NCT05279651

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

Ivabradine for PREVENTion of Myocardial Injury After Noncardiac Surgery

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 2,146 (actual)
• Sponsor: Jagiellonian University · Academic / Other
• Sex: All
• Age: 45 Years
• Healthy volunteers: Not accepted

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 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.

Conditions

• Myocardial Injury After Noncardiac Surgery (MINS)
• Myocardial Ischemia

Interventions

Type	Name	Description
DRUG	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.
DRUG	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.

Timeline

• Start date: 2022-06-13
• Primary completion: 2025-04-30
• Completion: 2026-06-30
• First posted: 2022-03-15
• Last updated: 2025-09-03

Locations

26 sites across 1 country: Poland