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临床试验/NCT01228227
NCT01228227已完成3 期

High Loading ROsuvastatin Pretreatment in Patients Undergoing Elective PCI to Reduce the Incidence of MyocArdial Periprocedural Necrosis : Comparison With Atorvastatin High Dose Reloading.

Gennaro Sardella1 个研究点 分布在 1 个国家目标入组 310 人开始时间: 2010年10月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
状态
已完成
入组人数
310
试验地点
1
主要终点
Myocardial enzymes arise

研究概览

简要总结

An increase in cardiac biomarkers has been shown to occur in 5% to 30% of patients after otherwise successful percutaneous coronary interventions (PCIs)(1) Apart from side-branch occlusion, intimal dissection and coronary spasm, a possible aetiology of myonecrosis after PCI might be distal embolization of atherogenic materials from plaque disruption,(2 )causing obstruction of blood flow at capillary level resulting in micro-infarction.(3,4 )Recent studies have suggested that pretreatment with Atorvastatin may be associated with a reduction in infarct size after elective PCI. (5-7 ). Actually the standard pretreatment in patients undergoing elective coronary-PCI and already treated with aspirin is clopidogrel loading dose administration before procedure.(8,9)The investigators compared a high (80mg) re-loading dose of Atorvastatin with a high loading dose of Rosuvastatin (40 mg) both administered within 24h before the procedure in reducing the rate of periprocedural MI. Therefore, the investigators will conduct a single center, prospective randomized study to assess whether a single, high (80mg) loading (within 24h)dose of Atorvastatin compared with a single loading dose of Rosuvastatin (20 mg) is effective in preventing elevation of biomarkers of MI after elective coronary stent implantation. We evaluate the incidence of MACCE(occurring of cardiac death, myocardial infarction (including periprocedural myonecrosis) and stroke at 30 days 6 and 12 month follow-up.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
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

入选标准

  • Patients with stable angina

排除标准

  • Baseline myocardial enzyme rise

研究组 & 干预措施

ROSUVASTATIN

Active Comparator

干预措施: ROSUVASTATIN 40 mg (Drug)

ATORVASTATIN

Experimental

干预措施: ATORVASTATIN 80 mg (Drug)

结局指标

主要结局

Myocardial enzymes arise

时间窗: 12- 24 hours

次要结局

  • MACCE(1-6-12 Months)

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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