Ignite Creation Date:
2025-12-25 @ 2:38 AM
Ignite Modification Date:
2025-12-30 @ 6:54 AM
Study NCT ID:
NCT01415934
Status:
COMPLETED
Last Update Posted:
2018-09-21
First Post:
2011-05-10
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Statin Discontinuation in Advanced Illness
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'CARRIE.BRILL@UCDENVER.EDU', 'phone': '303 808 9708', 'title': 'Carrie Brill', 'organization': 'University of Colorado'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '12 months', 'eventGroups': [{'id': 'EG000', 'title': 'Continue Statins', 'description': 'Participant will continue on statins as per usual', 'otherNumAtRisk': 192, 'deathsNumAtRisk': 192, 'otherNumAffected': 4, 'seriousNumAtRisk': 192, 'deathsNumAffected': 39, 'seriousNumAffected': 4}, {'id': 'EG001', 'title': 'Discontinue Statins', 'description': 'Participant will stop taking their statin drugs\n\ndiscontinue statins: patients will be randomized to either continue taking statins or discontinue.', 'otherNumAtRisk': 189, 'deathsNumAtRisk': 189, 'otherNumAffected': 7, 'seriousNumAtRisk': 189, 'deathsNumAffected': 45, 'seriousNumAffected': 6}], 'otherEvents': [{'term': 'Shortness of Breath', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 189, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Encephalpathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 189, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 189, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Fever', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 189, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 189, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 189, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 189, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Rehospitalization', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 189, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Psychological Distress', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 189, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Suicidal Ideation and severe depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 189, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Bowel Obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 189, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 189, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Chest Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 189, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 189, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Edema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 189, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Shortness of Breath', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 189, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Fever', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 189, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hip Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 189, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Low Blood Pressure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 189, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 189, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pulmonary Embolus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 189, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Rectal Bleed', 'stats': [{'groupId': 'EG000', 'numAtRisk': 192, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 189, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Proportion of Deaths Within 60 Days of Enrollment.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '192', 'groupId': 'OG000'}, {'value': '189', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Continue Statins', 'description': 'Patients in the continuation group continued to receive statins.'}, {'id': 'OG001', 'title': 'Discontinue Statins', 'description': 'Statin therapy was withdrawn from eligible patients who were randomized to the discontinuation group.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.203', 'groupId': 'OG000', 'lowerLimit': '0.156', 'upperLimit': '0.257'}, {'value': '0.238', 'groupId': 'OG001', 'lowerLimit': '0.188', 'upperLimit': '0.295'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Within 60 days of Subject Enrollment', 'description': '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.', 'unitOfMeasure': 'proportion of deaths', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to treat'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Continue Statins', 'description': 'Participant will continue on statins as per usual'}, {'id': 'FG001', 'title': 'Discontinue Statins', 'description': 'Participant will stop taking their statin drugs\n\ndiscontinue statins: patients will be randomized to either continue taking statins or discontinue.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '192'}, {'groupId': 'FG001', 'numSubjects': '189'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '189'}, {'groupId': 'FG001', 'numSubjects': '182'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '7'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '192', 'groupId': 'BG000'}, {'value': '189', 'groupId': 'BG001'}, {'value': '381', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Continue Statins', 'description': 'Patients in the continuation group continued to receive statins.'}, {'id': 'BG001', 'title': 'Discontinue Statins', 'description': 'Statin therapy was withdrawn from eligible patients who were randomized to the discontinuation group.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '38', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '73', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '154', 'groupId': 'BG000'}, {'value': '154', 'groupId': 'BG001'}, {'value': '308', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '73.5', 'spread': '11.5', 'groupId': 'BG000'}, {'value': '74.8', 'spread': '11.7', 'groupId': 'BG001'}, {'value': '74.1', 'spread': '11.6', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '80', 'groupId': 'BG000'}, {'value': '91', 'groupId': 'BG001'}, {'value': '171', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '112', 'groupId': 'BG000'}, {'value': '98', 'groupId': 'BG001'}, {'value': '210', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '182', 'groupId': 'BG000'}, {'value': '183', 'groupId': 'BG001'}, {'value': '365', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '54', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '162', 'groupId': 'BG000'}, {'value': '153', 'groupId': 'BG001'}, {'value': '315', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '192', 'groupId': 'BG000'}, {'value': '189', 'groupId': 'BG001'}, {'value': '381', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'This was a 15-site, parallel-group, unblinded, pragmatic clinical trial. Eligibility included adults with an estimated life expectancy of between 1 month and 1 year, statin therapy for 3 months or more for primary or secondary prevention of cardiovascular disease and no recent active cardiovascular disease.'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 381}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-06-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2013-07-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-08-22', 'studyFirstSubmitDate': '2011-05-10', 'resultsFirstSubmitDate': '2018-07-12', 'studyFirstSubmitQcDate': '2011-08-11', 'lastUpdatePostDateStruct': {'date': '2018-09-21', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-08-22', 'studyFirstPostDateStruct': {'date': '2011-08-12', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-09-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2013-07-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of Deaths Within 60 Days of Enrollment.', 'timeFrame': 'Within 60 days of Subject Enrollment', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Palliative Medicine', 'Cardiovascular Disease']}, 'referencesModule': {'references': [{'pmid': '26432571', 'type': 'BACKGROUND', 'citation': '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': '28520522', 'type': 'BACKGROUND', 'citation': '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': '28857119', 'type': 'BACKGROUND', 'citation': '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': '27663186', 'type': 'BACKGROUND', 'citation': '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': '25798575', 'type': 'RESULT', 'citation': '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': '37040386', 'type': 'DERIVED', 'citation': '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': '34433344', 'type': 'DERIVED', 'citation': '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': '34393192', 'type': 'DERIVED', 'citation': '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': '30719645', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': "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.\n\nThis 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age \\>18 years old;\n* have an advanced life-limiting illness;\n* 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;\n* be on a statin medication for primary or secondary prevention of cardiovascular disease for ≥3 months;\n* 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;\n* provide informed consent; and,\n* speak and read English at or above a grade 5 level (per patient or caregiver report).\n\nExclusion Criteria:\n\n* primary treating physician/care provider estimates their life expectancy as \\< 1 month;\n* under the care of a primary treating physician/primary care provider who is unwilling to have the patient enrolled;\n* not consenting;\n* 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,\n* 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.'}, 'identificationModule': {'nctId': 'NCT01415934', 'briefTitle': 'Statin Discontinuation in Advanced Illness', 'organization': {'class': 'OTHER', 'fullName': 'University of Colorado, Denver'}, 'officialTitle': 'Multisite Randomized Controlled Trial of Continuing vs. Discontinuing Statins', 'orgStudyIdInfo': {'id': '11-0314'}, 'secondaryIdInfos': [{'id': 'UC4NR012584', 'link': 'https://reporter.nih.gov/quickSearch/UC4NR012584', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Continue Statins', 'description': 'Participant will continue on statins as per usual'}, {'type': 'EXPERIMENTAL', 'label': 'Discontinue statins', 'description': 'Participant will stop taking their statin drugs', 'interventionNames': ['Other: discontinue statins']}], 'interventions': [{'name': 'discontinue statins', 'type': 'OTHER', 'description': 'patients will be randomized to either continue taking statins or discontinue.', 'armGroupLabels': ['Discontinue statins']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35294', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of Alabama, Birmingham', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '92103', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'San Diego Hospice and the Institute for Palliative Medicine', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '80217', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'University of Colorado, Denver', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '80231', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'Kaiser Permanente', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Northwestern University', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}, {'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Washington University', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '10003', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Beth Israel Medical Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10029', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Mount Sinai School of Medicine', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '27599', 'city': 'Chapel Hill', 'state': 'North Carolina', 'country': 'United States', 'facility': 'University of North Carolina, Chapel Hill', 'geoPoint': {'lat': 35.9132, 'lon': -79.05584}}, {'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke University Medical Center', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '28731', 'city': 'Flat Rock', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Four Seasons Hospice and Palliative Care', 'geoPoint': {'lat': 35.27123, 'lon': -82.44151}}, {'zip': '44106', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Hospice of Western Reserve', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '22042', 'city': 'Falls Church', 'state': 'Virginia', 'country': 'United States', 'facility': 'Capital Caring', 'geoPoint': {'lat': 38.88233, 'lon': -77.17109}}, {'zip': '53792', 'city': 'Madison', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'University of Wisconsin Hospital and Clinics', 'geoPoint': {'lat': 43.07305, 'lon': -89.40123}}], 'overallOfficials': [{'name': 'Amy Abernethy, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Duke University'}, {'name': 'Jean Kutner, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Colorado, Denver'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Colorado, Denver', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Nursing Research (NINR)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}