NCT01415934

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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
381

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2011

Typical duration for not_applicable

Geographic Reach
1 country

15 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 10, 2011

Completed
24 days until next milestone

Study Start

First participant enrolled

June 3, 2011

Completed
2 months until next milestone

First Posted

Study publicly available on registry

August 12, 2011

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2013

Completed
5.2 years until next milestone

Results Posted

Study results publicly available

September 21, 2018

Completed
Last Updated

September 21, 2018

Status Verified

August 1, 2018

Enrollment Period

2.1 years

First QC Date

May 10, 2011

Results QC Date

July 12, 2018

Last Update Submit

August 22, 2018

Conditions

Palliative MedicineCardiovascular Disease

Outcome Measures

Primary Outcomes (1)

  • 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.

    Within 60 days of Subject Enrollment

Study Arms (2)

Continue Statins

NO INTERVENTION

Participant will continue on statins as per usual

Discontinue statins

EXPERIMENTAL

Participant will stop taking their statin drugs

Other: discontinue statins

Interventions

discontinue statinsOTHER

patients will be randomized to either continue taking statins or discontinue.

Discontinue statins

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (15)

University of Alabama, Birmingham

Birmingham, Alabama, 35294, United States

Location

San Diego Hospice and the Institute for Palliative Medicine

San Diego, California, 92103, United States

Location

University of Colorado, Denver

Denver, Colorado, 80217, United States

Location

Kaiser Permanente

Denver, Colorado, 80231, United States

Location

Northwestern University

Chicago, Illinois, 60611, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Washington University

St Louis, Missouri, 63110, United States

Location

Beth Israel Medical Center

New York, New York, 10003, United States

Location

Mount Sinai School of Medicine

New York, New York, 10029, United States

Location

University of North Carolina, Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Four Seasons Hospice and Palliative Care

Flat Rock, North Carolina, 28731, United States

Location

Hospice of Western Reserve

Cleveland, Ohio, 44106, United States

Location

Capital Caring

Falls Church, Virginia, 22042, United States

Location

University of Wisconsin Hospital and Clinics

Madison, Wisconsin, 53792, United States

Location

Related Publications (9)

  • 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.

    PMID: 26432571BACKGROUND

  • Tjia 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.

    PMID: 28520522BACKGROUND

  • Portz 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.

    PMID: 28857119BACKGROUND

  • Hochman 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.

    PMID: 27663186BACKGROUND

  • Kutner 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.

    PMID: 25798575RESULT

  • Murali 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.

    PMID: 37040386DERIVED

  • Murali 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.

    PMID: 34433344DERIVED

  • Murali 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.

    PMID: 34393192DERIVED

  • Schenker 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.

    PMID: 30719645DERIVED

MeSH Terms

Conditions

Cardiovascular Diseases

Results Point of Contact

Title
Carrie Brill
Organization
University of Colorado
CARRIE.BRILL@UCDENVER.EDU
303 808 9708

Study Officials

  • Amy Abernethy, MD

    Duke University

    PRINCIPAL INVESTIGATOR

  • Jean Kutner, MD

    University of Colorado, Denver

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 10, 2011

First Posted

August 12, 2011

Study Start

June 3, 2011

Primary Completion

July 15, 2013

Study Completion

July 15, 2013

Last Updated

September 21, 2018

Results First Posted

September 21, 2018

Record last verified: 2018-08

Data Sharing

IPD Sharing
Will not share

Locations

US(15)