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Trial NCT00000512

Resource URI: http://static.linkedct.org/resource/trials/NCT00000512
linkedct:brief_title Familial Atherosclerosis Treatment Study (FATS)
linkedct:condition <http://static.linkedct.org/resource/condition/2312>
linkedct:condition <http://static.linkedct.org/resource/condition/3361>
linkedct:condition <http://static.linkedct.org/resource/condition/3388>
linkedct:condition <http://static.linkedct.org/resource/condition/5702>
linkedct:condition <http://static.linkedct.org/resource/condition/8489>
linkedct:criteria Men ages 62 or younger, with elevated apolipoprotein B levels, coronary atherosclerosis, and a family history of coronary heart disease.
linkedct:description BACKGROUND: For several decades, clinical trials have addressed the question of whether treatment of hyperlipidemia reduces the risk of cardiovascular events. Substantial evidence supports the idea that cardiovascular benefits are related to the degree of reduction in low-density lipoprotein cholesterol level and perhaps to the degree of increase in the high-density lipoprotein cholesterol level. In these trials, changes in lipid levels have usually been small and the overall clinical benefits have been limited. The appearance in the 1980s of more effective treatments for hyperlipidemia, new arteriographic methods for assessing atherosclerosis, and new insights into atherogenesis permitted an objective investigation into whether the progression of atherosclerosis was retarded or reversed by lipid-lowering agents. The clinical trial was supported by a subproject within a program project grant. DESIGN NARRATIVE: Randomized, double-blind, placebo-controlled. Baseline arteriograms were performed and fasting lipid samples drawn before heparinization. Patients were stratified for age below 45 years, cigarette smoking within the previous month, and lipid patterns including familial hypercholesterolemia and triglyceride levels. Patients were given dietary counseling and randomly assigned to one of three treatments: lovastatin (20 mg twice a day) and colestipol (10 g three times a day); niacin (1 g four times a day) and colestipol (10 g three times a day): or conventional therapy with placebo (or colestipol if the LDL cholesterol level was elevated). The primary endpoint was a measure of change in the severity of disease in the proximal coronary arteries as measured by quantitative arteriography.
linkedct:download_date Information obtained from ClinicalTrials.gov on December 30, 2009
linkedct:eligibility_gender Male
linkedct:eligibility_healthy_volunteers No
linkedct:eligibility_maximum_age 62 Years
linkedct:eligibility_minimum_age 18 Years
linkedct:enrollment 0 (xsd:int)
linkedct:firstreceived_date October 27, 1999
linkedct:id NCT00000512
rdfs:label Trial NCT00000512
linkedct:lastchanged_date June 23, 2005
linkedct:lead_sponsor_agency National Heart, Lung, and Blood Institute (NHLBI)
linkedct:nct_id NCT00000512
linkedct:number_of_arms 0 (xsd:int)
linkedct:number_of_groups 0 (xsd:int)
linkedct:org_study_id 31
linkedct:overall_status Completed
linkedct:oversight <http://static.linkedct.org/resource/oversight/2918>
foaf:page <http://clinicaltrials.gov/show/NCT00000512>
linkedct:phase Phase 3
linkedct:reference <http://static.linkedct.org/resource/reference/38506>
linkedct:reference <http://static.linkedct.org/resource/reference/4269>
linkedct:reference <http://static.linkedct.org/resource/reference/44873>
linkedct:reference <http://static.linkedct.org/resource/reference/45770>
linkedct:reference <http://static.linkedct.org/resource/reference/47496>
linkedct:reference <http://static.linkedct.org/resource/reference/48082>
linkedct:source National Heart, Lung, and Blood Institute (NHLBI)
linkedct:start_date January 1984
linkedct:study_design Treatment, Randomized, Double-Blind, Placebo Control
linkedct:study_type Interventional
linkedct:summary To compare the effects of two intensive lipid-lowering regimens with conventional therapy on coronary atherosclerosis as assessed by arteriography.
rdf:type linkedct:trials
linkedct:verification_date January 2000