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Trial NCT00000469

Resource URI: http://static.linkedct.org/resource/trials/NCT00000469
linkedct:brief_title Asymptomatic Carotid Artery Plaque Study (ACAPS)
linkedct:condition <http://static.linkedct.org/resource/condition/13668>
linkedct:condition <http://static.linkedct.org/resource/condition/2312>
linkedct:condition <http://static.linkedct.org/resource/condition/2348>
linkedct:condition <http://static.linkedct.org/resource/condition/2444>
linkedct:condition <http://static.linkedct.org/resource/condition/2475>
linkedct:condition <http://static.linkedct.org/resource/condition/5702>
linkedct:criteria Men and women with early carotid atherosclerosis and moderately elevated LDL cholesterol between the 60th and 90th percentiles.
linkedct:description 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.
linkedct:download_date Information obtained from ClinicalTrials.gov on December 30, 2009
linkedct:eligibility_gender Both
linkedct:eligibility_healthy_volunteers No
linkedct:eligibility_maximum_age 79 Years
linkedct:eligibility_minimum_age 40 Years
linkedct:end_date August 1998
linkedct:enrollment 0 (xsd:int)
linkedct:firstreceived_date October 27, 1999
linkedct:id NCT00000469
rdfs:label Trial NCT00000469
linkedct:lastchanged_date June 23, 2005
linkedct:lead_sponsor_agency National Heart, Lung, and Blood Institute (NHLBI)
linkedct:nct_id NCT00000469
linkedct:number_of_arms 0 (xsd:int)
linkedct:number_of_groups 0 (xsd:int)
linkedct:org_study_id 58
linkedct:overall_official <http://static.linkedct.org/resource/overall_official/10777>
linkedct:overall_official <http://static.linkedct.org/resource/overall_official/38126>
linkedct:overall_status Completed
linkedct:oversight <http://static.linkedct.org/resource/oversight/2918>
foaf:page <http://clinicaltrials.gov/show/NCT00000469>
linkedct:phase Phase 2
linkedct:reference <http://static.linkedct.org/resource/reference/18811>
linkedct:reference <http://static.linkedct.org/resource/reference/21055>
linkedct:reference <http://static.linkedct.org/resource/reference/29440>
linkedct:reference <http://static.linkedct.org/resource/reference/44802>
linkedct:reference <http://static.linkedct.org/resource/reference/45176>
linkedct:reference <http://static.linkedct.org/resource/reference/45954>
linkedct:reference <http://static.linkedct.org/resource/reference/47335>
linkedct:reference <http://static.linkedct.org/resource/reference/4965>
linkedct:reference <http://static.linkedct.org/resource/reference/49666>
linkedct:reference <http://static.linkedct.org/resource/reference/50528>
linkedct:source National Heart, Lung, and Blood Institute (NHLBI)
linkedct:start_date May 1988
linkedct:study_design Prevention, Randomized, Double-Blind, Placebo Control
linkedct:study_type Interventional
linkedct:summary 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.
rdf:type linkedct:trials
linkedct:verification_date April 2000