Complete Revascularization Versus Culprit Lesion Only PCI in NSTEMI (-COMPLETE-NSTEMI-)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 3,390
- 试验地点
- 116
- 主要终点
- Composite rate of cardiovascular death or rehospitalization for non-fatal myocardial infarction
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •NSTEMI as suggested by high-sensitivity troponin algorithms
- •Multivessel coronary artery disease
- •Identifiable culprit lesion
- •Informed consent
排除标准
- •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
研究组 & 干预措施
culprit-lesion-only revascularization
Patients will receive optimal medical therapy without further revascularization of non-culprit lesions (neither during index hospitalization nor during follow-up). Angina pectoris will be treated medically as recommended in the chronic coronary syndrome guidelines. Revascularization of non-culprit lesions will only be permitted if at least one bailout criteria is met.
干预措施: Culprit-lesion revascularization (Procedure)
multivessel complete revascularization
Patients will receive complete revascularization of all angiographically significant non-culprit lesions, either during the index procedure, the index hospitalization, or staged within 45 days after PCI of the culprit lesion.
干预措施: Culprit-lesion revascularization (Procedure)
multivessel complete revascularization
Patients will receive complete revascularization of all angiographically significant non-culprit lesions, either during the index procedure, the index hospitalization, or staged within 45 days after PCI of the culprit lesion.
干预措施: Non-culprit-lesion revascularization (Procedure)
结局指标
主要结局
Composite rate of cardiovascular death or rehospitalization for non-fatal myocardial infarction
时间窗: During follow-up (2 years estimated average duration)
次要结局
- 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)