We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00000479
First Posted: October 28, 1999
Last Update Posted: March 17, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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
Results First Submitted: December 5, 2011  
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

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

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
  Hide Baseline Characteristics

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.
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
Total Total of all reporting groups

Baseline Measures
   Aspirin Only   Vitamin E Only   Aspirin + Vitamin E   Both Placebos   Total 
Overall Participants Analyzed 
[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
  Show All Outcome Measures

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
  Hide Limitations and Caveats

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
No text entered.


  More Information
  Hide More Information

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:
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):


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: March 17, 2014