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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)

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ClinicalTrials.gov Identifier: NCT00000479
Recruitment Status : Completed
First Posted : October 28, 1999
Results First Posted : June 13, 2012
Last Update Posted : June 15, 2012
Sponsor:
Collaborators:
National Cancer Institute (NCI)
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Julie E. Buring, Brigham and Women's Hospital

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Factorial Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Conditions Cardiovascular Diseases
Cerebrovascular Disorders
Coronary Disease
Heart Diseases
Myocardial Infarction
Myocardial Ischemia
Vascular Diseases
Interventions Drug: Aspirin
Drug: Vitamin E
Behavioral: Placebo
Enrollment 39876
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Aspirin Only Vitamin E Only Aspirin + Vitamin E Both Placebos
Hide Arm/Group Description Aspirin(100 mg every other day)and placebo vitamin E Placebo aspirin and vitamin E (600 IU every other day Aspirin (100 mg every other day) and vitamin E (600 IU every other day) Placebo aspirin and placebo vitamin E
Period Title: Overall Study
Started 9968 9971 9966 9971
Completed 9968 9971 9966 9971
Not Completed 0 0 0 0
Arm/Group Title Aspirin Only Vitamin E Only Aspirin + Vitamin E Both Placebos Total
Hide Arm/Group Description Aspirin(100 mg every other day)and placebo vitamin E Placebo aspirin and vitamin E (600 IU every other day Aspirin (100 mg every other day) and vitamin E (600 IU every other day) Placebo aspirin and placebo vitamin E Total of all reporting groups
Overall Number of Baseline Participants 9968 9971 9966 9971 39876
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9968 participants 9971 participants 9966 participants 9971 participants 39876 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
8981
  90.1%
8974
  90.0%
8969
  90.0%
8984
  90.1%
35908
  90.0%
>=65 years
987
   9.9%
997
  10.0%
997
  10.0%
987
   9.9%
3968
  10.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 9968 participants 9971 participants 9966 participants 9971 participants 39876 participants
53.9  (7.1) 53.9  (7.1) 53.9  (7.1) 53.9  (7.1) 53.9  (7.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9968 participants 9971 participants 9966 participants 9971 participants 39876 participants
Female
9968
 100.0%
9971
 100.0%
9966
 100.0%
9971
 100.0%
39876
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 9968 participants 9971 participants 9966 participants 9971 participants 39876 participants
9968 9971 9966 9971 39876
1.Primary Outcome
Title Number of Participants With Major Cardiovascular Events (a Combined Endpoint of Nonfatal Myocardial Infarction, Nonfatal Stroke, and Total Cardiovascular Death)
Hide Description [Not Specified]
Time Frame Average follow-up 10.1 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Aspirin Only Vitamin E Only Aspirin + Vitamin E Both Placebos
Hide Arm/Group Description:
Aspirin(100 mg every other day)and placebo vitamin E
Placebo aspirin and vitamin E (600 IU every other day
Aspirin (100 mg every other day) and vitamin E (600 IU every other day)
Placebo aspirin and placebo vitamin E
Overall Number of Participants Analyzed 9968 9971 9966 9971
Measure Type: Number
Unit of Measure: Participants
Major cardiovascular event 245 250 232 272
Stroke 113 133 108 133
Myocardial infarction 96 94 102 99
Cardiovascular death 66 52 54 74
2.Primary Outcome
Title Number of Participants With Cancer, Excluding Nonmelanoma Skin Cancer
Hide Description [Not Specified]
Time Frame Average follow-up 10.1 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Aspirin Only Vitamin E Only Aspirin + Vitamin E Both Placebos
Hide Arm/Group Description:
Aspirin(100 mg every other day)and placebo vitamin E
Placebo aspirin and vitamin E (600 IU every other day
Aspirin (100 mg every other day) and vitamin E (600 IU every other day)
Placebo aspirin and placebo vitamin E
Overall Number of Participants Analyzed 9968 9971 9966 9971
Measure Type: Number
Unit of Measure: participants
Total invasive cancer 722 721 716 706
Cancer death 132 156 152 143
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Aspirin Only Vitamin E Only Aspirin + Vitamin E Both Placebos
Hide Arm/Group Description Aspirin(100 mg every other day)and placebo vitamin E Placebo aspirin and vitamin E (600 IU every other day Aspirin (100 mg every other day) and vitamin E (600 IU every other day) Placebo aspirin and placebo vitamin E
All-Cause Mortality
Aspirin Only Vitamin E Only Aspirin + Vitamin E Both Placebos
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Aspirin Only Vitamin E Only Aspirin + Vitamin E Both Placebos
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   27/9968 (0.27%)      20/9971 (0.20%)      24/9966 (0.24%)      21/9971 (0.21%)    
Blood and lymphatic system disorders         
hemorrhagic stroke  1  27/9968 (0.27%)  27 20/9971 (0.20%)  20 24/9966 (0.24%)  24 21/9971 (0.21%)  21
Indicates events were collected by systematic assessment
1
Term from vocabulary, ICD
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Aspirin Only Vitamin E Only Aspirin + Vitamin E Both Placebos
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   5969/9968 (59.88%)      5915/9971 (59.32%)      5887/9966 (59.07%)      6000/9971 (60.17%)    
Blood and lymphatic system disorders         
hematuria  1  1534/9968 (15.39%)  1534 1467/9971 (14.71%)  1467 1505/9966 (15.10%)  1505 1411/9971 (14.15%)  1411
easy bruising  1  5297/9968 (53.14%)  5297 4247/9971 (42.59%)  4247 5263/9966 (52.81%)  5263 4247/9971 (42.59%)  4247
epistaxis  1  1854/9968 (18.60%)  1854 1703/9971 (17.08%)  1703 1947/9966 (19.54%)  1947 1618/9971 (16.23%)  1618
Gastrointestinal disorders         
report of GI upset  1  5969/9968 (59.88%)  5969 5915/9971 (59.32%)  5915 5887/9966 (59.07%)  5887 6000/9971 (60.17%)  6000
Indicates events were collected by systematic assessment
1
Term from vocabulary, ICD
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Julie E. Buring
Organization: Brigham and Women's Hospital
Phone: 617 732 4965
EMail: jburing@rics.bwh.harvard.edu
Publications:
Buring JE, Hennekens CH for the Women's Health Study Research Group. The Women's Health Study: rationale and background. J Myocardial Ischemia, 4:30-40, 1992.
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Julie E. Buring, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT00000479     History of Changes
Other Study ID Numbers: 69
R01HL043851 ( U.S. NIH Grant/Contract )
HL043851
CA047988
First Submitted: October 27, 1999
First Posted: October 28, 1999
Results First Submitted: December 5, 2011
Results First Posted: June 13, 2012
Last Update Posted: June 15, 2012