Complete Revascularization Versus Culprit Lesion Only PCI in NSTEMI (-COMPLETE-NSTEMI-)

Leipzig Heart Science gGmbH58 sites in 2 countries3,390 target enrollmentOctober 27, 2023

ConditionsNon-ST-elevation Myocardial Infarction Multivessel Coronary Artery Disease

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Non-ST-elevation Myocardial Infarction
Sponsor: Leipzig Heart Science gGmbH
Enrollment: 3390
Locations: 58
Primary Endpoint: Composite rate of cardiovascular death or rehospitalization for non-fatal myocardial infarction
Status: Recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

Prospective, randomized, controlled, multicenter, open-label trial to study whether multivessel percutaneous coronary intervention (PCI) is superior over culprit-lesion only PCI in patients with non-ST-segment elevation myocardial infarction (NSTEMI) and multivessel coronary artery disease.

Detailed Description

The complete revascularization versus culprit lesion only PCI in NSTEMI (COMPLETE-NSTEMI) trial aims to investigate whether multivessel complete PCI is superior over culprit-lesion only PCI in patients with NSTEMI and multivessel coronary artery disease.

Registry

clinicaltrials.gov

Start Date

October 27, 2023

End Date

July 31, 2027

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Leipzig Heart Science gGmbH

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•NSTEMI as suggested by high-sensitivity troponin algorithms
•Multivessel coronary artery disease
•Identifiable culprit lesion
•Informed consent

Exclusion Criteria

•Age \<18 years
•Cardiogenic shock
•Sustained ventricular tachycardia (VT) or ventricular fibrillation (VF)
•Contraindication for coronary revascularization
•Prior coronary artery bypass graft
•Indication for coronary artery bypass graft surgery
•Non-culprit lesion located in the left main coronary artery
•Co-morbidity with life expectancy less than 6 months
•Type 2 myocardial infarction
•Pregnancy and breast feeding period

Outcomes

Primary Outcomes

Composite rate of cardiovascular death or rehospitalization for non-fatal myocardial infarction

Time Frame: During follow-up (2 years estimated average duration)

Secondary Outcomes

Rate of bleeding(6 months)
Rate of stroke(6 months)
Rate of coronary procedure-related myocardial infarction(6 months)
Rate of all-cause death(During follow-up (2 years estimated average duration))
Rate of ischemia-driven revascularization(During follow-up (2 years estimated average duration))
Rate of coronary artery bypass surgery(During follow-up (2 years estimated average duration))
Rate of Cardiovascular death(During follow-up (2 years estimated average duration))
Rate of rehospitalization for heart failure(During follow-up (2 years estimated average duration))
Composite rate of all-cause death, rehospitalization for non-fatal myocardial infarction, or rehospitalization for ischemia-driven revascularization(During follow-up (2 years estimated average duration))
Rate of Rehospitalization for non-fatal myocardial infarction(During follow-up (2 years estimated average duration))
Quality of Life (EQ-5D-5L)(12 months)
Rate of contrast-induced acute kidney injury(6 months)