Status:
COMPLETED
Statin Discontinuation in Advanced Illness
Lead Sponsor:
University of Colorado, Denver
Collaborating Sponsors:
National Institute of Nursing Research (NINR)
Conditions:
Palliative Medicine
Cardiovascular Disease
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 v...
Detailed Description
Currently, over 80% of the population is expected to die of chronic life-limiting illnesses, predominant among which are the various manifestations of cardiovascular disease, cancer, dementia, and chr...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 3 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 15 2013
Estimated Enrollment :
381 Patients enrolled
Trial Details
Trial ID
NCT01415934
Start Date
June 3 2011
End Date
July 15 2013
Last Update
September 21 2018
Active Locations (15)
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1
University of Alabama, Birmingham
Birmingham, Alabama, United States, 35294
2
San Diego Hospice and the Institute for Palliative Medicine
San Diego, California, United States, 92103
3
University of Colorado, Denver
Denver, Colorado, United States, 80217
4
Kaiser Permanente
Denver, Colorado, United States, 80231