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| Name | Class |
|---|---|
| Population Health Research Institute | OTHER |
| Vanderbilt University Medical Center | OTHER |
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This study is a multicentre, randomized controlled trial of ivabradine versus placebo.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ivabradine | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 30 days after randomization |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 30 days after randomization |
| MINS not fulfilling the 4th universal definition of myocardial infarction |
| Measure | Description | Time Frame |
|---|---|---|
| Cardiac revascularization | Number of patients who undergo cardiac revascularization | 30 days after randomization |
| Re-hospitalization for vascular reasons | Number of patients re-hospitalized for vascular reasons |
Inclusion Criteria:
A. History of coronary artery disease B. History of peripheral arterial disease C. History of stroke D. Undergoing major vascular surgery, OR
E. Any 3 of 9 risk criteria:
i. 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
Exclusion Criteria:
Conduction abnormalities:
A. 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
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
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| Name | Affiliation | Role |
|---|---|---|
| Wojciech Szczeklik, Professor | Centre for Intensive Care and Perioperative Medicine, Jagiellonian University Medical College | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Szpital Uniwersytecki nr 1 im. dr Antoniego Jurasza w Bydgoszczy | Bydgoszcz | 85-094 | Poland | |||
| Specjalistyczny Szpital Wojewódzki w Ciechanowie |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41272750 | Derived | 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. | |
| 40884771 |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Nov 19, 2025 | |
| Reset | Dec 12, 2025 |
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Parallel Assignment
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|
| Placebo | Drug | 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. |
|
Number of patients who experience MINS not fulfilling the 4th universal definition of myocardial infarction |
| 30 days after randomization |
| Myocardial infarction | Number of patients who experience a myocardial infarction | 30 days after randomization |
| Vascular death | Number of patients who die of vascular cause | 30 days after randomization |
| Stroke | Number of patients who experience a stroke | 30 days after randomization |
| All-cause mortality | Number of patients who die of any cause | 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 | 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]) | 30 days after randomization |
| Clinically important atrial fibrillation | Number of patients who experience clinically important atrial fibrillation | 30 days after randomization |
| Clinically significant bradycardia | Number of patients who experience clinically significant bradycardia | 30 days after randomization |
| Clinically significant hypotension | Number of patients who experience clinically significant hypotension | 30 days after randomization |
| Phosphenes | Number of patients who experience phosphenes | 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 | 30 days after randomization |
| Peak troponin concentration | Peak troponin concentration during the index hospitalization | 30 days after randomization |
| Area under the curve troponin | Area under the curve of troponin concentrations measured during the hospitalization | 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 | 30 days after randomization |
| Intraoperative heart rate | Intraoperative heart rate measured during the index surgery to calculate the average heart rate | 30 days after randomization |
| 30 days after randomization |
| Acute myocardial injury according to Fourth Universal Definition of Myocardial Infarction | Number of patients who experience an acute myocardial injury according to Fourth Universal Definition of Myocardial Infarction | 30 days after randomization |
| Non-fatal cardiac arrest | Number of patients who experience non-fatal cardiac arrest | 30 days after randomization |
| Acute congestive heart failure | Number of patients who experience acute congestive heart failure | 30 days after randomization |
| Any symptomatic or asymptomatic episode of deep vein thrombosis or pulmonary embolism | Number of patients who experience any (symptomatic or asymptomatic) episode of deep vein thrombosis or pulmonary embolism | 30 days after randomization |
| International Society on Thrombosis and Haemostasis (ISTH) major bleeding | Number of patients who experience major bleeding (as defined by ISTH) | 30 days after randomization |
| BIMS | Number of patients who experience bleeding independently associated with mortality after noncardiac surgery (BIMS) | 30 days after randomization |
| Infection/Sepsis | Number of patients who experience infection/sepsis | 30 days after randomization |
| Acute kidney injury fulfilling Kidney Disease Improving Global Outcomes (KDIGO) criteria | Number of patients who experience an acute kidney injury (fulfilling KDIGO criteria) | 30 days after randomization |
| Acute kidney injury requiring dialysis | Number of patients who experience an acute kidney injury requiring dialysis | 30 days after randomization |
| Amputation | Number of patients who undergo an amputation | 30 days after randomization |
| Days outside of intensive care unit | Average number of days alive outside of intensive care/cardiac care unit within 30 days after randomization | 30 days after randomization |
| Length of hospital stay | Average length of hospital stay | 30 days after randomization |
| Length of intensive care unit stay | Average length of intensive care unit stay | 30 days after randomization |
| Discharge destination from the hospital | Number of patients discharge to home/long-term care facility/other | 30 days after randomization |
| All-cause mortality | Number of patients who die of any cause | 1 year after randomization |
| Vascular death | Number of patients who die of vascular cause | 1 year after randomization |
| Myocardial infarction | Number of patients who experience a myocardial infarction | 1 year after randomization |
| Cardiac revascularization | Number of patients who undergo cardiac revascularization | 1 year after randomization |
| Non-fatal cardiac arrest | Number of patients who experience non-fatal cardiac arrest | 1 year after randomization |
| Stroke | Number of patients who experience a stroke | 1 year after randomization |
| Health-related quality of life | Average health-related quality of life (based on EuroQol 5 Dimension, five-level version [EQ-5D]) | 1 year after randomization |
| Amputation | Number of patients who have an amputation | 1 year after randomization |
| Re-hospitalization for vascular reasons | Number of patients who experience a re-hospitalization for vascular reasons | 1 year after randomization |
| Ciechanów |
| 06-400 |
| Poland |
| ZZOZ Szpital Śląski w Cieszynie | Cieszyn | 43-400 | Poland |
| Uniwersyteckie Centrum Kliniczne Gdańskiego Uniwersytetu Medycznego | Gdansk | 80-952 | Poland |
| Szpital Specjalistyczny św. Łukasza w Końskich | Gmina Końskie | 26-200 | Poland |
| Uniwersyteckie Centrum Kliniczne im. Prof. Kornela Gibińskiego Śląski Uniwersytet Medyczny | Katowice | 40-752 | Poland |
| Szpital św. Rafała w Krakowie | Krakow | 30-693 | Poland |
| 5 Wojskowy Szpital Kliniczny z Polikliniką Samodzielny Publiczny Zakład Opieki Zdrowotnej w Krakowie | Krakow | 30-901 | Poland |
| Szpital Zakonu Bonifratrów św. Jana Grandego w Krakowie | Krakow | 31-061 | Poland |
| Krakowski Szpital Specjalistyczny im. Jana Pawła II | Krakow | 31-202 | Poland |
| SP ZOZ Szpital Uniwersytecki w Krakowie | Krakow | 31-501 | Poland |
| Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie sp. z o.o. | Krakow | 31-826 | Poland |
| Szpital Specjalistyczny im. Stefana Żeromskiego w Krakowie | Krakow | 31-913 | Poland |
| Centralny Szpital Kliniczny Uniwersytetu Medycznego w Łodzi | Lodz | 92-213 | Poland |
| Samodzielny Publiczny Szpital Kliniczny 1 w Lublinie | Lublin | 20-081 | Poland |
| Wojewódzki Szpital Specjalistyczny w Olsztynie | Olsztyn | 10-561 | Poland |
| Uniwersytecki Szpital Kliniczny w Opolu | Opole | 45-401 | Poland |
| Samodzielny Publiczny Szpital Kliniczny Nr 2 Pomorskiego Uniwersytetu Medycznego | Szczecin | 70-111 | Poland |
| Samodzielny Publiczny Szpital Kliniczny Nr 1 Pomorskiego Uniwersytetu Medycznego | Szczecin | 72-252 | Poland |
| Specjalistyczny Szpital im. Edwarda Szczeklika w Tarnowie | Tarnów | 33-100 | Poland |
| Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego Szpital Kliniczny Dzieciątka Jezus | Warsaw | 02-005 | Poland |
| Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego Centralny Szpital Kliniczny | Warsaw | 02-097 | Poland |
| Wojskowy Instytut Medyczny Centralny Szpital Kliniczny MON | Warsaw | 04-141 | Poland |
| Uniwersytecki Szpital Kliniczny we Wrocławiu | Wroclaw | 50-556 | Poland |
| Samodzielny Publiczny Szpital Kliniczny Nr 1 im. Prof. Stanisława Szyszko Śląskiego Uniwersytetu Medycznego w Katowicach | Zabrze | 41-800 | Poland |
| Szpital Uniwersytecki im. Karola Marcinkowskiego w Zielonej Górze | Zielona Góra | 65-001 | Poland |
| Derived |
| 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, 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. |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Nov 19, 2025 | Dec 12, 2025 |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D002318 | Cardiovascular Diseases |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D000077550 | Ivabradine |
| ID | Term |
|---|---|
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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