中等强度他汀类药物加依折麦布与其他药物的比较高强度他汀类药物用于稳定冠状动脉斑块
中等强度他汀类药物联合依折麦布联合疗法与高强度他汀类药物单一疗法对冠状动脉斑块稳定性的比较
This study is a prospective, multicenter, randomized clinical trial aimed at comparing the effects of moderate-intensity statin plus ezetimibe combination therapy versus high-intensity statin monotherapy on coronary plaque stabilization. Using advanced imaging techniques such as near-infrared spectroscopy-intravascular ultrasound (NIRS-IVUS), the trial evaluates whether the combination therapy is non-inferior to monotherapy in stabilizing coronary plaques over 52 weeks. The primary endpoint is the change in percent atheroma volume (PAV) from baseline to week 52, assessed by grayscale IVUS. Secondary outcomes include changes in lipid core burden, inflammatory markers, and clinical events like myocardial infarction and ischemic stroke. Seven hospitals participated in the study. A total of 410 participants were enrolled at six sites; no participants were enrolled at Inje University Ilsan Paik Hospital. Follow-up is ongoing.
研究概览
研究类型
注册 (实际的)
阶段
- 第四阶段
联系人和位置
学习地点
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Goyang、韩国、10380
- Inje University Ilsan Paik Hospital
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Seoul、韩国、05278
- Kyung Hee University Hospital at Gangdong
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Seoul、韩国、02447
- Kyung Hee University Hospital
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Seoul、韩国、06973
- Chung-Ang University Hospital
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Seoul、韩国、04763
- Hanyang University Hospital
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Suwon、韩国、16499
- Ajou University Hospital
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Seoul
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Seoul、Seoul、韩国、02841
- Korea University Anam Hospital
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
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Adult men and women aged 18 years or older.
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Patients with coronary artery disease undergoing a coronary intervention procedure using intravascular imaging.
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At least one major native coronary artery ("target vessel") meeting all the following criteria for intracoronary imaging immediately following a qualifying PCI procedure:
- Angiographic evidence of coronary artery stenosis ≥30% by angiographic visual estimation.
- Target vessel is accessible to the imaging catheter and suitable for intracoronary imaging in the proximal 50 mm segment.
- Target vessel is not a bypass graft (saphenous vein or arterial) or a bypassed graft vessel.
- Target vessel has not undergone PCI within the target segment.
- Target vessel is not a candidate for PCI at the time of the procedure or for 6 months thereafter (per investigator's judgment).
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Patients who have provided written informed consent to participate in the study.
Exclusion Criteria:
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Left main stem lesion: Left main coronary artery stenosis ≥50% by coronary angiographic visual estimation.
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History of coronary artery bypass graft surgery (CABG).
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Unstable clinical condition (hemodynamic or electrical instability).
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Severe coronary artery calcification or tortuosity interfering with IVUS, NIRS, or evaluation.
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Uncontrolled cardiac arrhythmia (recurrent and symptomatic ventricular tachycardia or atrial fibrillation with rapid ventricular response) not controlled by medication within 3 months prior to screening.
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Active liver disease or liver dysfunction.
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Severe renal dysfunction (eGFR <30 mL/min/1.73m²)
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Known allergy to contrast media, heparin, aspirin, ticagrelor, or prasugrel.
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Active infection or major hematologic, metabolic, or endocrine dysfunction as determined by the investigator.
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Planned surgery within 12 months.
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Currently enrolled in another randomized device study or a drug study involving lipid-lowering therapy.
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Estimated life expectancy of less than 2 years.
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Women of childbearing potential (under 50 years of age) who:
- Had their last menstrual period within the last 12 months.
- Have not had tubal ligation, oophorectomy, or hysterectomy.
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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有源比较器:High Intensity Statin monotherapy
Rosuvastatin 20 mg once daily |
Rosuvastatin 20mg once daily |
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实验性的:Combination therapy
Rosuvastatin 10mg plus Ezetimibe 10mg fixed dose single-pill combination |
Rosuvastatin 10mg + Ezetimibe 10mg |
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change in percent atheroma volume (PAV) from baseline to week 52, assessed by gray-scale IVUS
大体时间:52 weeks
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Percent atheroma volume (PAV) is calculated within matched coronary-artery regions of interest as 100 × Σ(EEM CSA - lumen CSA)/Σ(EEM CSA), where EEM CSA is the external elastic membrane cross-sectional area and lumen CSA is the lumen cross-sectional area. Change in PAV between baseline and week 52 is assessed by gray-scale IVUS. |
52 weeks
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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从基线到第 52 周,通过 NIRS 测量的 4 毫米箱内最大 LCBI 的变化 (maxLCBI4mm)
大体时间:52周
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52周
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IVUS 测量的校正总动脉粥样硬化斑块体积 (NTAV) 从基线到第 52 周的变化
大体时间:52周
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52周
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从基线到第 52 周的所有死亡
大体时间:52周
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52周
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从基线到第 52 周的心脏相关死亡
大体时间:52周
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52周
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从基线到第 52 周的非致命性心肌梗死
大体时间:52周
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52周
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从基线到第 52 周的缺血性冠状动脉血运重建
大体时间:52周
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52周
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从基线到第 52 周的缺血性中风/TIA
大体时间:52周
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52周
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从基线到第 52 周的新发糖尿病发生率
大体时间:52周
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52周
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从基线到第 52 周他汀类药物相关肌肉综合征 (SAMS) 的发生率
大体时间:52周
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52周
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从基线到 52 周的白内障发病率
大体时间:52周
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52周
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HsCRP 从基线到 52 周的变化以及与斑块进展/消退指数的关联
大体时间:52周
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52周
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HsTnT 从基线到 52 周的变化以及与斑块进展/消退指数的关联
大体时间:52周
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52周
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NT-pro-BNP 从基线到 52 周的变化以及与斑块进展/消退指数的关联
大体时间:52周
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52周
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Change from baseline to week 52 in total lipid core burden index measured by NIRS (LCBItotal)
大体时间:52 weeks
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52 weeks
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Adherence from baseline to week 52 (80% or greater)
大体时间:52 weeks
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Proportion of patients achieving ≥80% adherence to prescribed medication from baseline to week 52 |
52 weeks
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Changes in LDL-cholesterol from baseline to 52 weeks and associations with plaque progression/regression indices
大体时间:52 weeks
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LDL-cholesterol levels measured in mg/dL. Blood samples will be collected at baseline and after 52 weeks. |
52 weeks
|
合作者和调查者
出版物和有用的链接
一般刊物
- Sattar N, Preiss D, Murray HM, Welsh P, Buckley BM, de Craen AJ, Seshasai SR, McMurray JJ, Freeman DJ, Jukema JW, Macfarlane PW, Packard CJ, Stott DJ, Westendorp RG, Shepherd J, Davis BR, Pressel SL, Marchioli R, Marfisi RM, Maggioni AP, Tavazzi L, Tognoni G, Kjekshus J, Pedersen TR, Cook TJ, Gotto AM, Clearfield MB, Downs JR, Nakamura H, Ohashi Y, Mizuno K, Ray KK, Ford I. Statins and risk of incident diabetes: a collaborative meta-analysis of randomised statin trials. Lancet. 2010 Feb 27;375(9716):735-42. doi: 10.1016/S0140-6736(09)61965-6. Epub 2010 Feb 16.
- Preiss D, Seshasai SR, Welsh P, Murphy SA, Ho JE, Waters DD, DeMicco DA, Barter P, Cannon CP, Sabatine MS, Braunwald E, Kastelein JJ, de Lemos JA, Blazing MA, Pedersen TR, Tikkanen MJ, Sattar N, Ray KK. Risk of incident diabetes with intensive-dose compared with moderate-dose statin therapy: a meta-analysis. JAMA. 2011 Jun 22;305(24):2556-64. doi: 10.1001/jama.2011.860.
- Maron DJ, Hochman JS, Reynolds HR, Bangalore S, O'Brien SM, Boden WE, Chaitman BR, Senior R, Lopez-Sendon J, Alexander KP, Lopes RD, Shaw LJ, Berger JS, Newman JD, Sidhu MS, Goodman SG, Ruzyllo W, Gosselin G, Maggioni AP, White HD, Bhargava B, Min JK, Mancini GBJ, Berman DS, Picard MH, Kwong RY, Ali ZA, Mark DB, Spertus JA, Krishnan MN, Elghamaz A, Moorthy N, Hueb WA, Demkow M, Mavromatis K, Bockeria O, Peteiro J, Miller TD, Szwed H, Doerr R, Keltai M, Selvanayagam JB, Steg PG, Held C, Kohsaka S, Mavromichalis S, Kirby R, Jeffries NO, Harrell FE Jr, Rockhold FW, Broderick S, Ferguson TB Jr, Williams DO, Harrington RA, Stone GW, Rosenberg Y; ISCHEMIA Research Group. Initial Invasive or Conservative Strategy for Stable Coronary Disease. N Engl J Med. 2020 Apr 9;382(15):1395-1407. doi: 10.1056/NEJMoa1915922. Epub 2020 Mar 30.
- Raber L, Ueki Y, Otsuka T, Losdat S, Haner JD, Lonborg J, Fahrni G, Iglesias JF, van Geuns RJ, Ondracek AS, Radu Juul Jensen MD, Zanchin C, Stortecky S, Spirk D, Siontis GCM, Saleh L, Matter CM, Daemen J, Mach F, Heg D, Windecker S, Engstrom T, Lang IM, Koskinas KC; PACMAN-AMI collaborators. Effect of Alirocumab Added to High-Intensity Statin Therapy on Coronary Atherosclerosis in Patients With Acute Myocardial Infarction: The PACMAN-AMI Randomized Clinical Trial. JAMA. 2022 May 10;327(18):1771-1781. doi: 10.1001/jama.2022.5218.
- Davis JW, Weller SC. Intensity of statin therapy and muscle symptoms: a network meta-analysis of 153 000 patients. BMJ Open. 2021 Jun 15;11(6):e043714. doi: 10.1136/bmjopen-2020-043714.
- Kim BK, Hong SJ, Lee YJ, Hong SJ, Yun KH, Hong BK, Heo JH, Rha SW, Cho YH, Lee SJ, Ahn CM, Kim JS, Ko YG, Choi D, Jang Y, Hong MK; RACING investigators. Long-term efficacy and safety of moderate-intensity statin with ezetimibe combination therapy versus high-intensity statin monotherapy in patients with atherosclerotic cardiovascular disease (RACING): a randomised, open-label, non-inferiority trial. Lancet. 2022 Jul 30;400(10349):380-390. doi: 10.1016/S0140-6736(22)00916-3. Epub 2022 Jul 18.
- Park SJ, Ahn JM, Kang DY, Yun SC, Ahn YK, Kim WJ, Nam CW, Jeong JO, Chae IH, Shiomi H, Kao HL, Hahn JY, Her SH, Lee BK, Ahn TH, Chang KY, Chae JK, Smyth D, Mintz GS, Stone GW, Park DW; PREVENT Investigators. Preventive percutaneous coronary intervention versus optimal medical therapy alone for the treatment of vulnerable atherosclerotic coronary plaques (PREVENT): a multicentre, open-label, randomised controlled trial. Lancet. 2024 May 4;403(10438):1753-1765. doi: 10.1016/S0140-6736(24)00413-6. Epub 2024 Apr 8.
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- STOP-PLAQUE
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
在美国制造并从美国出口的产品
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