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

NCT05279651 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 2146

Last updated 2025-09-03

No results posted yet for this study

Summary

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

Conditions

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

Interventions

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.

Sponsors & Collaborators

  • Population Health Research Institute

    collaborator OTHER

  • Vanderbilt University Medical Center

    collaborator OTHER

  • Jagiellonian University

    lead OTHER

Principal Investigators

  • Wojciech Szczeklik, Professor · Centre for Intensive Care and Perioperative Medicine, Jagiellonian University Medical College

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
45 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-06-13
Primary Completion
2025-04-30
Completion
2026-06-30

Countries

  • Poland

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05279651 on ClinicalTrials.gov