Statin Discontinuation in Advanced Illness

Completed · Not applicable

Conditions studied: Palliative Medicine, Cardiovascular Disease

In brief

The purpose of this study is to determine if there is a difference in survival rate at 60 days after enrollment between patients with advanced life-limiting illness for whom statins are discontinued vs. for patients with advanced life-limiting illness who are maintained on the medication. Secondary outcomes of this study will determine the effects of medication cessation on overall survival, important cardiovascular events, quality of life (QOL), symptoms, performance status, polypharmacy issues, satisfaction with care, and costs.

Key facts

Study ID

NCT01415934

Run by

University of Colorado, Denver

People needed

381

Starts

2011-06-03

Expected to finish

2013-07-15

Last updated by the study team

2018-09-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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.

Where it is running

• University of Alabama, Birmingham — Birmingham, Alabama, United States
• San Diego Hospice and the Institute for Palliative Medicine — San Diego, California, United States
• University of Colorado, Denver — Denver, Colorado, United States
• Kaiser Permanente — Denver, Colorado, United States
• Northwestern University — Chicago, Illinois, United States
• Mayo Clinic — Rochester, Minnesota, United States
• Washington University — St Louis, Missouri, United States
• Beth Israel Medical Center — New York, New York, United States
• Mount Sinai School of Medicine — New York, New York, United States
• University of North Carolina, Chapel Hill — Chapel Hill, North Carolina, United States
• Duke University Medical Center — Durham, North Carolina, United States
• Four Seasons Hospice and Palliative Care — Flat Rock, North Carolina, United States
• Hospice of Western Reserve — Cleveland, Ohio, United States
• Capital Caring — Falls Church, Virginia, United States
• University of Wisconsin Hospital and Clinics — Madison, Wisconsin, United States

Full record on ClinicalTrials.gov

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