Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 12:44 PM
Ignite Modification Date:
2025-12-24 @ 12:44 PM
NCT ID:
NCT00000161
Eligibility Criteria:
Women's Health Study:
A participant must have met all of the following criteria:
(a) female; (b) aged 45 years or older; (c) postmenopausal or with no intention of becoming pregnant; (d) no reported personal history of cardiovascular disease, cancer (other than non-melanoma skin cancer), gout, peptic ulcer, chronic renal or liver disease, or other serious illness precluding participation; (e) no reported history of serious side effects to the study treatments; (f) not currently taking aspirin, aspirin containing medication, or nonsteroidal anti-inflammatory drugs (NSAIDs) more than 1 day per week or, if so doing, willing to forego use of these medications; (g) not currently taking individual supplements of vitamin E or beta carotene more than 1 day per week; (h) not currently taking anticoagulants or corticosteroids.
Women's Antioxidant Cardiovascular Study:
Potentially eligible female health professionals for WACS were identified from the pool of respondents to the Women's Health Study initial mailing and must have met the following criteria:
(a) female; (b) date of birth before January 1, 1955; (c) a reported history of myocardial infarction (MI), stroke (CVA), angina pectoris (AP), coronary artery bypass grafting (CABG), percutaneous transluminal angioplasty (PCTA), transient ischemic attack (TIA), carotid endarterectomy (CEA), or peripheral artery surgery (PAS); (d) no history of cancer (except non-melanoma skin cancer) within the past 10 years and no active liver disease or cirrhosis; (e) pregnancy physiologically impossible due to menopause (natural or surgical) or tubal ligation, or the participant does not intend to become pregnant in the future as indicated on the initial WHS questionnaire; (f) no current use of a vitamin K-depleting anticoagulant agent (e.g., Coumadin). Individuals taking aspirin or other NSAIDs were not excluded.
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
45 Years
Study:
NCT00000161
Study Brief:
Protocol Section:
NCT00000161