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

• Status: Not yet recruiting
• Trial end date: 2026-03-31
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Jagiellonian University
• Collaborators: Population Health Research Institute; Vanderbilt University Medical Center

Criteria

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