Status:
ACTIVE_NOT_RECRUITING
Ivabradine for Prevention of Myocardial Injury After Noncardiac Surgery Trial (PREVENT-MINS)
Lead Sponsor:
Jagiellonian University
Collaborating Sponsors:
Population Health Research Institute
Vanderbilt University Medical Center
Conditions:
Myocardial Injury After Noncardiac Surgery (MINS)
Myocardial Ischemia
Eligibility:
All Genders
45+ years
Phase:
PHASE3
Brief Summary
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...
Eligibility Criteria
Inclusion
- 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):
- 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
- 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
Key Trial Info
Start Date :
June 13 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2026
Estimated Enrollment :
2146 Patients enrolled
Trial Details
Trial ID
NCT05279651
Start Date
June 13 2022
End Date
June 30 2026
Last Update
September 3 2025
Active Locations (26)
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1
Szpital Uniwersytecki nr 1 im. dr Antoniego Jurasza w Bydgoszczy
Bydgoszcz, Poland, 85-094
2
Specjalistyczny Szpital Wojewódzki w Ciechanowie
Ciechanów, Poland, 06-400
3
ZZOZ Szpital Śląski w Cieszynie
Cieszyn, Poland, 43-400
4
Uniwersyteckie Centrum Kliniczne Gdańskiego Uniwersytetu Medycznego
Gdansk, Poland, 80-952