Cardiovascular computed tomographic assessment of the effect of combination lipoprotein therapy on coronary arterial plaque: rationale and design of the AFRICA (Atorvastatin plus Fenofibric acid in the Reduction of Intermediate Coronary Atherosclerosis) study.
Whether combination lipoprotein therapy targeting apolipoprotein B (apoB)- and apoA-containing lipoprotein particles and triglycerides (TGs) in low-risk, asymptomatic subjects with coronary atherosclerosis alters the natural progression of plaques is unknown. This study was designed to compare the progression of coronary atherosclerosis in asymptomatic, low-risk subjects without previously known coronary artery disease but with the presence of plaque on a combination of atorvastatin 40 mg plus fenofibric acid 135 mg daily for 18 months, using cardiovascular computed tomography (CCT). This is an investigator-initiated, single-center, prospective, double-blind, randomized, placebo-controlled, parallel-arm study. Asymptomatic subjects at low risk of cardiovascular events defined as <10% 10-year risk based on the Framingham Risk Score will be recruited, if they do not qualify for lipoprotein-lowering therapy based on the National Cholesterol Education Panel Adult Treatment Panel III guidelines. Subjects will qualify based on lipid parameters if their low-density lipoprotein cholesterol is >/=100 mg/dL and <190 mg/dL, TGs are >150 mg/dL, and the TGs/high-density lipoprotein cholesterol ratio is >3.5. Patients must have nonobstructive plaque based on CCT. Randomization will be 1:1 to either a combination of atorvastatin 40 mg plus fenofibric acid 135 mg daily or placebo for 18 months. Patients will undergo CCT at baseline and at the end of the treatment period. The primary end point will be the between-group difference in percent atheroma volume. Ultimately, this study can guide physicians about the use of a statin-fibric acid derivative combination in asymptomatic, low-risk persons with atherosclerosis.
Voros
Szilard
S
Piedmont Heart Institute, 1968 Peachtree Road, NW, Atlanta, GA 30309, USA. szilard.voros@piedmont.org
Joshi
Parag H
PH
Vazquez
Gustavo
G
Roth
Gina
G
Murrieta
Laura
L
Rinehart
Sarah
S
Qian
Zhen
Z
Miller
Joseph
J
D000069059:Atorvastatin; D015415:Biomarkers / Q000097:blood; D017023:Coronary Angiography / Q000379:methods*; D003324:Coronary Artery Disease / Q000097:blood / Q000000981:diagnostic imaging* / Q000188:drug therapy*; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D011345:Fenofibrate / Q000031:analogs & derivatives* / Q000627:therapeutic use; D005845:Georgia; D006538:Heptanoic Acids / Q000627:therapeutic use*; D006801:Humans; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors / Q000627:therapeutic use*; D000960:Hypolipidemic Agents / Q000627:therapeutic use*; D008055:Lipids / Q000097:blood; D011446:Prospective Studies; D011758:Pyrroles / Q000627:therapeutic use*; D012107:Research Design; D014057:Tomography, X-Ray Computed; D016896:Treatment Outcome
D015415:Biomarkers; D006538:Heptanoic Acids; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors; D000960:Hypolipidemic Agents; D008055:Lipids; D011758:Pyrroles; D000069059:Atorvastatin; C006012:fenofibric acid; D011345:Fenofibrate