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Trial NCT00000500

Resource URI: http://static.linkedct.org/resource/trials/NCT00000500
PropertyValue
linkedct:brief_title Physicians' Health Study
linkedct:condition <http://static.linkedct.org/resource/condition/2312>
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 Male physicians, ages 40 to 84. No history of stroke, myocardial infarction, cancer, or renal disease. No contraindications to aspirin or beta-carotene. No current usage of aspirin or Vitamin A tables greater than once per week.
linkedct:description BACKGROUND: Thrombosis plays a major role in the late stages of coronary occlusion. Platelet aggregation is a large component in the formation of arterial thrombi. In pharmacologic studies, aspirin has been shown to inhibit platelet aggregation and, therefore, might be expected to prevent coronary occlusion. These effects are apparent in the dose range of l00-l000 mg/day, and may be most evident at l60 milligrams daily. Higher doses seem to be no more effective in either inhibition of platelet agreeability or prolonged bleeding time. Although an early case-control study by Jick and Miettinen showed a large benefit, most observational studies had shown a cardiovascular benefit of about 20 percent. Conclusive data could only result from a randomized trial with a large sample size. DESIGN NARRATIVE: Randomized, double-blind, fixed sample. Participants were randomized into one of four treatment groups: one 325 milligram aspirin tablet every other day, alternating with one 30 milligram capsule of beta-carotene; one aspirin every other day, alternating with one capsule of beta-carotene placebo; one aspirin placebo tablet every other day, alternating with one capsule of beta-carotene; and one aspirin placebo tablet every other day, alternating with one capsule of beta-carotene placebo. Major endpoints for the cardiovascular component of the study were cardiovascular mortality, total mortality, and coronary events.
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 84 Years
linkedct:eligibility_minimum_age 40 Years
linkedct:enrollment 0 (xsd:int)
linkedct:firstreceived_date October 27, 1999
linkedct:id NCT00000500
rdfs:label Trial NCT00000500
linkedct:lastchanged_date June 23, 2005
linkedct:lead_sponsor_agency National Heart, Lung, and Blood Institute (NHLBI)
linkedct:nct_id NCT00000500
linkedct:number_of_arms 0 (xsd:int)
linkedct:number_of_groups 0 (xsd:int)
linkedct:org_study_id 19
linkedct:overall_status Completed
linkedct:oversight <http://static.linkedct.org/resource/oversight/2918>
foaf:page <http://clinicaltrials.gov/show/NCT00000500>
linkedct:phase Phase 3
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linkedct:reference <http://static.linkedct.org/resource/reference/38089>
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linkedct:reference <http://static.linkedct.org/resource/reference/9451>
linkedct:source National Heart, Lung, and Blood Institute (NHLBI)
linkedct:start_date September 1981
linkedct:study_design Prevention, Randomized, Double-Blind
linkedct:study_type Interventional
linkedct:summary To assess the effect on cardiovascular mortality of alternate-day consumption of 325 milligrams of aspirin and, secondarily, the effect on cancer incidence of alternate-day consumption of 50 milligrams of beta-carotene.
rdf:type linkedct:trials
linkedct:verification_date May 2005