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一项关于大剂量他汀类药物对成功修复缩窄后成年人心血管风险影响的试验的原理和设计。

Rationale and design of a trial on the effect of high dose statins on cardiovascular risk in adults after successful coarctation repair.

机构信息

Department of Cardiology, Academic Medical Centre, Amsterdam, The Netherlands.

出版信息

Contemp Clin Trials. 2012 Mar;33(2):410-6. doi: 10.1016/j.cct.2011.11.011. Epub 2011 Nov 13.

DOI:10.1016/j.cct.2011.11.011
PMID:22108629
Abstract

BACKGROUND

HMG-coA-reductase-inhibitors (statins) have been proven to reduce atherosclerosis progression as observed by carotid intima-media thickness in patients with known coronary heart disease, independent of lipid lowering. Cardiovascular complications are common in patients after successful coarctation repair. The effect of statins on cardiovascular risk in adults after successful coarctation repair has not yet been established.

METHODS

We designed a multicentre, prospective, randomised, open label trial to evaluate the effect of the HMGcoA-reductase-inhibitor (Atorvastatin) on atherosclerotic progression in adult post-coarctectomy patients. The primary endpoint in this study is the carotid intima-media thickness as measured by Bmode ultrasonography of the carotid arteries.

CONCLUSION

This large prospective, randomised, open label trial will establish the effect of HMG-coA-reductase inhibitors (Atorvastatin) on cardiovascular risk in adult patients after successful coarctation repair.

摘要

背景

HMG-CoA 还原酶抑制剂(他汀类药物)已被证明可降低已知冠心病患者颈动脉内膜中层厚度观察到的动脉粥样硬化进展,而与降低血脂无关。心血管并发症在成功修复缩窄后的患者中很常见。他汀类药物对成功修复缩窄后成年人心血管风险的影响尚未确定。

方法

我们设计了一项多中心、前瞻性、随机、开放标签试验,以评估 HMGCoA 还原酶抑制剂(阿托伐他汀)对成人缩窄后动脉粥样硬化进展的影响。本研究的主要终点是通过颈动脉 B 型超声测量颈动脉内膜中层厚度。

结论

这项大型前瞻性、随机、开放标签试验将确定 HMG-CoA 还原酶抑制剂(阿托伐他汀)对成功修复缩窄后成年患者心血管风险的影响。

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Circulation. 2020 Aug 18;142(7):621-642. doi: 10.1161/CIRCULATIONAHA.120.046361. Epub 2020 Jun 17.
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Perioperative statin therapy for improving outcomes during and after noncardiac vascular surgery.围手术期他汀类药物治疗以改善非心脏血管手术期间及术后的结局。
Cochrane Database Syst Rev. 2013 Jul 3;2013(7):CD009971. doi: 10.1002/14651858.CD009971.pub2.