Palliative MedicineNCT01415934
Statin Discontinuation in Advanced Illness
A study testing discontinue statins in people with Palliative Medicine and Cardiovascular Disease, run by University of Colorado, Denver at 15 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Palliative Medicine, Cardiovascular Disease
- What is being tested?
- discontinue statins
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 381 participants
- Where
- 15 sitesUnited States
- Study dates
- 3 Jun 2011to 15 Jul 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
United States15 sites
University of Alabama, Birmingham
Birmingham, Alabama, 35294
University of North Carolina, Chapel Hill
Chapel Hill, North Carolina, 27599
Northwestern University
Chicago, Illinois, 60611
Hospice of Western Reserve
Cleveland, Ohio, 44106
University of Colorado, Denver
Denver, Colorado, 80217
Kaiser Permanente
Denver, Colorado, 80231
Duke University Medical Center
Durham, North Carolina, 27710
Capital Caring
Falls Church, Virginia, 22042
Four Seasons Hospice and Palliative Care
Flat Rock, North Carolina, 28731
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, 53792
Beth Israel Medical Center
New York, New York, 10003
Mount Sinai School of Medicine
New York, New York, 10029
Mayo Clinic
Rochester, Minnesota, 55905
San Diego Hospice and the Institute for Palliative Medicine
San Diego, California, 92103
Washington University
St Louis, Missouri, 63110
About this study
Official title: Multisite Randomized Controlled Trial of Continuing vs. Discontinuing Statins
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.
Read the 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 chronic lung disease. Patients with high cholesterol and those potentially at risk for atherosclerotic heart disease and stroke are often treated preventively with HMG Co-A reductase inhibitors (a.k.a., statins). Clinical trial evidence supports the use of statins for patients with hyperlipidemia and established ischemic heart disease to reduce risk of future cardiovascular events and mortality, and to reduce risk of future cardiovascular events in patients with multiple cardiac risk factors. Beneficial outcomes are evident in these trials after 3-6 years of treatment. Hence, statins are among the most prescribed medications in the world. In the United States, over 25% of Medicare beneficiaries take a statin medication. Statin medications are frequently continued until the patient can no longer eat or swallow at the end of life, because there are no evidence-based guidelines regarding when or how to discontinue medications for co-morbidities. The risks and costs vs. benefits of statins for palliative care patients, for whom prognosis is limited, remains a genuine clinical uncertainty. Meanwhile, medications for symptoms and other concerns accumulate as illness progresses, and therefore polypharmacy and compounding medication side effects are troublesome problems in the setting of advanced life-limiting illness. While multiple studies have demonstrated the benefit of long-term preventive statin use for patients at cardiovascular risk, other studies have supported the discontinuation of medications (specifically statins) in end-stage disease. A rational approach to medication discontinuation, specifically statin discontinuation, therefore has the potential to reduce patient burden, polypharmacy, and side effects, while also preserving healthcare resources for more beneficial interventions.
This study is a multi-site randomized controlled trial of discontinuing vs. continuing statin medications in patients with advanced life-limiting illness. Eligible participants are adults with advanced life-limiting illness with an estimated prognosis of 1-6 months who are on statins for primary or secondary prevention of cardiovascular events. The primary outcome is survival rate at 60 days; secondary outcomes address cardiovascular events, polypharmacy, medication adverse effects, quality of life (QOL), and measures of the patient's health-related experience. The primary hypothesis is that discontinuing statins will not influence survival. Secondary hypotheses are that discontinuation of statins will not adversely affect cardiovascular events or overall QOL, but will improve statin-related symptoms and decrease polypharmacy.
- Conditions
- Palliative Medicine, Cardiovascular Disease
- Being tested
- discontinue statins
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
discontinue statinsOther
patients will be randomized to either continue taking statins or discontinue.
| Study group | Role | What they receive |
|---|---|---|
| Continue Statins | No intervention | Participant will continue on statins as per usual |
| Discontinue statins | Experimental | Participant will stop taking their statin drugs Receives: Other: discontinue statins |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Deaths Within 60 Days of Enrollment.
To determine, among patients with life-limiting illness, if there is a difference in the proportion who die within 60 days after enrollment between patients for whom statins are discontinued vs. patients who are maintained on the medication.
Measured: Within 60 days of Subject Enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2011 (estimated)
- Study start3 Jun 2011
- Primary completion15 Jul 2013
- Study completion15 Jul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Palliative MedicineStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 381 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Responsible party
- Sponsor
- Investigators
- Amy Abernethy, MD, Principal investigator, Duke UniversityJean Kutner, MD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01415934
- Sponsor's protocol ID
- 11-0314
- Other IDs
- UC4NR012584
- Status last verified
- Aug 2018
- First submitted
- 10 May 2011
- Last updated
- 21 Sep 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
McNeil MJ, Kamal AH, Kutner JS, Ritchie CS, Abernethy AP. The Burden of Polypharmacy in Patients Near the End of Life. J Pain Symptom Manage. 2016 Feb;51(2):178-83.e2. doi: 10.1016/j.jpainsymman.2015.09.003. Epub 2015 Sep 30.
PubMed 26432571Tjia J, Kutner JS, Ritchie CS, Blatchford PJ, Bennett Kendrick RE, Prince-Paul M, Somers TJ, McPherson ML, Sloan JA, Abernethy AP, Furuno JP. Perceptions of Statin Discontinuation among Patients with Life-Limiting Illness. J Palliat Med. 2017 Oct;20(10):1098-1103. doi: 10.1089/jpm.2016.0489. Epub 2017 May 18.
PubMed 28520522Portz JD, Kutner JS, Blatchford PJ, Ritchie CS. High Symptom Burden and Low Functional Status in the Setting of Multimorbidity. J Am Geriatr Soc. 2017 Oct;65(10):2285-2289. doi: 10.1111/jgs.15045. Epub 2017 Aug 30.
PubMed 28857119Hochman MJ, Kamal AH, Wolf SP, Samsa GP, Currow DC, Abernethy AP, LeBlanc TW. Anticholinergic Drug Burden in Noncancer Versus Cancer Patients Near the End of Life. J Pain Symptom Manage. 2016 Nov;52(5):737-743.e3. doi: 10.1016/j.jpainsymman.2016.03.020. Epub 2016 Sep 20.
PubMed 27663186Kutner JS, Blatchford PJ, Taylor DH Jr, Ritchie CS, Bull JH, Fairclough DL, Hanson LC, LeBlanc TW, Samsa GP, Wolf S, Aziz NM, Currow DC, Ferrell B, Wagner-Johnston N, Zafar SY, Cleary JF, Dev S, Goode PS, Kamal AH, Kassner C, Kvale EA, McCallum JG, Ogunseitan AB, Pantilat SZ, Portenoy RK, Prince-Paul M, Sloan JA, Swetz KM, Von Gunten CF, Abernethy AP. Safety and benefit of discontinuing statin therapy in the setting of advanced, life-limiting illness: a randomized clinical trial. JAMA Intern Med. 2015 May;175(5):691-700. doi: 10.1001/jamainternmed.2015.0289.
PubMed 25798575Murali KP, Merriman JD, Yu G, Vorderstrasse A, Kelley AS, Brody AA. Complex Care Needs at the End of Life for Seriously Ill Adults With Multiple Chronic Conditions. J Hosp Palliat Nurs. 2023 Jun 1;25(3):146-155. doi: 10.1097/NJH.0000000000000946. Epub 2023 Apr 11.
PubMed 37040386Murali KP, Yu G, Merriman JD, Vorderstrasse A, Kelley AS, Brody AA. Multiple Chronic Conditions among Seriously Ill Adults Receiving Palliative Care. West J Nurs Res. 2023 Jan;45(1):14-24. doi: 10.1177/01939459211041174. Epub 2021 Aug 25.
PubMed 34433344Murali KP, Yu G, Merriman JD, Vorderstrasse A, Kelley AS, Brody AA. Latent Class Analysis of Symptom Burden Among Seriously Ill Adults at the End of Life. Nurs Res. 2021 Nov-Dec 01;70(6):443-454. doi: 10.1097/NNR.0000000000000549.
PubMed 34393192Schenker Y, Park SY, Jeong K, Pruskowski J, Kavalieratos D, Resick J, Abernethy A, Kutner JS. Associations Between Polypharmacy, Symptom Burden, and Quality of Life in Patients with Advanced, Life-Limiting Illness. J Gen Intern Med. 2019 Apr;34(4):559-566. doi: 10.1007/s11606-019-04837-7. Epub 2019 Feb 4.
PubMed 30719645
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multisite Randomized Controlled Trial of Continuing vs. Discontinuing Statins
- ClinicalTrials.gov ID
- NCT01415934
- Acronym / sponsor ID
- 11-0314
- Conditions
- Palliative Medicine, Cardiovascular Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 381 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Study start
- 3 Jun 2011 (actual)
- Primary completion
- 15 Jul 2013 (actual)
- Study completion
- 15 Jul 2013 (actual)
- First posted
- 12 Aug 2011 (estimated)
- Results
- Posted 21 Sep 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 chronic lung disease. Patients with high cholesterol and those potentially at risk for atherosclerotic heart disease and stroke are often treated preventively with HMG Co-A reductase inhibitors (a.k.a., statins). Clinical trial evidence supports the use of statins for patients with hyperlipidemia and established ischemic heart disease to reduce risk of future cardiovascular events and mortality, and to reduce risk of future cardiovascular events in patients with multiple cardiac risk factors. Beneficial outcomes are evident in these trials after 3-6 years of treatment. Hence, statins are among the most prescribed medications in the world. In the United States, over 25% of Medicare beneficiaries take a statin medication. Statin medications are frequently continued until the patient can no longer eat or swallow at the end of life, because there are no evidence-based guidelines regarding when or how to discontinue medications for co-morbidities. The risks and costs vs. benefits of statins for palliative care patients, for whom prognosis is limited, remains a genuine clinical uncertainty. Meanwhile, medications for symptoms and other concerns accumulate as illness progresses, and therefore polypharmacy and compounding medication side effects are troublesome problems in the setting of advanced life-limiting illness. While multiple studies have demonstrated the benefit of long-term preventive statin use for patients at cardiovascular risk, other studies have supported the discontinuation of medications (specifically statins) in end-stage disease. A rational approach to medication discontinuation, specifically statin discontinuation, therefore has the potential to reduce patient burden, polypharmacy, and side effects, while also preserving healthcare resources for more beneficial interventions.
This study is a multi-site randomized controlled trial of discontinuing vs. continuing statin medications in patients with advanced life-limiting illness. Eligible participants are adults with advanced life-limiting illness with an estimated prognosis of 1-6 months who are on statins for primary or secondary prevention of cardiovascular events. The primary outcome is survival rate at 60 days; secondary outcomes address cardiovascular events, polypharmacy, medication adverse effects, quality of life (QOL), and measures of the patient's health-related experience. The primary hypothesis is that discontinuing statins will not influence survival. Secondary hypotheses are that discontinuation of statins will not adversely affect cardiovascular events or overall QOL, but will improve statin-related symptoms and decrease polypharmacy.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Continue Statins | No intervention | –Participant will continue on statins as per usual |
| Discontinue statins | Experimental | Other: discontinue statinsParticipant will stop taking their statin drugs |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| discontinue statinspatients will be randomized to either continue taking statins or discontinue. | Other | Discontinue statins |
Primary outcome
Proportion of Deaths Within 60 Days of Enrollment.
Time frame: Within 60 days of Subject Enrollment
To determine, among patients with life-limiting illness, if there is a difference in the proportion who die within 60 days after enrollment between patients for whom statins are discontinued vs. patients who are maintained on the medication.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 26432571McNeil MJ, Kamal AH, Kutner JS, Ritchie CS, Abernethy AP. The Burden of Polypharmacy in Patients Near the End of Life. J Pain Symptom Manage. 2016 Feb;51(2):178-83.e2. doi: 10.1016/j.jpainsymman.2015.09.003. Epub 2015 Sep 30.
- Background: PubMed 28520522Tjia J, Kutner JS, Ritchie CS, Blatchford PJ, Bennett Kendrick RE, Prince-Paul M, Somers TJ, McPherson ML, Sloan JA, Abernethy AP, Furuno JP. Perceptions of Statin Discontinuation among Patients with Life-Limiting Illness. J Palliat Med. 2017 Oct;20(10):1098-1103. doi: 10.1089/jpm.2016.0489. Epub 2017 May 18.
- Background: PubMed 28857119Portz JD, Kutner JS, Blatchford PJ, Ritchie CS. High Symptom Burden and Low Functional Status in the Setting of Multimorbidity. J Am Geriatr Soc. 2017 Oct;65(10):2285-2289. doi: 10.1111/jgs.15045. Epub 2017 Aug 30.
- Background: PubMed 27663186Hochman MJ, Kamal AH, Wolf SP, Samsa GP, Currow DC, Abernethy AP, LeBlanc TW. Anticholinergic Drug Burden in Noncancer Versus Cancer Patients Near the End of Life. J Pain Symptom Manage. 2016 Nov;52(5):737-743.e3. doi: 10.1016/j.jpainsymman.2016.03.020. Epub 2016 Sep 20.
- Results publication: PubMed 25798575Kutner JS, Blatchford PJ, Taylor DH Jr, Ritchie CS, Bull JH, Fairclough DL, Hanson LC, LeBlanc TW, Samsa GP, Wolf S, Aziz NM, Currow DC, Ferrell B, Wagner-Johnston N, Zafar SY, Cleary JF, Dev S, Goode PS, Kamal AH, Kassner C, Kvale EA, McCallum JG, Ogunseitan AB, Pantilat SZ, Portenoy RK, Prince-Paul M, Sloan JA, Swetz KM, Von Gunten CF, Abernethy AP. Safety and benefit of discontinuing statin therapy in the setting of advanced, life-limiting illness: a randomized clinical trial. JAMA Intern Med. 2015 May;175(5):691-700. doi: 10.1001/jamainternmed.2015.0289.
- Derived from this study: PubMed 37040386Murali KP, Merriman JD, Yu G, Vorderstrasse A, Kelley AS, Brody AA. Complex Care Needs at the End of Life for Seriously Ill Adults With Multiple Chronic Conditions. J Hosp Palliat Nurs. 2023 Jun 1;25(3):146-155. doi: 10.1097/NJH.0000000000000946. Epub 2023 Apr 11.
- Derived from this study: PubMed 34433344Murali KP, Yu G, Merriman JD, Vorderstrasse A, Kelley AS, Brody AA. Multiple Chronic Conditions among Seriously Ill Adults Receiving Palliative Care. West J Nurs Res. 2023 Jan;45(1):14-24. doi: 10.1177/01939459211041174. Epub 2021 Aug 25.
- Derived from this study: PubMed 34393192Murali KP, Yu G, Merriman JD, Vorderstrasse A, Kelley AS, Brody AA. Latent Class Analysis of Symptom Burden Among Seriously Ill Adults at the End of Life. Nurs Res. 2021 Nov-Dec 01;70(6):443-454. doi: 10.1097/NNR.0000000000000549.
- Derived from this study: PubMed 30719645Schenker Y, Park SY, Jeong K, Pruskowski J, Kavalieratos D, Resick J, Abernethy A, Kutner JS. Associations Between Polypharmacy, Symptom Burden, and Quality of Life in Patients with Advanced, Life-Limiting Illness. J Gen Intern Med. 2019 Apr;34(4):559-566. doi: 10.1007/s11606-019-04837-7. Epub 2019 Feb 4.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amy Abernethy, MD principal investigator
Duke University
Jean Kutner, MD principal investigator
University of Colorado, Denver
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing discontinue statins in people with Palliative Medicine and Cardiovascular Disease, run by University of Colorado, Denver at 15 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Sep 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Deaths Within 60 Days of Enrollment. (time frame: Within 60 days of Subject Enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01415934, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2018.