Influence of Intensive Lipid-lowering Witgh Statin and Ezetimibe Prescription on Computed Tomography Derived Fractional Flow Reserve in Patients With Stable Chest Pain
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
- 否
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
Usual care: atorvastatin 40 mg
干预措施: High intensity lipid lowering (Drug)
Intensive lipid lowering
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
Bjarne Linde Nørgaard
Professor, MD, DMSc, PhD
Aarhus University Hospital
