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临床试验/NCT01478984
NCT01478984Unknown3 期

Impact of One Stage Compared With Multistaged PCI Complete Revascularization on Clinical Outcome in Multivessel NSTEMI Patients. Smile Trial

Gennaro Sardella1 个研究点 分布在 1 个国家目标入组 247 人开始时间: 2011年10月1日最近更新:
适应症
干预措施

试验速览

阶段
3 期
入组人数
247
试验地点
1
主要终点
Major Adverese Cardiac and cerebral Events (MACCE)

研究概览

简要总结

Patients with NSTEMI and multivessel disease will be scheduled to undergo early invasive strategy (PCI within 72 hours) of de novo native coronary artery lesions were considered for recruitment into the study. Inclusion criteria are the following: diagnosis of NSTEMI according to current guidelines presenting with multivessel disease. We will exclude patients with cardiogenic shock at presentation (systolic blood pressure <90 mmHg despite drug therapy), left main coronary disease (>50% diameter stenosis), previous coronary artery bypass grafting (CABG) surgery, patients with Syntax Score >32 and candidated to by-pass surgery (10), severe valvular heart disease and unsuccessful procedures. Procedure success was defined as the achievement of an angiographic residual stenosis of less than 30% and a thrombolysis in myocardial infarction (TIMI) flow grade III after PCI.

Patients randomized to One-Stage group were completely revascularizated in one time PCI, whereas patients randomized to Multi-Staged group were completely revascularizated in more time PCI, during the same hospitalization. Patients received a clopidogrel loading dose of 600 mg before the PCI (for loading dose administered more than 6 h prior to procedure). Post-procedural antiplatelet regimen consisted of aspirin at 100 mg/day indefinitely and clopidogrel 75 mg/day for at least one month.

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 95 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •diagnosis of NSTEMI
  • •presenting with multivessel disease

排除标准

  • •patients with cardiogenic shock at presentation
  • •left main coronary disease (>50% diameter stenosis)
  • •previous coronary artery bypass grafting (CABG) surgery
  • •patients with Syntax Score >32
  • •candidated to by-pass surgery
  • •severe valvular heart disease
  • •unsuccessful procedures

研究组 & 干预措施

one staged PCI

Active Comparator

the patient randomized to this arms complete the myocardial revascularization in one stage PCI, the investigators treat all lesions.

干预措施: One-Stage group (Procedure)

multistaged PCI

Active Comparator

the patients randomized to this arms in the first stage the investigators treat only the culprit lesion and in second stage the investigators treat the other vessels

干预措施: Multi-Staged group (Procedure)

结局指标

主要结局

Major Adverese Cardiac and cerebral Events (MACCE)

时间窗: 30 days

Incidence of major adverse cardiac and cerebrovascular events (MACCE) defined as cardiac or non-cardiac death, inhospital death, re-infarction, re-hospitalisation for acute coronary syndrome, repeat coronary revascularization and stroke at 30 days, 6 months and 1 year.

MACCE

时间窗: 6 months

Incidence of major adverse cardiac and cerebrovascular events (MACCE) defined as cardiac or non-cardiac death, inhospital death, re-infarction, re-hospitalisation for acute coronary syndrome, repeat coronary revascularization and stroke at 30 days, 6 months and 1 year.

Major Adverese Cardiac and cerebral Events (MACCE)

时间窗: 12 months

Incidence of major adverse cardiac and cerebrovascular events (MACCE) defined as cardiac or non-cardiac death, inhospital death, re-infarction, re-hospitalisation for acute coronary syndrome, repeat coronary revascularization and stroke at 30 days, 6 months and 1 year.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Gennaro Sardella

Associate Professor in Cardiology

University of Roma La Sapienza

研究点 (1)

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