically significant bradycardia
Time frame: 30 days after randomization
Clinically significant hypotension
Time frame: 30 days after randomization
Phosphenes
Time frame: 30 days after randomization
Cancellation or postponement of surgery due to concerns about patient's heart rate
Time frame: 30 days after randomization
Peak troponin concentration
Time frame: 30 days after randomization
Area under the curve troponin
Time frame: 30 days after randomization
Intraoperative mean arterial pressure
Time frame: 30 days after randomization
Intraoperative heart rate
Time frame: 30 days after randomization
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2025.
- Derived from this study: PubMed 41272750Szczeklik W, Fronczek J, Putowski Z, Wludarczyk A, Gorka J, Seczynska B, Gryszowka D, Widawska A, Bialka S, Palaczynski P, Borys M, Kutnik P, Czarnik T, Krolicki T, Szczepanska A, Hajder N, Mozanski M, Onichimowski D, Kotfis K, Trzebicki J, Sadowski L, Solek-Pastuszka J, Grudzien P, Mudyna W, Misiewska-Kaczur A, Owczuk R, Kudlinski B, Studzinska D, Pawlik J, Makowski A, Zietkiewicz M, Przydacz M, Gozdzik W, Gola W, Jasiewicz P, Zhao Z, Shyr Y, Devereaux PJ. Ivabradine for prevention of myocardial injury after noncardiac surgery (PREVENT-MINS trial): study protocol for a randomized controlled trial. Trials. 2025 Nov 21;26(1):533. doi: 10.1186/s13063-025-09087-z.
- Derived from this study: PubMed 40884771Szczeklik W, Fronczek J, Putowski Z, Wludarczyk A, Gorka J, Seczynska B, Gryszowka D, Widawska A, Bialka S, Palaczynski P, Borys M, Kutnik P, Czarnik T, Szczepanska A, Mozanski M, Mieszkowski M, Kotfis K, Trzebicki J, Sadowski L, Solek-Pastuszka J, Grudzien P, Mudyna W, Misiewska-Kaczur A, Owczuk R, Kudlinski B, Studzinska D, Pawlik J, Makowski A, Zietkiewicz M, Przydacz M, Gozdzik W, Gola W, Jasiewicz P, Zhao Z, Shyr Y, Devereaux PJ; PERI-CRIT Investigators. Ivabradine in Patients Undergoing Noncardiac Surgery: A Randomized Controlled Trial. Circulation. 2025 Oct 21;152(16):1126-1135. doi: 10.1161/CIRCULATIONAHA.125.076704. Epub 2025 Aug 30.
- 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.
Wojciech Szczeklik, Professor principal investigator
Centre for Intensive Care and Perioperative Medicine, Jagiellonian University Medical College
26 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 Ivabradine in people with Myocardial Injury After Noncardiac Surgery (MINS) and Myocardial Ischemia, run by Jagiellonian University at 26 sites in Poland.
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 8 inclusion and 17 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: under way, not looking for participants, as of the sponsor's last update on 3 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 26 sites in Poland. 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
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?
MINS (time frame: 30 days after randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05279651, which also lists 2 linked publications.
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 3 Sep 2025.