Trial · NCT00000479
Women's Health Study (WHS): A Randomized Trial of Low-dose Aspirin and Vitamin E in the Primary Prevention of Cardiovascular Disease and Cancer
NCT00000479, Phase 3, Completed, Brigham and Women's Hospital; results first posted 2012-06-13
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Women's Health Study (WHS): A Randomized Trial of Low-dose Aspirin and Vitamin E in the Primary Prevention of Cardiovascular Disease and Cancer. Trials, record NCT00000479. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00000479
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Women's Health Study (WHS): A Randomized Trial of Low-dose Aspirin and Vitamin E in the Primary Prevention of Cardiovascular Disease and Cancer
- NCT number
- NCT00000479
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 39,876 participants, actual
- Lead sponsor
- Brigham and Women's Hospital
- Conditions
- Cardiovascular Diseases, Cerebrovascular Disorders, Coronary Disease, Heart Diseases, Myocardial Infarction, Myocardial Ischemia, Vascular Diseases
- Interventions
- Aspirin, Vitamin E, Placebo
- First posted
- 1999-10-28
- Last updated
- 2012-06-15
- Results first posted
- 2012-06-13
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Major Cardiovascular Events (a Combined Endpoint of Nonfatal Myocardial Infarction, Nonfatal Stroke, and Total Cardiovascular Death) | Average follow-up 10.1 years | |
| Primary | Number of Participants With Cancer, Excluding Nonmelanoma Skin Cancer | Average follow-up 10.1 years |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Major Cardiovascular Events (a Combined Endpoint of Nonfatal Myocardial Infarction, Nonfatal Stroke, and Total Cardiovascular Death) | Average follow-up 10.1 years | Participants | NUMBER | |
| PRIMARY | Number of Participants With Cancer, Excluding Nonmelanoma Skin Cancer | Average follow-up 10.1 years | participants | NUMBER |
Source ClinicalTrials.gov
Results by group24
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Major Cardiovascular Events (a Combined Endpoint of Nonfatal Myocardial Infarction, Nonfatal Stroke, and Total Cardiovascular Death) | Aspirin Only | Major cardiovascular event | 245 | 0.80 to 1.03 | Participants |
| Number of Participants With Major Cardiovascular Events (a Combined Endpoint of Nonfatal Myocardial Infarction, Nonfatal Stroke, and Total Cardiovascular Death) | Vitamin E Only | Major cardiovascular event | 250 | 0.82 to 1.05 | Participants |
| Number of Participants With Major Cardiovascular Events (a Combined Endpoint of Nonfatal Myocardial Infarction, Nonfatal Stroke, and Total Cardiovascular Death) | Aspirin + Vitamin E | Major cardiovascular event | 232 | Participants | |
| Number of Participants With Major Cardiovascular Events (a Combined Endpoint of Nonfatal Myocardial Infarction, Nonfatal Stroke, and Total Cardiovascular Death) | Both Placebos | Major cardiovascular event | 272 | Participants | |
| Number of Participants With Major Cardiovascular Events (a Combined Endpoint of Nonfatal Myocardial Infarction, Nonfatal Stroke, and Total Cardiovascular Death) | Aspirin Only | Stroke | 113 | 0.69 to 0.99 | Participants |
| Number of Participants With Major Cardiovascular Events (a Combined Endpoint of Nonfatal Myocardial Infarction, Nonfatal Stroke, and Total Cardiovascular Death) | Vitamin E Only | Stroke | 133 | 0.82 to 1.17 | Participants |
| Number of Participants With Major Cardiovascular Events (a Combined Endpoint of Nonfatal Myocardial Infarction, Nonfatal Stroke, and Total Cardiovascular Death) | Aspirin + Vitamin E | Stroke | 108 | Participants | |
| Number of Participants With Major Cardiovascular Events (a Combined Endpoint of Nonfatal Myocardial Infarction, Nonfatal Stroke, and Total Cardiovascular Death) | Both Placebos | Stroke | 133 | Participants | |
| Number of Participants With Major Cardiovascular Events (a Combined Endpoint of Nonfatal Myocardial Infarction, Nonfatal Stroke, and Total Cardiovascular Death) | Aspirin Only | Myocardial infarction | 96 | 0.84 to 1.25 | Participants |
| Number of Participants With Major Cardiovascular Events (a Combined Endpoint of Nonfatal Myocardial Infarction, Nonfatal Stroke, and Total Cardiovascular Death) | Vitamin E Only | Myocardial infarction | 94 | 0.82 to 1.23 | Participants |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Aspirin Only | 9,968 | |
| Overall Study | STARTED | Vitamin E Only | 9,971 | |
| Overall Study | STARTED | Aspirin + Vitamin E | 9,966 | |
| Overall Study | STARTED | Both Placebos | 9,971 | |
| Overall Study | COMPLETED | Aspirin Only | 9,968 | |
| Overall Study | COMPLETED | Vitamin E Only | 9,971 | |
| Overall Study | COMPLETED | Aspirin + Vitamin E | 9,966 | |
| Overall Study | COMPLETED | Both Placebos | 9,971 | |
| Overall Study | NOT COMPLETED | Aspirin Only | 0 | |
| Overall Study | NOT COMPLETED | Vitamin E Only | 0 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events20
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | hematuria | Blood and lymphatic system disorders | Aspirin Only | 1,534 | 9,968 | 1,534 |
| other | hematuria | Blood and lymphatic system disorders | Vitamin E Only | 1,467 | 9,971 | 1,467 |
| other | hematuria | Blood and lymphatic system disorders | Aspirin + Vitamin E | 1,505 | 9,966 | 1,505 |
| other | hematuria | Blood and lymphatic system disorders | Both Placebos | 1,411 | 9,971 | 1,411 |
| other | easy bruising | Blood and lymphatic system disorders | Aspirin Only | 5,297 | 9,968 | 5,297 |
| other | easy bruising | Blood and lymphatic system disorders | Vitamin E Only | 4,247 | 9,971 | 4,247 |
| other | easy bruising | Blood and lymphatic system disorders | Aspirin + Vitamin E | 5,263 | 9,966 | 5,263 |
| other | easy bruising | Blood and lymphatic system disorders | Both Placebos | 4,247 | 9,971 | 4,247 |
| other | epistaxis | Blood and lymphatic system disorders | Aspirin Only | 1,854 | 9,968 | 1,854 |
| other | epistaxis | Blood and lymphatic system disorders | Vitamin E Only | 1,703 | 9,971 | 1,703 |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Aspirin Only | ||
| Total, all-cause mortality | Vitamin E Only | ||
| Total, all-cause mortality | Aspirin + Vitamin E | ||
| Total, all-cause mortality | Both Placebos | ||
| Total, other adverse events | Aspirin Only | 5,969 | 9,968 |
| Total, other adverse events | Vitamin E Only | 5,915 | 9,971 |
| Total, other adverse events | Aspirin + Vitamin E | 5,887 | 9,966 |
| Total, other adverse events | Both Placebos | 6,000 | 9,971 |
| Total, serious adverse events | Aspirin Only | 27 | 9,968 |
| Total, serious adverse events | Vitamin E Only | 20 | 9,971 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers136
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00000479
GET https://conductscience.org/api/trials/v1/NCT00000479/results?page=2