Women's Health Study (WHS): A Randomized Trial of Low-dose Aspirin and Vitamin E in the Primary Prevention of Cardiovascular Disease and Cancer

This study has been completed.
Sponsor:
Collaborators:
Information provided by (Responsible Party):
Julie E. Buring, Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT00000479
First received: October 27, 1999
Last updated: June 12, 2012
Last verified: June 2012
Results First Received: December 5, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Factorial Assignment;   Masking: Double Blind (Subject, 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

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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

Participant Flow:   Overall Study
    Aspirin Only     Vitamin E Only     Aspirin + Vitamin E     Both Placebos  
STARTED     9968     9971     9966     9971  
COMPLETED     9968     9971     9966     9971  
NOT COMPLETED     0     0     0     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
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
Total Total of all reporting groups

Baseline Measures
    Aspirin Only     Vitamin E Only     Aspirin + Vitamin E     Both Placebos     Total  
Number of Participants  
[units: participants]
  9968     9971     9966     9971     39876  
Age  
[units: participants]
         
<=18 years     0     0     0     0     0  
Between 18 and 65 years     8981     8974     8969     8984     35908  
>=65 years     987     997     997     987     3968  
Age  
[units: years]
Mean ± Standard Deviation
  53.9  ± 7.1     53.9  ± 7.1     53.9  ± 7.1     53.9  ± 7.1     53.9  ± 7.1  
Gender  
[units: participants]
         
Female     9968     9971     9966     9971     39876  
Male     0     0     0     0     0  
Region of Enrollment  
[units: participants]
         
United States     9968     9971     9966     9971     39876  



  Outcome Measures
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1.  Primary:   Number of Participants With Major Cardiovascular Events (a Combined Endpoint of Nonfatal Myocardial Infarction, Nonfatal Stroke, and Total Cardiovascular Death)   [ Time Frame: Average follow-up 10.1 years ]

2.  Primary:   Number of Participants With Cancer, Excluding Nonmelanoma Skin Cancer   [ Time Frame: Average follow-up 10.1 years ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Julie E. Buring
Organization: Brigham and Women's Hospital
phone: 617 732 4965
e-mail: jburing@rics.bwh.harvard.edu


Publications:
Bassuk SS, Ridker PM, Manson JE, Buring JE. Aspirin and cardiovascular disease prevention in women: new findings from the Women's Health Study. Women's Health, 1:9-10, 2005.
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:


Responsible Party: Julie E. Buring, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT00000479     History of Changes
Other Study ID Numbers: 69, R01HL043851, HL043851, CA047988
Study First Received: October 27, 1999
Results First Received: December 5, 2011
Last Updated: June 12, 2012
Health Authority: United States: Federal Government