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Study record managers: refer to the Data Element Definitions if submitting registration or information. 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 fibrinolytic therapy.
Additionally, aspirin has been effective in the secondary prevention of myocardial infarction in subjects with known coronary artery disease. The 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-ificant 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. Approximately 1. A three-month run-in phase was performed to screen out those with poor compliance.
Randomization, which began in February and ended in Januarywas stratified on five-year age groups. A total of 39, participants were randomly ased to either Vitamin E IU every other day or placebo; and to aspirin mg every other day or placebo. A description of the characteristics of women in these 4 groups is provided in J Women's Health Gend Based Med ; As part of the initial trial, pre-randomization blood samples from 28, participants were frozen and stored for genetic analysis which has been supported by non-federal sources. The 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 Cirque du sex Leiden date sept 1 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. Currently, women are being followed on an observational basis. Behavioral: Placebo Participants will receive placebo.
Experimental: 3 Aspirin mg every other day and placebo Drug: Aspirin Participants will receive mg of aspirin every other day. Talk with your doctor and family members or friends about deciding to a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below.
For general information, Learn About Clinical Studies. Hide glossary Glossary Study record managers: refer to the Data Element Definitions if submitting registration or information. Search for terms x. Save this study. Warning You have reached the maximum of saved studies Listing a study does not mean it has been evaluated by the U.
Federal Government. Read our disclaimer for details. First Posted : June 13, Last Update Posted : June 15, Study Description. 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. Detailed Description:. FDA Resources. Arms and Interventions. Participants will receive mg of aspirin every other day.
Participants will receive IU of vitamin E every other day. Outcome Measures. Eligibility Criteria. Information from the National Library of Medicine Choosing to participate in a study is an important personal decision. Inclusion Criteria: Healthy women No history of cardiovascular disease or cancer No contraindications to aspirin or vitamin E. Contacts and Locations. Information from the National Library of Medicine To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials. More Information. Ethnic distribution of factor V Leiden in men and women. Implications for venous thromboembolism screening. Prospective study of C-reactive protein and the risk of future cardiovascular events among apparently healthy women. Hormone replacement therapy and increased plasma concentration of C-reactive protein. Beta-carotene supplementation and incidence of cancer and cardiovascular disease: the Women's Health Study.
J Natl Cancer Inst. Baseline characteristics of participants in the Women's Health Study. Fruit and vegetable intake and risk of cardiovascular disease: the Women's Health Study. Am J Clin Nutr. C-reactive protein, interleukin 6, and risk of developing type 2 diabetes mellitus.
Maternal and paternal history of myocardial infarction and risk of cardiovascular disease in men and women. C-reactive protein and other markers of inflammation in the prediction of cardiovascular disease in women. N Engl J Med. Low-density lipoprotein particle concentration and size as determined by nuclear magnetic resonance spectroscopy as predictors of cardiovascular disease in women. Migraine and coronary heart disease in women and men. Relation between a diet with Cirque du sex Leiden date sept 1 high glycemic load and plasma concentrations of high-sensitivity C-reactive protein in middle-aged women.
Estrogen-progestin replacement therapy and breast cancer risk: the Women's Health Study United States. Cancer Causes Control.
Comparison of C-reactive protein and low-density lipoprotein cholesterol levels in the prediction of first cardiovascular events. C-reactive protein, the metabolic syndrome, and risk of incident cardiovascular events: an 8-year follow-up of 14 initially healthy American women.
Insulin, proinsulin, proinsulin:insulin ratio, and the risk of developing type 2 diabetes mellitus in women. Am J Med. A prospective study of sugar intake and risk of type 2 diabetes in women. Diabetes Care. Interobserver agreement in the classification of stroke in the Women's Health Study.
Ridker PM, Cook N. Clinical usefulness of very high and very low levels of C-reactive protein across the full range of Framingham Risk Scores. Epub Mar C-reactive protein levels among women of various ethnic groups living in the United States from the Women's Health Study. Am J Cardiol. Dietary fat and fatty acids and risk of colorectal cancer in women. Am J Epidemiol. Relationship of physical activity vs body mass index with type 2 diabetes in women.
Age-related cataract in a randomized trial of beta-carotene in women. Ophthalmic Epidemiol. C-reactive protein levels are not associated with increased risk for colorectal cancer in women.
Ann Intern Med.Cirque du sex Leiden date sept 1
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Women's Health Study (WHS): A Randomized Trial of Low-dose Aspirin and Vitamin E in the Primary Prevention of Cardiovascular Disease and Cancer (WHS)