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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Epub 2010 Jun 23."}, {"ReferencePMID"=>"20511445", "ReferenceType"=>"derived", "ReferenceCitation"=>"Mora S, Kamstrup PR, Rifai N, Nordestgaard BG, Buring JE, Ridker PM. Lipoprotein(a) and risk of type 2 diabetes. Clin Chem. 2010 Aug;56(8):1252-60. doi: 10.1373/clinchem.2010.146779. Epub 2010 May 28."}, {"ReferencePMID"=>"20488302", "ReferenceType"=>"derived", "ReferenceCitation"=>"Tedrow UB, Conen D, Ridker PM, Cook NR, Koplan BA, Manson JE, Buring JE, Albert CM. The long- and short-term impact of elevated body mass index on the risk of new atrial fibrillation the WHS (women's health study). J Am Coll Cardiol. 2010 May 25;55(21):2319-27. doi: 10.1016/j.jacc.2010.02.029."}, {"ReferencePMID"=>"19395440", "ReferenceType"=>"derived", "ReferenceCitation"=>"Mora S, Rifai N, Buring JE, Ridker PM. Comparison of LDL cholesterol concentrations by Friedewald calculation and direct measurement in relation to cardiovascular events in 27,331 women. Clin Chem. 2009 May;55(5):888-94. doi: 10.1373/clinchem.2008.117929."}, {"ReferencePMID"=>"19364977", "ReferenceType"=>"derived", "ReferenceCitation"=>"Conen D, Tedrow UB, Koplan BA, Glynn RJ, Buring JE, Albert CM. Influence of systolic and diastolic blood pressure on the risk of incident atrial fibrillation in women. Circulation. 2009 Apr 28;119(16):2146-52. doi: 10.1161/CIRCULATIONAHA.108.830042. Epub 2009 Apr 13."}, {"ReferencePMID"=>"19204302", "ReferenceType"=>"derived", "ReferenceCitation"=>"Mora S, Otvos JD, Rifai N, Rosenson RS, Buring JE, Ridker PM. Lipoprotein particle profiles by nuclear magnetic resonance compared with standard lipids and apolipoproteins in predicting incident cardiovascular disease in women. Circulation. 2009 Feb 24;119(7):931-9. doi: 10.1161/CIRCULATIONAHA.108.816181. Epub 2009 Feb 9."}, {"ReferencePMID"=>"18975365", "ReferenceType"=>"derived", "ReferenceCitation"=>"Karlson EW, Shadick NA, Cook NR, Buring JE, Lee IM. Vitamin E in the primary prevention of rheumatoid arthritis: the Women's Health Study. Arthritis Rheum. 2008 Nov 15;59(11):1589-95. doi: 10.1002/art.24194."}, {"ReferencePMID"=>"18835953", "ReferenceType"=>"derived", "ReferenceCitation"=>"Pradhan AD, Cook NR, Manson JE, Ridker PM, Buring JE. A randomized trial of low-dose aspirin in the prevention of clinical type 2 diabetes in women. Diabetes Care. 2009 Jan;32(1):3-8. doi: 10.2337/dc08-1206. Epub 2008 Oct 3."}, {"ReferencePMID"=>"18687721", "ReferenceType"=>"derived", "ReferenceCitation"=>"Kurth T, Schurks M, Logroscino G, Gaziano JM, Buring JE. Migraine, vascular risk, and cardiovascular events in women: prospective cohort study. BMJ. 2008 Aug 7;337:a636. doi: 10.1136/bmj.a636."}, {"ReferencePMID"=>"18598891", "ReferenceType"=>"derived", "ReferenceCitation"=>"Suk Danik J, Rifai N, Buring JE, Ridker PM. Lipoprotein(a), hormone replacement therapy, and risk of future cardiovascular events. J Am Coll Cardiol. 2008 Jul 8;52(2):124-31. doi: 10.1016/j.jacc.2008.04.009."}, {"ReferencePMID"=>"18514203", "ReferenceType"=>"derived", "ReferenceCitation"=>"Everett BM, Bansal S, Rifai N, Buring JE, Ridker PM. Interleukin-18 and the risk of future cardiovascular disease among initially healthy women. Atherosclerosis. 2009 Jan;202(1):282-8. doi: 10.1016/j.atherosclerosis.2008.04.015. Epub 2008 Apr 22."}, {"ReferencePMID"=>"18339679", "ReferenceType"=>"derived", "ReferenceCitation"=>"Kurth T, Barr RG, Gaziano JM, Buring JE. Randomised aspirin assignment and risk of adult-onset asthma in the Women's Health Study. Thorax. 2008 Jun;63(6):514-8. doi: 10.1136/thx.2007.091447. Epub 2008 Mar 13."}, {"ReferencePMID"=>"18043905", "ReferenceType"=>"derived", "ReferenceCitation"=>"Levitan EB, Liu S, Stampfer MJ, Cook NR, Rexrode KM, Ridker PM, Buring JE, Manson JE. HbA1c measured in stored erythrocytes and mortality rate among middle-aged and older women. Diabetologia. 2008 Feb;51(2):267-75. doi: 10.1007/s00125-007-0882-y. Epub 2007 Nov 28."}, {"ReferencePMID"=>"17938390", "ReferenceType"=>"derived", "ReferenceCitation"=>"Glynn RJ, Ridker PM, Goldhaber SZ, Buring JE. Effect of low-dose aspirin on the occurrence of venous thromboembolism: a randomized trial. Ann Intern Med. 2007 Oct 16;147(8):525-33. doi: 10.7326/0003-4819-147-8-200710160-00004."}, {"ReferencePMID"=>"17704543", "ReferenceType"=>"derived", "ReferenceCitation"=>"Conen D, Ridker PM, Buring JE, Glynn RJ. Risk of cardiovascular events among women with high normal blood pressure or blood pressure progression: prospective cohort study. BMJ. 2007 Sep 1;335(7617):432. doi: 10.1136/bmj.39269.672188.AE. Epub 2007 Aug 19."}, {"ReferencePMID"=>"17701157", "ReferenceType"=>"derived", "ReferenceCitation"=>"Ding EL, Song Y, Manson JE, Rifai N, Buring JE, Liu S. Plasma sex steroid hormones and risk of developing type 2 diabetes in women: a prospective study. Diabetologia. 2007 Oct;50(10):2076-84. doi: 10.1007/s00125-007-0785-y. Epub 2007 Aug 14."}, {"ReferencePMID"=>"17332146", "ReferenceType"=>"derived", "ReferenceCitation"=>"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."}, {"ReferencePMID"=>"17310025", "ReferenceType"=>"derived", "ReferenceCitation"=>"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."}, {"ReferencePMID"=>"17161253", "ReferenceType"=>"derived", "ReferenceCitation"=>"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."}, {"ReferencePMID"=>"16864722", "ReferenceType"=>"derived", "ReferenceCitation"=>"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"=>{"Gender"=>"Female", "MinimumAge"=>"45 years", "StdAgeList"=>{"StdAge"=>["Adult", "Older Adult"]}, "HealthyVolunteers"=>"No", "EligibilityCriteria"=>"Inclusion Criteria:\n\nHealthy women\nNo previous history of cardiovascular disease or cancer\nNo 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"=>{"OrgClass"=>"OTHER", "OrgFullName"=>"Brigham and Women's Hospital"}, "OfficialTitle"=>"Women's Health Study of Low-dose Aspirin and Vitamin E in Apparently Healthy Women", "OrgStudyIdInfo"=>{"OrgStudyId"=>"69"}, "SecondaryIdInfoList"=>{"SecondaryIdInfo"=>[{"SecondaryId"=>"R01HL043851", "SecondaryIdLink"=>"https://reporter.nih.gov/quickSearch/R01HL043851", "SecondaryIdType"=>"U.S. NIH Grant/Contract"}, {"SecondaryId"=>"HL043851"}, {"SecondaryId"=>"CA047988"}]}}, "ArmsInterventionsModule"=>{"ArmGroupList"=>{"ArmGroup"=>[{"ArmGroupType"=>"Experimental", "ArmGroupLabel"=>"1", "ArmGroupDescription"=>"Vitamin E (600 IU every other day) and aspirin (100 mg every other day)", "ArmGroupInterventionList"=>{"ArmGroupInterventionName"=>["Drug: Aspirin", "Drug: Vitamin E"]}}, {"ArmGroupType"=>"Experimental", "ArmGroupLabel"=>"2", "ArmGroupDescription"=>"Vitamin E (600 IU every other day) and placebo", "ArmGroupInterventionList"=>{"ArmGroupInterventionName"=>["Drug: Vitamin E", "Behavioral: Placebo"]}}, {"ArmGroupType"=>"Experimental", "ArmGroupLabel"=>"3", "ArmGroupDescription"=>"Aspirin (100 mg every other day) and placebo", "ArmGroupInterventionList"=>{"ArmGroupInterventionName"=>["Drug: Aspirin", "Behavioral: Placebo"]}}, {"ArmGroupType"=>"Placebo Comparator", "ArmGroupLabel"=>"4", "ArmGroupDescription"=>"Placebo and placebo", "ArmGroupInterventionList"=>{"ArmGroupInterventionName"=>["Behavioral: Placebo"]}}]}, "InterventionList"=>{"Intervention"=>[{"InterventionName"=>"Aspirin", "InterventionType"=>"Drug", "InterventionDescription"=>"Participants will receive 100 mg of aspirin every other day.", "InterventionArmGroupLabelList"=>{"InterventionArmGroupLabel"=>["1", "3"]}}, {"InterventionName"=>"Vitamin E", "InterventionType"=>"Drug", "InterventionDescription"=>"Participants will receive 600 IU of vitamin E every other day.", "InterventionArmGroupLabelList"=>{"InterventionArmGroupLabel"=>["1", "2"]}}, {"InterventionName"=>"Placebo", "InterventionType"=>"Behavioral", "InterventionDescription"=>"Participants will receive placebo.", "InterventionArmGroupLabelList"=>{"InterventionArmGroupLabel"=>["2", "3", "4"]}}]}}, "ContactsLocationsModule"=>{"OverallOfficialList"=>{"OverallOfficial"=>[{"OverallOfficialName"=>"Julie Buring", "OverallOfficialRole"=>"Principal Investigator", "OverallOfficialAffiliation"=>"Brigham and Women's Hospital"}]}}, "SponsorCollaboratorsModule"=>{"LeadSponsor"=>{"LeadSponsorName"=>"Brigham and Women's Hospital", "LeadSponsorClass"=>"OTHER"}, "CollaboratorList"=>{"Collaborator"=>[{"CollaboratorName"=>"National Cancer Institute (NCI)", "CollaboratorClass"=>"NIH"}, {"CollaboratorName"=>"National Heart, Lung, and Blood Institute (NHLBI)", "CollaboratorClass"=>"NIH"}]}, "ResponsibleParty"=>{"ResponsiblePartyType"=>"Principal Investigator", "ResponsiblePartyInvestigatorTitle"=>"Professor of Medicine, Harvard Medical School", "ResponsiblePartyInvestigatorFullName"=>"Julie E. Buring", "ResponsiblePartyInvestigatorAffiliation"=>"Brigham and Women's Hospital"}}}}}}
Trial Information
Current as of December 10, 2023
Completed
Keywords
Description
BACKGROUND: Various 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 fibri...
Gender
Female
Eligibility criteria
- Inclusion Criteria:
- Healthy women
- No previous history of cardiovascular disease or cancer
- No contraindications to aspirin or vitamin E
Attachments
4.5 MB
4.5 MB
About company
The National Institute of Allergy and Infectious Diseases (NIAID, /ˈnaɪ.æd/) is one of the 27 institutes and centers that make up the National Institutes of Health (NIH), an agency of the United States Department of Health and Human Services (HHS). NIAID's mission is to conduct basic and applied research to better understand, treat, and prevent infectious, immunologic, and allergic diseases.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
People applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Average follow-up 10.1 years
Reviews (48)
All reviews come from applied patients

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Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

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