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Active, not recruiting Phase 3

Ivabradine for Prevention of Myocardial Injury After Noncardiac Surgery Trial (PREVENT-MINS)

NCT05279651 · tracked via the Priya Life Science Poland tracker
Phase
Phase 3
Started
2022-06-13
Last updated
2025-09-03

Condition(s) studied

Myocardial Injury After Noncardiac Surgery (MINS)Myocardial Ischemia

Investigational drug(s) / intervention(s)

Ivabradine →Placebo

Ivabradine: 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: 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 summary

This study is a multicentre, randomized controlled trial of ivabradine versus placebo.

Eligibility

Sex
ALL
Min age
45 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: 1. Undergoing noncardiac surgery 2. ≥45 years of age 3. Expected to require at least an overnight hospital admission after surgery 4. Provide written informed consent to participate in the PREVENT-MINS Trial, AND 5. Fulfill ≥1 of the following 5 criteria (A-E): 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: 1. 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 2. Transplanted heart (or on waiting list) 3. Use of a selected class I or III antiarrhythmic drug (quinidine, disopyramide, sotalol, ibutilide, amiodarone) or diltiazem/verapamil 4. Resting heart rate \<65 beats per minute on the day of surgery 5. Systolic blood pressure \<90 mmHg on the day of surgery 6. Acute decompensated heart failure, cardiogenic shock, acute myocarditis 7. Acute coronary syndrome within 2 months before surgery; 8. Stroke or transient cerebral ischaemia within 1 month before surgery 9. Known severe liver or kidney disease (MDRD creatinine clearance \<15 mL/min) 10. Inability to tolerate oral intake 11. Recent use of ivabradine (\<1 month) 12. Known allergy or hypersensitivity to ivabradine 13. Low-risk surgical procedure based on individual physician's judgment 14. Investigator considers the patient unreliable regarding requirement for study compliance 15. Women of childbearing potential who are not taking effective contraception, pregnant or breast-feeding 16. Previously enrolled in the PREVENT-MINS study

Primary outcome measure(s)

  • MINS — 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.

Trial sites (26)

FacilityCityRegionStatus
Szpital Uniwersytecki nr 1 im. dr Antoniego Jurasza w Bydgoszczy Bydgoszcz Poland
Specjalistyczny Szpital Wojewódzki w Ciechanowie Ciechanów Poland
ZZOZ Szpital Śląski w Cieszynie Cieszyn Poland
Uniwersyteckie Centrum Kliniczne Gdańskiego Uniwersytetu Medycznego Gdansk Poland
Szpital Specjalistyczny św. Łukasza w Końskich Gmina Końskie Poland
Uniwersyteckie Centrum Kliniczne im. Prof. Kornela Gibińskiego Śląski Uniwersytet Medyczny Katowice Poland
Szpital św. Rafała w Krakowie Krakow Poland
5 Wojskowy Szpital Kliniczny z Polikliniką Samodzielny Publiczny Zakład Opieki Zdrowotnej w Krakowie Krakow Poland
Szpital Zakonu Bonifratrów św. Jana Grandego w Krakowie Krakow Poland
Krakowski Szpital Specjalistyczny im. Jana Pawła II Krakow Poland
SP ZOZ Szpital Uniwersytecki w Krakowie Krakow Poland
Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie sp. z o.o. Krakow Poland
Szpital Specjalistyczny im. Stefana Żeromskiego w Krakowie Krakow Poland
Centralny Szpital Kliniczny Uniwersytetu Medycznego w Łodzi Lodz Poland
Samodzielny Publiczny Szpital Kliniczny 1 w Lublinie Lublin Poland
Wojewódzki Szpital Specjalistyczny w Olsztynie Olsztyn Poland
Uniwersytecki Szpital Kliniczny w Opolu Opole Poland
Samodzielny Publiczny Szpital Kliniczny Nr 2 Pomorskiego Uniwersytetu Medycznego Szczecin Poland
Samodzielny Publiczny Szpital Kliniczny Nr 1 Pomorskiego Uniwersytetu Medycznego Szczecin Poland
Specjalistyczny Szpital im. Edwarda Szczeklika w Tarnowie Tarnów Poland
Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego Szpital Kliniczny Dzieciątka Jezus Warsaw Poland
Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego Centralny Szpital Kliniczny Warsaw Poland
Wojskowy Instytut Medyczny Centralny Szpital Kliniczny MON Warsaw Poland
Uniwersytecki Szpital Kliniczny we Wrocławiu Wroclaw Poland
Samodzielny Publiczny Szpital Kliniczny Nr 1 im. Prof. Stanisława Szyszko Śląskiego Uniwersytetu Medycznego w Katowicach Zabrze Poland
Szpital Uniwersytecki im. Karola Marcinkowskiego w Zielonej Górze Zielona Góra Poland
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05279651 on ClinicalTrials.gov ↗ ← All trials in Poland