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临床试验/NCT00138034
NCT00138034已完成4 期

A Multicenter Randomized Trial in the Prevention of Reocclusion Following Successful Thrombolysis for Suspected Acute Myocardial Infarction: An Invasive Versus a Conservative Strategy

Heartcenter, University Medical Center St. Radboud2 个研究点 分布在 1 个国家目标入组 49 人开始时间: 2005年1月1日最近更新:
适应症

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
49
试验地点
2
主要终点
6-month Reocclusion

研究概览

简要总结

Reocclusion of the infarct artery is observed in about 30% of patients within three months after successful thrombolysis for acute myocardial infarction (MI). Reocclusion is associated with an increased risk of death, reinfarction and the need for revascularization. Even in the absence of clinical reinfarction, reocclusion results in impaired left ventricular (LV) recovery, leaving patients at increased risk of developing heart failure in the long-term. Prevention of reocclusion is therefore warranted. In previous trials, severity of the infarct related stenosis was the only independent predictor of reocclusion. With a lack of clinical predictors of reocclusion, many cardiologists therefore empirically favor routine revascularization after successful thrombolysis.

The APRICOT-3 will be the first randomized trial in the current era of improved angioplasty techniques to study the question of whether a routine invasive strategy after successful thrombolysis can reduce the incidence of reocclusion and subsequently improve clinical outcome and LV-function. After successful thrombolysis, patients will be randomized to either a routine invasive strategy or an ischemia-guided strategy. The investigators expect to demonstrate a lower reocclusion rate at the 6-month follow-up angiography (primary endpoint) and fewer associated events (death, reinfarction, revascularization, admissions for heart failure) in the routine invasive arm. In search of non-invasive parameters predictive of reocclusion, laboratory analysis of several coagulation and inflammatory markers will be performed. Finally, pooled analysis of all 3 APRICOT trials will focus on the identification of clinical predictors of reocclusion that can easily be obtained by history and physical examination.

详细描述

Randomized controlled study of elective percutaneous coronary intervention (PCI) of an open culprit lesion after fibrinolysis for ST-elevation myocardial infarction (STEMI)

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

性别
All
接受健康志愿者

入选标准

  • TIMI-3 in infarct-related artery with a stentable lesion with 72 hours of thrombolysis for ST-elevation myocardial infarction

排除标准

  • Use of oral anticoagulants.
  • Known intolerance to aspirin or clopidogrel.
  • Bypass graft as infarct-related artery.
  • Previously dilated infarct related artery.
  • Significant left main stenosis.
  • Unidentifiable culprit stenosis.

结局指标

主要结局

6-month Reocclusion

时间窗: 6 months

Less than TIMI (Thrombolysis In Myocardial Infarction) -3 flow of the infarct related coronary artery assessed at follow-up angiography

次要结局

  • Composite of Death, Reinfarction, Stroke and Revascularization at the Time of Follow-up Angiography(6 months)

研究者

发起方
Heartcenter, University Medical Center St. Radboud
申办方类型
Other
责任方
Principal Investigator
主要研究者

Prof. Dr. F.W.A. Verheugt

Professor of Cardiology

Heartcenter, University Medical Center St. Radboud

研究点 (2)

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