Cardiovascular Diseases Clinical Trial
To determine whether warfarin or lovastatin alone or in combination retarded the progression of atherosclerotic plaques in the carotid arteries of high risk individuals with asymptomatic carotid stenosis. Also, to determine if a full scale trial was feasible.
BACKGROUND:
At the present time, atherosclerosis of the major extracranial arteries to the brain is
considered the cause of most strokes. Early intervention and stroke prevention utilized
anti-coagulants such as coumadin and heparin. Results were largely equivocal due to the
diverse nature of the underlying pathogenesis and due to problems that offset potential
benefit. Emphasis gradually switched to aspirin and to other platelet anti-aggregant drugs
because of mounting evidence that micro-emboli were a major element in transient ischemic
attacks. Several studies have examined the potential benefit of aspirin in stroke
prevention. The exact dose of aspirin that was maximally beneficial with minimal side
effects was not completely established. There was evidence that low dose aspirin was as
effective as higher doses. The American College of Chest Physicians (ACCP) made
recommendations that if aspirin were issued as a primary anti-thrombotic agent, the dose
should be 325 mg daily, except in patients with cerebrovascular disease in whom the lowest
beneficial dose appeared to be one gram per day. The ACCP also pointed out that the risk of
bleeding was substantially greater in patients with ischemic cerebrovascular disease and
venous thromboembolism than in other high risk groups requiring anticoagulation. It advised
that anticoagulant therapy was not needed, but that aspirin might be given at 325 mg per
day.
Lovastatin is a fungal metabolite that inhibits 3-hydroxy, 3-methyl glutaryl coenzyme A
reductase, the rate-limiting enzyme of cholesterol biosynthesis in human cells including the
liver. Inhibition of this pathway causes the cells to increase their low density lipoprotein
receptor numbers to compensate, causing a reduction in circulating low density lipoprotein
levels with a consequent drop in circulating plasma cholesterol levels. The drug also raises
high density lipoprotein levels significantly. A favorable outcome of the trial will have
major public health implications for the prevention and control of atherosclerosis and its
complications.
DESIGN NARRATIVE:
Randomized, double-blind, factorial design. In this multicenter study, patients were
assigned to one of four drug combination groups: active lovastatin/active warfarin, active
lovastatin/warfarin placebo, lovastatin placebo/active warfarin, and lovastatin
placebo/warfarin placebo. Daily aspirin was recommended for everyone. Ultrasound was
performed for screening, at baseline and semiannually thereafter. Lipid profiles were
obtained at screening, at baseline, monthly for the first three months, at six months, and
annually thereafter, with beta quantification at baseline. Recruitment began in the tenth
month of the trial and continued for one year, ending in September 1990. Treatment continued
through the 51st month. Average treatment period was 2.7 years. Subjects were offered a
dietary regimen for three months prior to receiving any drug therapy. Only those individuals
whose lipid levels did not fall below a certain point continued in dietary intervention. The
primary outcome measure was the three year change in mean maximum intimal-medial thickness
(IMT) in twelve walls of the carotid arteries. Secondary outcomes included change in single
maximum IMT and incidence of major cardiovascular events.
In 1995, an R03 was awarded to Mark Espeland to extend analyses of the carotid B-mode
ultrasound data through August, 1998.
The study completion date listed in this record was obtained from the "End Date" entered in
the Protocol Registration and Results System (PRS) record.
;
Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Prevention
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