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ACAPS
Asymptomatic Carotid Artery Plaque Study
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Author(s) |
(a) The ACAPS group
(b) Furberg CD, Adams HP Jr, Applegate WB, Byington RP, Espeland MA, Hartwell T, Hunninghake DB, Lefkowitz DS, Probstfield J, Riley WA, Young B
(c) Probstfield J, Margitic SE, Byington RP, Espeland MA, Furberg CD
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Title(s) |
(a) Rationale and design for the Asymptomatic Carotid Artery Plaque Study (ACAPS)
(b) Coronary heart disease/myocardial infarction: Effect of lovastatin on early carotid atherosclerosis and cardiovascular events
(c) Results of the primary outcome measure and clinical events from the Asymptomatic Carotid Artery Progression Study
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Reference(s) |
(a) Control Clin Trials 1992;13:293-314
(b) Circulation 1994;90:1679-87
(c) Am J Cardiol 1995;76:47C-53C
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Disease |
Carotid atherosclerosis
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Purpose |
To assess the effects of lovastatin and warfarin on carotid atherosclerosis progression in asymptomatic high-risk individuals. Secondary, to assess the effect of the treatments on the incidence of major atherosclerotic events
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Study design |
Randomised, double-blind, placebo-controlled, factorial
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Follow-up |
3 years
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Patients |
919 subjects (48% women), aged 40-79 years (mean 62 years), with moderately elevated serum LDL cholesterol (≥ 130 and ≤ 189 mg/dl) and a thickening of the arterial wall (≥ 1.5 and < 3.5 mm) without previous MI, severe angina, stroke, or TIA
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Treatment regimen |
Lovastatin, 10-40 mg/day, and/or warfarin, 1 mg/day, or placebo
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Concomitant therapy |
Aspirin, 81 mg/day
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Results |
Mean LDL fell by 28% at 6 months in the lovastatin group (p < 0.0001 vs placebo) and remained stable throughout the follow-up. Regression of early atherosclerosis was seen after 12 months in the lovastatin-only group, compared to the placebo group (p < 0.001). No progression occurred in the lovastatin-placebo groups. A negative interaction (p = 0.04) was observed in the group receiving both lovastatin and warfarin. The incidence of major cardiovascular events and all-cause mortality was significantly (p < 0.05) lower in the lovastatin group compared to the placebo group
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