Phase 3
N=39,876
Women's Health Study (WHS): A Randomized Trial of Low-dose Aspirin and Vitamin E in the Primary Prevention of Cardiovascular Disease and Cancer
Cardiovascular Diseases · Cerebrovascular Disorders · Coronary Disease · Heart Diseases · Myocardial Infarction
Bottom Line
View on ClinicalTrials.gov: NCT00000479 ↗Enrolled (actual)
39,876
Serious AEs
0.2%
Results posted
Jun 2012
Primary outcome: Primary: Number of Participants With Major Cardiovascular Events (a Combined Endpoint of Nonfatal Myocardial Infarction, Nonfatal Stroke, and Total Cardiovascular Death) — 245; 250; 232; 272 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Aspirin (Drug); Vitamin E (Drug); Placebo (Behavioral)
- Age
- Adult, Older Adult · 45+ yrs
- Sex
- Female
- Sponsor
- Brigham and Women's Hospital
- Primary completion
- Mar 2004
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Major Cardiovascular Events (a Combined Endpoint of Nonfatal Myocardial Infarction, Nonfatal Stroke, and Total Cardiovascular Death) |
245; 250; 232; 272; 113; 133 | — |
| PRIMARY Number of Participants With Cancer, Excluding Nonmelanoma Skin Cancer |
722; 721; 716; 706; 132; 156 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Healthy women
- No previous history of cardiovascular disease or cancer
- No contraindications to aspirin or vitamin E
Data sourced from ClinicalTrials.gov (NCT00000479). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.