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临床试验/NCT05368545
NCT05368545已完成不适用

Influence of Intensive Lipid-lowering Witgh Statin and Ezetimibe Prescription on Computed Tomography Derived Fractional Flow Reserve in Patients With Stable Chest Pain

Aarhus University Hospital1 个研究点 分布在 1 个国家目标入组 109 人开始时间: 2020年5月15日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
109
试验地点
1
主要终点
Changes in FFRct values

研究概览

简要总结

This study assess in patients with stable chest pain and coronary artery disease (CAD) determined by coronary CTA whether cholesterol lowering with regression of coronary adverse plaque characteristics is associated with recovery of impaired flow

详细描述

Multicenter, prospective study. 105 patients with stable chest pain, and moderate CAD, statin naive (and LDL cholesterol >2 mM), and at least one translesional FFRct value <0.81 are randomized (patients with significant CAD in the left main or other proximal segments are excluded from the study) to either "atorvastatin 40 mg daily" or "rosuvastatin 40 mg + ezetimibe 10 mg daily" treatment. Patients are followed for 18 months with 2 CT scans performed at 9 months and one at 18 months. At each 4 CT scans blinded corelab analyses of plaque characteristics and volumes as well as FFRct calculation (HeartFlow) are performed. The primary endpoint is changes in FFRct values from 0 to 18 months. Secondary endpoints are 1 changes in FFRct values from 0 to 9 months of follow-up, and changes in low density plaques volumes and number of lesions with positive remodeling over time relative to changes in LDL cholesterol.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

年龄范围
35 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age ≥35 y
  • Symptoms suggestive of stable CAD
  • No pre-CTA known CAD
  • At least one lesion with FFRct <0.81
  • Sinus rhythm
  • LDL cholesterol >2.0 mM
  • Statin use >2 months
  • Life expentancy < 3 years
  • Signed informed consent

排除标准

  • Known CAD
  • Poor CTA image quality inadequiate for FFRct analysis (determined by corelab)
  • Significant CAD in the left main or proximal coronary segments
  • Referral to invasive catheterization
  • Statin intolerance
  • Allergy to ionidated contrast
  • Pregnancy

研究组 & 干预措施

usual care lipid lowering

Active Comparator

Usual care: atorvastatin 40 mg

干预措施: High intensity lipid lowering (Drug)

Intensive lipid lowering

Experimental

Intensive: rosuvastatin 40 mg + ezetimibe 10 mg

干预措施: High intensity lipid lowering (Drug)

结局指标

主要结局

Changes in FFRct values

时间窗: 18 months

CT derived FFR

次要结局

  • Changes in FFRct values(9 months)
  • Changes in low density plaque volumes(0-9, and 0-18 months)

研究者

发起方
Aarhus University Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Bjarne Linde Nørgaard

Professor, MD, DMSc, PhD

Aarhus University Hospital

研究点 (1)

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