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NCT05786131 Clinical Trial

Complete Revascularization Versus Culprit Lesion Only PCI in NSTEMI

Multivessel Coronary Artery Disease Clinical Trial

— CompleteNSTEMI  

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05786131
Other study ID # 2023-019
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date October 27, 2023
Est. completion date July 31, 2027

Study information
Verified date March 2024
Source Leipzig Heart Science gGmbH
Contact Holger Thiele, MD, Prof. Dr.
Phone +49 341 865-252025
Email holger.thiele@medizin.uni-leipzig.de
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 3390
Est. completion date July 31, 2027
Est. primary completion date January 31, 2027
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 - Co-morbidity with life expectancy less than 6 months - Type 2 myocardial infarction

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Culprit-lesion revascularization
Percutaneous coronary intervention of culprit-lesion
• Non-culprit-lesion revascularization
Complete percutaneous coronary intervention of all angiographically significant non-culprit lesions

Locations
Country Name City State
Germany Charité - University Medicine Berlin, Department of Internal Medicine and Cardiology, Campus Virchow Klinikum Berlin
Germany University Medical Center Göttingen, Department of Cardiology and Pneumology, Georg-August University Göttingen
Germany Heart Center Leipzig at University of Leipzig, Department of Internal Medicine/Cardiology Leipzig
Germany Universitätsklinikum Leipzig, Klinik und Poliklinik für Kardiologiy Leipzig

Sponsors (5)
Lead Sponsor Collaborator
Leipzig Heart Science gGmbH German Federal Ministry of Education and Research, Heart Center Leipzig at University of Leipzig, IHF GmbH - Institut für Herzinfarktforschung, Stiftung IHF - Institut für Herzinfarktforschung

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary Composite rate of cardiovascular death or rehospitalization for non-fatal myocardial infarction During follow-up (2 years estimated average duration)
Secondary Rate of Cardiovascular death During follow-up (2 years estimated average duration)
Secondary Rate of Rehospitalization for non-fatal myocardial infarction During follow-up (2 years estimated average duration)
Secondary Rate of all-cause death During follow-up (2 years estimated average duration)
Secondary Rate of ischemia-driven revascularization During follow-up (2 years estimated average duration)
Secondary Rate of rehospitalization for heart failure During follow-up (2 years estimated average duration)
Secondary 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)
Secondary Rate of coronary artery bypass surgery During follow-up (2 years estimated average duration)
Secondary Quality of Life (EQ-5D-5L) 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 12 months
Secondary Rate of bleeding 6 months
Secondary Rate of stroke Ischemic and Hemorrhagic 6 months
Secondary Rate of contrast-induced acute kidney injury AKIN grade I-III 6 months
Secondary Rate of coronary procedure-related myocardial infarction 6 months
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