TY - JOUR
T1 - Rationale and design of dal-PLAQUE
T2 - 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
AU - Fayad, Zahi A.
AU - Mani, Venkatesh
AU - Woodward, Mark
AU - Kallend, David
AU - Bansilal, Sameer
AU - Pozza, Joseph
AU - Burgess, Tracy
AU - Fuster, Valentin
AU - Rudd, James H.F.
AU - Tawakol, Ahmed
AU - Farkouh, Michael E.
N1 - Funding Information:
This study was funded by F. Hoffmann–La Roche Ltd. Editorial assistance was provided by Prime Healthcare during the preparation of this report and funded by F. Hoffmann–La Roche Ltd. Z.A.F. discloses that he has received research grants from Roche, GlaxoSmithKline, Merck, VBL Therapeutics, Novartis, Bristol-Myers Squibb, and Via Pharmaceuticals and honoraria from Roche. M.E.F., J.H.F.R., A.T., and M.W. disclose that they have received honoraria from Roche. J.H.F.R. is part-supported by the National Institute for Health Research Cambridge Biomedical Research Centre. T.B. and J.P. disclose that they are employees of Hoffmann–La Roche Inc, and D.K. is an employee of F. Hoffmann–La Roche Ltd. V.M., S.B., and V.F. indicate that they have nothing to disclose.
Funding Information:
This study was supported by Hoffmann–La Roche Inc.
PY - 2011/8
Y1 - 2011/8
N2 - 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.
AB - 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.
UR - http://www.scopus.com/inward/record.url?scp=80051609177&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=80051609177&partnerID=8YFLogxK
U2 - 10.1016/j.ahj.2011.05.006
DO - 10.1016/j.ahj.2011.05.006
M3 - Article
C2 - 21835280
AN - SCOPUS:80051609177
SN - 0002-8703
VL - 162
SP - 214-221.e2
JO - American heart journal
JF - American heart journal
IS - 2
ER -