Translational and Molecular Imaging Institute, Mount Sinai School of Medicine, New York, NY 10029, USA.
Am Heart J. 2011 Aug;162(2):214-221.e2. doi: 10.1016/j.ahj.2011.05.006.
dal-PLAQUE is a placebo-controlled multicenter study designed to assess the effect of dalcetrapib on imaging measures of plaque inflammation and plaque burden. dal-PLAQUE is a multimodality imaging study in the context of the large dal-HEART Program. Decreased high-density lipoprotein cholesterol is linked to increased risk of coronary heart disease (CHD). Dalcetrapib, a compound that increases high-density lipoprotein cholesterol by modulating cholesteryl ester transfer protein, is being studied to assess if it can reduce the progression of atherosclerotic disease and thereby decrease cardiovascular morbidity and mortality. Patients with CHD or CHD-risk equivalents were randomized to receive 600 mg dalcetrapib or placebo daily for 24 months, in addition to conventional lipid-lowering medication and other medications for cardiovascular risk factors. The primary outcomes are the effect of dalcetrapib on 18F-fluorodeoxyglucose positron emission tomography target-to-background ratio after 6 months and magnetic resonance imaging (MRI) plaque burden (wall area, wall thickness, total vessel area, and wall area/total vessel area ratio) after 12 months. Secondary objectives include positron emission tomography target-to-background ratio at 3 months and MRI plaque burden at 6 and 24 months; plaque composition at 6, 12, and 24 months; and aortic compliance at 6 months. A tertiary objective is to examine the dynamic contrast-enhanced MRI parameters of plaque neovascularization. In total, 189 subjects entered screening, and 130 were randomized. dal-PLAQUE will provide important information on the effects of dalcetrapib on markers of inflammation and atherosclerotic plaque burden and, thereby, on the safety of cholesteryl ester transfer protein modulation with dalcetrapib. Results are expected in 2011.
dal-PLAQUE 是一项安慰剂对照、多中心研究，旨在评估 dalcetrapib 对斑块炎症和斑块负担的影像学指标的影响。dal-PLAQUE 是 dal-HEART 大型计划背景下的一项多模态影像学研究。高密度脂蛋白胆固醇降低与冠心病（CHD）风险增加有关。Dalcetrapib 是一种通过调节胆固醇酯转移蛋白来增加高密度脂蛋白胆固醇的化合物，正在进行研究以评估其是否可以减缓动脉粥样硬化疾病的进展，从而降低心血管发病率和死亡率。CHD 或 CHD 风险等效患者被随机分为接受 600 毫克 dalcetrapib 或安慰剂，每日一次，持续 24 个月，同时使用常规降脂药物和其他心血管危险因素药物。主要结局是 dalcetrapib 对 6 个月后 18F-氟脱氧葡萄糖正电子发射断层扫描靶与背景比的影响，以及 12 个月后磁共振成像（MRI）斑块负担（壁面积、壁厚度、总血管面积和壁面积/总血管面积比）的影响。次要目标包括 3 个月时的正电子发射断层扫描靶与背景比和 6 个月和 24 个月时的 MRI 斑块负担；6、12 和 24 个月时的斑块成分；以及 6 个月时的主动脉顺应性。三级目标是检查斑块新生血管化的动态对比增强 MRI 参数。共有 189 名受试者进入筛选，130 名被随机分组。dal-PLAQUE 将提供有关 dalcetrapib 对炎症标志物和动脉粥样硬化斑块负担的影响的重要信息，从而为 dalcetrapib 调节胆固醇酯转移蛋白的安全性提供信息。结果预计在 2011 年公布。
