Women's Health Study (WHS): A Randomized Trial of Low-dose Aspirin and Vitamin E in the Primary Prevention of Cardiovascular Disease and Cancer

Launched by BRIGHAM AND WOMEN'S HOSPITAL · Oct 27, 1999

Nctid: NCT00000479

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Ethnic distribution of factor V Leiden in 4047 men and women. Implications for venous thromboembolism screening. JAMA. 1997 Apr 23-30;277(16):1305-7."}, {"pmid"=>"9727541", "type"=>"BACKGROUND", "citation"=>"Ridker PM, Buring JE, Shih J, Matias M, Hennekens CH. Prospective study of C-reactive protein and the risk of future cardiovascular events among apparently healthy women. Circulation. 1998 Aug 25;98(8):731-3. doi: 10.1161/01.cir.98.8.731."}, {"pmid"=>"10449692", "type"=>"BACKGROUND", "citation"=>"Ridker PM, Hennekens CH, Rifai N, Buring JE, Manson JE. Hormone replacement therapy and increased plasma concentration of C-reactive protein. Circulation. 1999 Aug 17;100(7):713-6. doi: 10.1161/01.cir.100.7.713."}, {"pmid"=>"10601381", "type"=>"BACKGROUND", "citation"=>"Lee IM, Cook NR, Manson JE, Buring JE, Hennekens CH. Beta-carotene supplementation and incidence of cancer and cardiovascular disease: the Women's Health Study. J Natl Cancer Inst. 1999 Dec 15;91(24):2102-6. doi: 10.1093/jnci/91.24.2102."}, {"pmid"=>"10718501", "type"=>"BACKGROUND", "citation"=>"Rexrode KM, Lee IM, Cook NR, Hennekens CH, Buring JE. Baseline characteristics of participants in the Women's Health Study. J Womens Health Gend Based Med. 2000 Jan-Feb;9(1):19-27. doi: 10.1089/152460900318911."}, {"pmid"=>"11010932", "type"=>"BACKGROUND", "citation"=>"Liu S, Manson JE, Lee IM, Cole SR, Hennekens CH, Willett WC, Buring JE. Fruit and vegetable intake and risk of cardiovascular disease: the Women's Health Study. Am J Clin Nutr. 2000 Oct;72(4):922-8. doi: 10.1093/ajcn/72.4.922."}, {"pmid"=>"11255420", "type"=>"BACKGROUND", "citation"=>"Lee IM, Rexrode KM, Cook NR, Manson JE, Buring JE. Physical activity and coronary heart disease in women: is \"no pain, no gain\" passe? 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Epub 2007 Aug 14."}, {"pmid"=>"17332146", "type"=>"DERIVED", "citation"=>"Zee RY, Mora S, Cheng S, Erlich HA, Lindpaintner K, Rifai N, Buring JE, Ridker PM. Homocysteine, 5,10-methylenetetrahydrofolate reductase 677C>T polymorphism, nutrient intake, and incident cardiovascular disease in 24,968 initially healthy women. Clin Chem. 2007 May;53(5):845-51. doi: 10.1373/clinchem.2006.083881. Epub 2007 Mar 1."}, {"pmid"=>"17310025", "type"=>"DERIVED", "citation"=>"Kurth T, Everett BM, Buring JE, Kase CS, Ridker PM, Gaziano JM. Lipid levels and the risk of ischemic stroke in women. Neurology. 2007 Feb 20;68(8):556-62. doi: 10.1212/01.wnl.0000254472.41810.0d."}, {"pmid"=>"17161253", "type"=>"DERIVED", "citation"=>"Everett BM, Kurth T, Buring JE, Ridker PM. The relative strength of C-reactive protein and lipid levels as determinants of ischemic stroke compared with coronary heart disease in women. J Am Coll Cardiol. 2006 Dec 5;48(11):2235-42. doi: 10.1016/j.jacc.2006.09.030. Epub 2006 Nov 13."}, {"pmid"=>"16864722", "type"=>"DERIVED", "citation"=>"Mora S, Rifai N, Buring JE, Ridker PM. Additive value of immunoassay-measured fibrinogen and high-sensitivity C-reactive protein levels for predicting incident cardiovascular events. Circulation. 2006 Aug 1;114(5):381-7. doi: 10.1161/CIRCULATIONAHA.106.634089. Epub 2006 Jul 24."}]}, "descriptionModule"=>{"briefSummary"=>"The purpose of this study is to evaluate the effects of low-dose aspirin and vitamin E in primary prevention of cardiovascular disease and cancer in apparently healthy women.", "detailedDescription"=>"BACKGROUND:\n\nVarious doses of aspirin have been shown to be effective in preventing thrombosis or vascular occlusion in several clinical conditions. Short-term studies have documented the efficacy of aspirin in preventing occlusion of saphenous vein bypass grants, preventing myocardial infarction in patients with unstable angina, preventing transient ischemic attacks and stroke in men with cerebral vascular disease, preventing occlusion of injured coronary arteries following transluminal angioplasty and aiding in reducing myocardial infarction and total mortality in patients receiving fibrinolytic therapy. Additionally, aspirin has been effective in the secondary prevention of myocardial infarction in subjects with known coronary artery disease. The results of the Physicians' Health Study, a large-scale primary prevention trial of aspirin in male physicians, have shown a decrease in myocardial infarction, a non-significant increase in cerebral vascular events, and no difference in overall mortality. However, few studies have addressed the efficacy of aspirin in vascular diseases in women, and it is possible that the risk to benefit ratio may be different in women. Specifically, there have been no large primary prevention trials in women, who are at risk of coronary heart disease, especially after menopause.\n\nDESIGN NARRATIVE:\n\nThe Women's Health Study (WHS) is a randomized, double-blind, placebo-controlled trial using a 2x2 factorial design. The WHS is sponsored by both NHBLI (HL080467) and NCI (CA047988). Approximately 1.75 million female health professionals were contacted by mail to determine if they were suitable for inclusion in the study. A three-month run-in phase was performed to screen out those with poor compliance. Randomization, which began in February 1993 and ended in January 1996, was stratified on five-year age groups. A total of 39,876 participants were randomly assigned to either Vitamin E (600 IU every other day) or placebo; and to aspirin (100 mg every other day) or placebo. IN the 2x2 factorial design, women were randomly assigned to active aspirin and placebo vitamin E (n=9,968), placebo aspirin and active vitamin E (n=9,971), active aspirin and active vitamin E (n=9,966), or placebo aspirin and placebo vitamin E (n=9,971). A description of the characteristics of women in these 4 groups is provided in J Women's Health Gend Based Med 2000;9:19-27. In the main analyses, all women on active aspirin (n=19,934) were compared to women on placebo aspirin (n=19,942); and all women on active vitamin E (n=19,937) were compared to women on placebo aspirin (n=19,939).\n\nAs part of the initial trial, pre-randomization blood samples from 28,345 participants were frozen and stored for genetic analysis which has been supported by non-federal sources.\n\nThe primary endpoint is the reduction of the risk of all important vascular events (a combined endpoint of nonfatal myocardial infarction, nonfatal stroke, and total cardiovascular death) and a decrease in the incidence of total malignant neoplasms of epithelial cell origin. Secondary endpoints are the individual components of the combined endpoints. Compliance is measured by replies to a questionnaire sent out every year. The trial was completed in 2004 and results were published in 2005 (N Engl J Med 2005;352:1293-304; JAMA 2005;294:47-55; JAMA 2005;294:56-65).\n\nCurrently, women are being followed on an observational basis."}, "eligibilityModule"=>{"sex"=>"FEMALE", "stdAges"=>["ADULT", "OLDER_ADULT"], "minimumAge"=>"45 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria:\n\n* Healthy women\n* No previous history of cardiovascular disease or cancer\n* No contraindications to aspirin or vitamin E"}, "identificationModule"=>{"nctId"=>"NCT00000479", "acronym"=>"WHS", "briefTitle"=>"Women's Health Study (WHS): A Randomized Trial of Low-dose Aspirin and Vitamin E in the Primary Prevention of Cardiovascular Disease and Cancer", "organization"=>{"class"=>"OTHER", "fullName"=>"Brigham and Women's Hospital"}, "officialTitle"=>"Women's Health Study of Low-dose Aspirin and Vitamin E in Apparently Healthy Women", "orgStudyIdInfo"=>{"id"=>"69"}, "secondaryIdInfos"=>[{"id"=>"R01HL043851", "link"=>"https://reporter.nih.gov/quickSearch/R01HL043851", "type"=>"NIH"}, {"id"=>"HL043851"}, {"id"=>"CA047988"}]}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"EXPERIMENTAL", "label"=>"1", "description"=>"Vitamin E (600 IU every other day) and aspirin (100 mg every other day)", "interventionNames"=>["Drug: Aspirin", "Drug: Vitamin E"]}, {"type"=>"EXPERIMENTAL", "label"=>"2", "description"=>"Vitamin E (600 IU every other day) and placebo", "interventionNames"=>["Drug: Vitamin E", "Behavioral: Placebo"]}, {"type"=>"EXPERIMENTAL", "label"=>"3", "description"=>"Aspirin (100 mg every other day) and placebo", "interventionNames"=>["Drug: Aspirin", "Behavioral: Placebo"]}, {"type"=>"PLACEBO_COMPARATOR", "label"=>"4", "description"=>"Placebo and placebo", "interventionNames"=>["Behavioral: Placebo"]}], "interventions"=>[{"name"=>"Aspirin", "type"=>"DRUG", "description"=>"Participants will receive 100 mg of aspirin every other day.", "armGroupLabels"=>["1", "3"]}, {"name"=>"Vitamin E", "type"=>"DRUG", "description"=>"Participants will receive 600 IU of vitamin E every other day.", "armGroupLabels"=>["1", "2"]}, {"name"=>"Placebo", "type"=>"BEHAVIORAL", "description"=>"Participants will receive placebo.", "armGroupLabels"=>["2", "3", "4"]}]}, "contactsLocationsModule"=>{"overallOfficials"=>[{"name"=>"Julie Buring", "role"=>"PRINCIPAL_INVESTIGATOR", "affiliation"=>"Brigham and Women's Hospital"}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Brigham and Women's Hospital", "class"=>"OTHER"}, "collaborators"=>[{"name"=>"National Cancer Institute (NCI)", "class"=>"NIH"}, {"name"=>"National Heart, Lung, and Blood Institute (NHLBI)", "class"=>"NIH"}], "responsibleParty"=>{"type"=>"PRINCIPAL_INVESTIGATOR", "investigatorTitle"=>"Professor of Medicine, Harvard Medical School", "investigatorFullName"=>"Julie E. Buring", "investigatorAffiliation"=>"Brigham and Women's Hospital"}}}}