Trial Outcomes & Findings for 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 NCT00000479)
NCT ID: NCT00000479
Last Updated: 2012-06-15
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
39876 participants
Primary outcome timeframe
Average follow-up 10.1 years
Results posted on
2012-06-15
Participant Flow
Participant milestones
| Measure |
Aspirin Only
Aspirin(100 mg every other day)and placebo vitamin E
|
Vitamin E Only
Placebo aspirin and vitamin E (600 IU every other day
|
Aspirin + Vitamin E
Aspirin (100 mg every other day) and vitamin E (600 IU every other day)
|
Both Placebos
Placebo aspirin and placebo vitamin E
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
9968
|
9971
|
9966
|
9971
|
|
Overall Study
COMPLETED
|
9968
|
9971
|
9966
|
9971
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Women's Health Study (WHS): A Randomized Trial of Low-dose Aspirin and Vitamin E in the Primary Prevention of Cardiovascular Disease and Cancer
Baseline characteristics by cohort
| Measure |
Aspirin Only
n=9968 Participants
Aspirin(100 mg every other day)and placebo vitamin E
|
Vitamin E Only
n=9971 Participants
Placebo aspirin and vitamin E (600 IU every other day
|
Aspirin + Vitamin E
n=9966 Participants
Aspirin (100 mg every other day) and vitamin E (600 IU every other day)
|
Both Placebos
n=9971 Participants
Placebo aspirin and placebo vitamin E
|
Total
n=39876 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
8981 Participants
n=93 Participants
|
8974 Participants
n=4 Participants
|
8969 Participants
n=27 Participants
|
8984 Participants
n=483 Participants
|
35908 Participants
n=36 Participants
|
|
Age, Categorical
>=65 years
|
987 Participants
n=93 Participants
|
997 Participants
n=4 Participants
|
997 Participants
n=27 Participants
|
987 Participants
n=483 Participants
|
3968 Participants
n=36 Participants
|
|
Age, Continuous
|
53.9 years
STANDARD_DEVIATION 7.1 • n=93 Participants
|
53.9 years
STANDARD_DEVIATION 7.1 • n=4 Participants
|
53.9 years
STANDARD_DEVIATION 7.1 • n=27 Participants
|
53.9 years
STANDARD_DEVIATION 7.1 • n=483 Participants
|
53.9 years
STANDARD_DEVIATION 7.1 • n=36 Participants
|
|
Sex: Female, Male
Female
|
9968 Participants
n=93 Participants
|
9971 Participants
n=4 Participants
|
9966 Participants
n=27 Participants
|
9971 Participants
n=483 Participants
|
39876 Participants
n=36 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Region of Enrollment
United States
|
9968 participants
n=93 Participants
|
9971 participants
n=4 Participants
|
9966 participants
n=27 Participants
|
9971 participants
n=483 Participants
|
39876 participants
n=36 Participants
|
PRIMARY outcome
Timeframe: Average follow-up 10.1 yearsOutcome measures
| Measure |
Aspirin Only
n=9968 Participants
Aspirin(100 mg every other day)and placebo vitamin E
|
Vitamin E Only
n=9971 Participants
Placebo aspirin and vitamin E (600 IU every other day
|
Aspirin + Vitamin E
n=9966 Participants
Aspirin (100 mg every other day) and vitamin E (600 IU every other day)
|
Both Placebos
n=9971 Participants
Placebo aspirin and placebo vitamin E
|
|---|---|---|---|---|
|
Number of Participants With Major Cardiovascular Events (a Combined Endpoint of Nonfatal Myocardial Infarction, Nonfatal Stroke, and Total Cardiovascular Death)
Major cardiovascular event
|
245 Participants
Interval 0.8 to 1.03
|
250 Participants
Interval 0.82 to 1.05
|
232 Participants
|
272 Participants
|
|
Number of Participants With Major Cardiovascular Events (a Combined Endpoint of Nonfatal Myocardial Infarction, Nonfatal Stroke, and Total Cardiovascular Death)
Stroke
|
113 Participants
Interval 0.69 to 0.99
|
133 Participants
Interval 0.82 to 1.17
|
108 Participants
|
133 Participants
|
|
Number of Participants With Major Cardiovascular Events (a Combined Endpoint of Nonfatal Myocardial Infarction, Nonfatal Stroke, and Total Cardiovascular Death)
Myocardial infarction
|
96 Participants
Interval 0.84 to 1.25
|
94 Participants
Interval 0.82 to 1.23
|
102 Participants
|
99 Participants
|
|
Number of Participants With Major Cardiovascular Events (a Combined Endpoint of Nonfatal Myocardial Infarction, Nonfatal Stroke, and Total Cardiovascular Death)
Cardiovascular death
|
66 Participants
Interval 0.74 to 1.22
|
52 Participants
Interval 0.59 to 0.98
|
54 Participants
|
74 Participants
|
PRIMARY outcome
Timeframe: Average follow-up 10.1 yearsOutcome measures
| Measure |
Aspirin Only
n=9968 Participants
Aspirin(100 mg every other day)and placebo vitamin E
|
Vitamin E Only
n=9971 Participants
Placebo aspirin and vitamin E (600 IU every other day
|
Aspirin + Vitamin E
n=9966 Participants
Aspirin (100 mg every other day) and vitamin E (600 IU every other day)
|
Both Placebos
n=9971 Participants
Placebo aspirin and placebo vitamin E
|
|---|---|---|---|---|
|
Number of Participants With Cancer, Excluding Nonmelanoma Skin Cancer
Total invasive cancer
|
722 participants
Interval 0.94 to 1.08
|
721 participants
Interval 0.94 to 1.08
|
716 participants
|
706 participants
|
|
Number of Participants With Cancer, Excluding Nonmelanoma Skin Cancer
Cancer death
|
132 participants
Interval 0.81 to 1.11
|
156 participants
Interval 0.95 to 1.32
|
152 participants
|
143 participants
|
Adverse Events
Aspirin Only
Serious events: 27 serious events
Other events: 5969 other events
Deaths: 0 deaths
Vitamin E Only
Serious events: 20 serious events
Other events: 5915 other events
Deaths: 0 deaths
Aspirin + Vitamin E
Serious events: 24 serious events
Other events: 5887 other events
Deaths: 0 deaths
Both Placebos
Serious events: 21 serious events
Other events: 6000 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Aspirin Only
n=9968 participants at risk
Aspirin(100 mg every other day)and placebo vitamin E
|
Vitamin E Only
n=9971 participants at risk
Placebo aspirin and vitamin E (600 IU every other day
|
Aspirin + Vitamin E
n=9966 participants at risk
Aspirin (100 mg every other day) and vitamin E (600 IU every other day)
|
Both Placebos
n=9971 participants at risk
Placebo aspirin and placebo vitamin E
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
hemorrhagic stroke
|
0.27%
27/9968 • Number of events 27
|
0.20%
20/9971 • Number of events 20
|
0.24%
24/9966 • Number of events 24
|
0.21%
21/9971 • Number of events 21
|
Other adverse events
| Measure |
Aspirin Only
n=9968 participants at risk
Aspirin(100 mg every other day)and placebo vitamin E
|
Vitamin E Only
n=9971 participants at risk
Placebo aspirin and vitamin E (600 IU every other day
|
Aspirin + Vitamin E
n=9966 participants at risk
Aspirin (100 mg every other day) and vitamin E (600 IU every other day)
|
Both Placebos
n=9971 participants at risk
Placebo aspirin and placebo vitamin E
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
hematuria
|
15.4%
1534/9968 • Number of events 1534
|
14.7%
1467/9971 • Number of events 1467
|
15.1%
1505/9966 • Number of events 1505
|
14.2%
1411/9971 • Number of events 1411
|
|
Blood and lymphatic system disorders
easy bruising
|
53.1%
5297/9968 • Number of events 5297
|
42.6%
4247/9971 • Number of events 4247
|
52.8%
5263/9966 • Number of events 5263
|
42.6%
4247/9971 • Number of events 4247
|
|
Blood and lymphatic system disorders
epistaxis
|
18.6%
1854/9968 • Number of events 1854
|
17.1%
1703/9971 • Number of events 1703
|
19.5%
1947/9966 • Number of events 1947
|
16.2%
1618/9971 • Number of events 1618
|
|
Gastrointestinal disorders
report of GI upset
|
59.9%
5969/9968 • Number of events 5969
|
59.3%
5915/9971 • Number of events 5915
|
59.1%
5887/9966 • Number of events 5887
|
60.2%
6000/9971 • Number of events 6000
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place