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:
2025-12-25 @ 2:38 AM
Ignite Modification Date:
2025-12-25 @ 2:38 AM
NCT ID:
NCT01415934
Eligibility Criteria:
Inclusion Criteria:
* age \>18 years old;
* have an advanced life-limiting illness;
* have a life expectancy of \>1 month, AND patient exhibits declining functional status, defined as a reduction in Australia-modified Karnofsky Performance Status (AKPS)22 score to \<80% in the previous 3 months;
* be on a statin medication for primary or secondary prevention of cardiovascular disease for ≥3 months;
* have adequately intact cognitive status to provide informed consent and complete the baseline assessment, as evidenced by a Short Portable Mental Status Questionnaire (SPMSQ)23 score of ≥6;
* provide informed consent; and,
* speak and read English at or above a grade 5 level (per patient or caregiver report).
Exclusion Criteria:
* primary treating physician/care provider estimates their life expectancy as \< 1 month;
* under the care of a primary treating physician/primary care provider who is unwilling to have the patient enrolled;
* not consenting;
* having known active cardiovascular disease or sufficient risk of active cardiovascular disease to require ongoing therapy with statin drugs, in the opinion of the treating physician; OR,
* exhibiting obvious symptoms of myositis, known liver function test (LFT) abnormalities of \>2.5x the upper limit of normal (ULN), known creatine kinase (CK) abnormalities of \>2.5x ULN, or other contraindications to continuing statins, in the opinion of the treating physician.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01415934
Study Brief:
Protocol Section:
NCT01415934