NCT00000479: WHS

Women's Health Study of Low-dose Aspirin and Vitamin E in Apparently Healthy Women

Completed Phase 3 Results posted Last updated 12 June 2012

What this trial tests

Phase 3 trial testing Aspirin in Cardiovascular Diseases in 39,876 participants. Completed in 1 February 2005.

Timeline

1 September 1992

Primary endpoint
1 March 2004

1 February 2005

Quick facts

Lead sponsor	Brigham and Women's Hospital
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	factorial
Masking	triple
Primary purpose	prevention
Enrollment	39,876
Start date	1 September 1992
Primary completion	1 March 2004
Estimated completion	1 February 2005

Drugs / interventions tested

• Aspirin — full drug profile →
• Vitamin E (VITAMIN E) — full drug profile →
• Placebo

Conditions studied

• Cardiovascular Diseases — all drugs for Cardiovascular Diseases →
• Cerebrovascular Disorders — all drugs for Cerebrovascular Disorders →
• Coronary Disease — all drugs for Coronary Disease →
• Heart Diseases — all drugs for Heart Diseases →

Sponsor

Brigham and Women's Hospital

Who can join

45 and older, female only, with Cardiovascular Diseases or Cerebrovascular Disorders. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• 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
• Number of Participants With Cancer, Excluding Nonmelanoma Skin Cancer
  Time frame: Average follow-up 10.1 years

Sponsor's own description

The purpose of this study is to evaluate the effects of low-dose aspirin and vitamin E in primary prevention of cardiovascular disease and cancer in apparently healthy women.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. The long- and short-term impact of elevated body mass index on the risk of new atrial fibrillation the WHS (women's health study).
   Tedrow UB, Conen D, Ridker PM, Cook NR, et al · · 2010 · cited 372× · PMID 20488302 · DOI 10.1016/j.jacc.2010.02.029
2. Triglyceride-Rich Lipoprotein Cholesterol, Small Dense LDL Cholesterol, and Incident Cardiovascular Disease.
   Duran EK, Aday AW, Cook NR, Buring JE, et al · · 2020 · cited 253× · PMID 32354380 · DOI 10.1016/j.jacc.2020.02.059
3. Influence of systolic and diastolic blood pressure on the risk of incident atrial fibrillation in women.
   Conen D, Tedrow UB, Koplan BA, Glynn RJ, et al · · 2009 · cited 240× · PMID 19364977 · DOI 10.1161/circulationaha.108.830042
4. Alternate-day, low-dose aspirin and cancer risk: long-term observational follow-up of a randomized trial.
   Cook NR, Lee IM, Zhang SM, Moorthy MV, et al · · 2013 · cited 227× · PMID 23856681 · DOI 10.7326/0003-4819-159-2-201307160-00002
5. Discordance of low-density lipoprotein (LDL) cholesterol with alternative LDL-related measures and future coronary events.
   Mora S, Buring JE, Ridker PM. · · 2014 · cited 186× · PMID 24345402 · DOI 10.1161/circulationaha.113.005873
6. A novel protein glycan biomarker and future cardiovascular disease events.
   Akinkuolie AO, Buring JE, Ridker PM, Mora S. · · 2014 · cited 178× · PMID 25249300 · DOI 10.1161/jaha.114.001221
7. Circulating Branched-Chain Amino Acids and Incident Cardiovascular Disease in a Prospective Cohort of US Women.
   Tobias DK, Lawler PR, Harada PH, Demler OV, et al · · 2018 · cited 174× · PMID 29572205 · DOI 10.1161/circgen.118.002157
8. Migraine, vascular risk, and cardiovascular events in women: prospective cohort study.
   Kurth T, Schürks M, Logroscino G, Gaziano JM, et al · · 2008 · cited 174× · PMID 18687721 · DOI 10.1136/bmj.a636