Complete Revascularization Versus Culprit Lesion Only PCI in NSTEMI

Not Applicable

Recruiting

• Conditions: Non-ST-elevation Myocardial Infarction; Multivessel Coronary Artery Disease

• Registration Number: NCT05786131
• Lead Sponsor: Leipzig Heart Science gGmbH

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.

Study Timeline

• Study First Submitted: 2023-03-14
• Study First Submitted QC: 2023-03-14
• Study First Posted: 2023-03-27
• Study Start: 2023-10-27
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-15
• Last Update Posted: 2025-01-16
• Primary Completion: 2027-01-31
• Study Completion: 2027-07-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 3390

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Composite rate of cardiovascular death or rehospitalization for non-fatal myocardial infarction	During follow-up (2 years estimated average duration)

Secondary Outcome Measures

Name	Time	Method
Rate of stroke	6 months	Ischemic and Hemorrhagic
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)
Quality of Life (EQ-5D-5L)	12 months	European Quality of Life 5 Dimensions 5 Level (EQ-5D-5L) Score 1-5 for each dimension, 1 means best outcome EQ VAS score between 0 and 100; higher score means better outcome
Rate of Rehospitalization for non-fatal myocardial infarction	During follow-up (2 years estimated average duration)
Rate of bleeding	6 months
Rate of contrast-induced acute kidney injury	6 months	AKIN grade I-III

Trial Locations

Locations (58)

LKH Univ. Klinikum Graz, Clinical Department of Cardiology; 🇦🇹 Graz, Austria

Medizinische Universität Innsbruck, Universitätsklinik für Innere Medizin III; 🇦🇹 Innsbruck, Austria

Klinik Ottakring, 3. medizinische Abteilung; 🇦🇹 Wien, Austria

Zentralklinik Bad Berka, Klinik für Kardiologie; 🇩🇪 Bad Berka, Germany

Universitäts-Herzzentrum Bad Krozingen, Klinik für Kardiologie und Angiologie; 🇩🇪 Bad Krozingen, Germany

Kerckhoff Klinik; 🇩🇪 Bad Nauheim, Germany

Herz- und Diabeteszentrum NRW, Universitätsklinikum der Ruhr-Universität Bochum, Klinik für Allgemeine und Interventionelle Kardiologie/Angiologie; 🇩🇪 Bad Oeynhausen, Germany

BG Klinikum Unfallkrankenhaus Berlin gGmbH, Klinik für Innere Medizin/Kardiologie; 🇩🇪 Berlin, Germany

Charité - University Medicine Berlin, Department of Internal Medicine and Cardiology, Campus Virchow Klinikum; 🇩🇪 Berlin, Germany

Klinikum Bielefeld gem. GmbH, Klinik für Kardiologie und Internistische Intensivmedizin; 🇩🇪 Bielefeld, Germany

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