N/A
N=381
Statin Discontinuation in Advanced Illness
Palliative Medicine · Cardiovascular Disease
Bottom Line
View on ClinicalTrials.gov: NCT01415934 ↗Enrolled (actual)
381
Serious AEs
2.6%
Results posted
Sep 2018
Primary outcome: Primary: Proportion of Deaths Within 60 Days of Enrollment. — 0.203; 0.238 proportion of deaths
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- discontinue statins (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Colorado, Denver
- Primary completion
- Jul 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Proportion of Deaths Within 60 Days of Enrollment. |
0.203; 0.238 | — |
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 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.
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 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.
Data sourced from ClinicalTrials.gov (NCT01415934). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.