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Ivabradine for PREVENTion of Myocardial Injury after Noncardiac Surgery (MINS) - PREVENT-MINS Trial

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-515226-81-00
Acronym
PREVENT-MINS
Enrollment
2500
Registered
2024-11-05
Start date
2022-06-02
Completion date
Unknown
Last updated
2025-11-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myocardial Injury after Noncardiac Surgery

Brief summary

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

Detailed description

Secondary outcomes at 30 days include: a composite of vascular death, non-fatal MINS, non-fatal stroke, and non-fatal cardiac arrest; vascular death; MINS not fulfilling the criteria of myocardial infarction; myocardial infarction; days alive and at home; stroke, health-related quality of life; cancellation/postponement of surgery on the day of surgery due to HR concerns; intraoperative mean arterial pressure; intraoperative heart rate; clinically important atrial fibrillation; safety outcomes including clinically significant bradycardia, clinically significant hypotension and phosphenes.

Interventions

DRUGIvabradine Anpharm 5 mg film-coated tablets
DRUGPlacebo: lactose monohydrate
DRUGmicrocrystalline cellulose
DRUGmaltodextrin
DRUGmagnesium stearate Capsule: Beef gelatin

Sponsors

Uniwersytet Jagiellonski Collegium Medicum
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
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

Secondary

MeasureTime frame
Secondary outcomes at 30 days include: a composite of vascular death, non-fatal MINS, non-fatal stroke, and non-fatal cardiac arrest; vascular death; MINS not fulfilling the criteria of myocardial infarction; myocardial infarction; days alive and at home; stroke, health-related quality of life; cancellation/postponement of surgery on the day of surgery due to HR concerns; intraoperative mean arterial pressure; intraoperative heart rate; clinically important atrial fibrillation; safety outcomes including clinically significant bradycardia, clinically significant hypotension and phosphenes.

Countries

Poland

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026