Rationale and design of dal-PLAQUE: A study assessing efficacy and safety of dalcetrapib on progression or regression of atherosclerosis using magnetic resonance imaging and 18F-fluorodeoxyglucose positron emission tomography/computed tomography

被引：43

作者：

Fayad, Zahi A. ^{[1
,2
]}

Mani, Venkatesh

Woodward, Mark ^{[3
]}

Kallend, David ^{[5
]}

Bansilal, Sameer ^{[2
]}

Pozza, Joseph ^{[4
]}

Burgess, Tracy ^{[4
]}

Fuster, Valentin ^{[2
,6
]}

Rudd, James H. F. ^{[7
]}

Tawakol, Ahmed ^{[8
,9
]}

Farkouh, Michael E. ^{[2
,10
,11
]}

机构：

[1] Mt Sinai Sch Med, Dept Radiol, Translat & Mol Imaging Inst, New York, NY 10029 USA

[2] Mt Sinai Sch Med, Cardiovasc Inst, New York, NY 10029 USA

[3] Univ Sydney, George Inst, Sydney, NSW 2006, Australia

[4] F Hoffmann La Roche Inc, Nutley, NJ USA

[5] F Hoffmann La Roche Ltd, Basel, Switzerland

[6] Ctr Nacl Invest Cardiovasc, Madrid, Spain

[7] Univ Cambridge, Div Cardiovasc Med, Cambridge CB2 1TN, England

[8] Harvard Univ, Sch Med, Boston, MA USA

[9] Massachusetts Gen Hosp, Boston, MA 02114 USA

[10] Peter Munk Cardiac Ctr, Toronto, ON, Canada

[11] Li Ki Shing Knowledge Inst, Toronto, ON, Canada

来源：

AMERICAN HEART JOURNAL | 2011年 / 162卷 / 02期

关键词：

DENSITY-LIPOPROTEIN CHOLESTEROL; RAPID EXTENDED COVERAGE; INTIMA-MEDIA THICKNESS; HIGH-RESOLUTION; CAROTID PLAQUE; VASCULAR INFLAMMATION; CETP INHIBITION; CORONARY ATHEROSCLEROSIS; BLOOD-PRESSURE; HIGH-RISK;

D O I：

10.1016/j.ahj.2011.05.006

中图分类号：

R5 [内科学];

学科分类号：

1002 ; 100201 ;

摘要：

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. (Am Heart J 2011;162:214-221.e2.)

引用

页码：214 / U29

页数：10

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