Routinely Deferred Versus Early Invasive Strategy in Chinese Patients of 75 Years or Older With Non-ST-elevation Myocardial Infarction - a Multicenter, Open-label, Randomized Controlled Clinical Trial.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 696
- 试验地点
- 1
- 主要终点
- Composite endpoint of all-cause mortality, non-lethal myocardial infarction, stroke and urgent revascularization
研究概览
简要总结
This study is to evaluate the efficacy and safety of a routinely deferred invasive strategy in comparison with an early invasive strategy in Chinese elderly patients of 75 years or older with non-ST elevation myocardial infarction, aiming to test the hypothesis that routinely deferred invasive strategy is not inferior to early invasive strategy in such an elderly group of patients.
详细描述
This study aims to enroll 696 elderly patients with non-ST elevation myocardial infarction (NSTEMI) from 20 hospitals throughout mainland China.. Consective patients of 75 years or older with a diagnosis of NSTEMI will be suitable for enrollment. Written informed consent form will be obtained from every patients. Initially stabilized patients with an ischemic episode within 24 hours before admission will be randomized and others will be registered. For randomization, the patients' brief information will be entered in a central randomization system to generate a random number.
According to the random number, each patient will be randomly assigned to early invasive therapy versus routinely deferred invasive strategy. All patients will initiate dual antiplatelet therapy (aspirin+P2Y12 inhibitor) and continued till the end of follow-up at one year. For patients assigned to early invasive group, a loading dose of antiplatelet agent should be given, unless contraindicated. Anticoagulation, anti-ischemic agents, statin and other guideline recommended medicine will be given according to physician in charge according to guideline.
Patients assigned to early invasive strategy will undergo coronary angiography within 24 hours after admission and have percutaneous coronary intervention or coronary artery bypass grafting as soon as possible during the index hospitalization if appropriate. Patients assigned to deferred invasive strategy will undergo coronary angiography and subsequent revascularization after at lest 72 hours after admission and in the index hospitalization. Patients who undergo percutaneous coronary intervention can receive a glycoprotein IIb/IIIa inhibitor if indicated and upfront use of glycoprotein IIb/IIIa inhibitors is discouraged. The choice of intervention or surgery and the choice of complete or staged revascularization will be determined by the operator according to coronary anatomy and consistent with current practice guidelines. Patients assigned to deferred strategy should undergo urgent coronary angiography and revascularization accordingly if indicated during the period of time waiting for catheterization. Such procedure will be adjudicated as an endpoint. Elective percutaneous coronary intervention on non-culprit vessels, in either study arm, can take place sometime after the index procedure with the goal to achieve complete revascularization. Such staged procedures will not be deemed as an adverse event.
Specific data for acquisition:
Research demographics: age, height, weight, body mass index, medications at randomization, pertinent medical/family/social history, i.e., hypertension, hypercholesterolemia, diabetes mellitus, current tobacco use, history of prior myocardial infarction, PCI or CABG. This data will be gathered by research coordinator through interviewing patient and checking patient's medical record.
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
- 75 Years 至 —(Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 75 years or older
- •Elevated cardiac troponin;
- •Ischemic symptom or ST-segment depression in ECG;
- •Newly onset of myocardial ischemia within 24 hours;
- •Written Informed Consent obtained.
排除标准
- •Type 2 MI (secondary to tachyarrhythmias, uncontrolled hypertension, anemia, hyperthyroidism, acute pulmonary infection, or fever)
- •Secondary elevation of cardiac troponin (e.g. renal insufficiency, heart failure, et al.)
- •Persistent ST-segment elevation or new pathologic Q wave indicating STEMI
- •Ongoing myocardial ischemia despite intensive medical treatment after admission
- •Refractory acute heart failure that can not be well controlled despite treatment for 24 hours
- •Hemodynamic instability or cardiac shock on admission
- •History of cardiac arrest or ventricular tachycardia/fibrillation after symptom onset
- •Concomitant use of oral anticoagulants for atrial fibrillation or thromboembolism diseases
- •PCI or bypass surgery within 30 days before randomization
- •History of contrast agent allergy
- •Baseline serum creatinine of >2.5 mg/dl or calculated creatinine clearance rate of <30 ml/min
- •Known bleeding diathesis or contraindications to dual antiplatelet treatment like active internal bleeding
- •Gastrointestinal and genitourinary bleeding of clinical significance within 6 weeks before randomization
- •History of stroke within 3 months
- •infectious diseases or fever
- •Life expectancy < 6 months
研究组 & 干预措施
Early invasive strategy
Patients undergo coronary angiography within 24 hours after admission and have percutaneous coronary intervention or coronary artery bypass grafting as soon as possible during the index hospitalization if appropriate.
干预措施: early coronary angiography (Procedure)
Deferred invasive strategy
Patients undergo coronary angiography and appropriate revascularization after at lest 72 hours from admission in the index hospitalization.
干预措施: delayed coronary angiography (Procedure)
结局指标
主要结局
Composite endpoint of all-cause mortality, non-lethal myocardial infarction, stroke and urgent revascularization
时间窗: 1 year
次要结局
- No reflow(during PCI)
- All-cause mortality(30 days after discharge, 6 months and 1 year after randomization)
- Non-lethal myocardial infarction(30 days after discharge, 6 months and 1 year after randomization)
- Severe recurrent ischemia(30 days after discharge, 6 months and 1 year after randomization)
- Stroke(30 days after discharge, 6 months and 1 year after randomization)
- Major bleeding(30 days after discharge, 6 months and 1 year after randomization)
研究者
Yuejin Yang
vice president of Fuwai Hospital
Chinese Academy of Medical Sciences, Fuwai Hospital
