Ignite Creation Date:
2024-05-05 @ 11:19 AM
Last Modification Date:
2024-10-26 @ 9:01 AM
Study NCT ID:
NCT00000479
Status:
COMPLETED
Last Update Posted:
2012-06-15
First Post:
1999-10-27
Brief Title:
Womens Health Study WHS A Randomized Trial of Low-dose Aspirin and Vitamin E in the Primary Prevention of Cardiovascular Disease and Cancer
Sponsor:
Brigham and Womens Hospital
Organization:
Brigham and Womens Hospital
Study Overview
Official Title:
Womens Health Study of Low-dose Aspirin and Vitamin E in Apparently Healthy Women
Status:
COMPLETED
Status Verified Date:
2012-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
WHS
Brief Summary:
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:
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 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
DESIGN NARRATIVE
The Womens 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 175 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 39876 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 n9968 placebo aspirin and active vitamin E n9971 active aspirin and active vitamin E n9966 or placebo aspirin and placebo vitamin E n9971 A description of the characteristics of women in these 4 groups is provided in J Womens Health Gend Based Med 2000919-27 In the main analyses all women on active aspirin n19934 were compared to women on placebo aspirin n19942 and all women on active vitamin E n19937 were compared to women on placebo aspirin n19939
As part of the initial trial pre-randomization blood samples from 28345 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 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 20053521293-304 JAMA 200529447-55 JAMA 200529456-65
Currently women are being followed on an observational basis
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 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
DESIGN NARRATIVE
The Womens 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 175 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 39876 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 n9968 placebo aspirin and active vitamin E n9971 active aspirin and active vitamin E n9966 or placebo aspirin and placebo vitamin E n9971 A description of the characteristics of women in these 4 groups is provided in J Womens Health Gend Based Med 2000919-27 In the main analyses all women on active aspirin n19934 were compared to women on placebo aspirin n19942 and all women on active vitamin E n19937 were compared to women on placebo aspirin n19939
As part of the initial trial pre-randomization blood samples from 28345 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 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 20053521293-304 JAMA 200529447-55 JAMA 200529456-65
Currently women are being followed on an observational basis
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01HL043851 | NIH | None | None |
| HL043851 | None | None | None |
| CA047988 | US NIH GrantContract | None | httpsreporternihgovquickSearchR01HL043851 |