Atheroscleroses, CoronaryPhase 4NCT04826354
Effects of Statin for Elderly Patients With Atherosclerotic Cardiovascular Disease
A Phase 4 study testing Rosuvastatin and Ezetimibe and Rosuvastatin in people with Atheroscleroses, Coronary, run by Korea University Anam Hospital at 2 sites in South Korea.
Trial summary
High-dose statins can reduce mortality and cardiovascular events in patients with established atherosclerotic cardiovascular disease (ASCVD). Therefore, US and European recommendations recommend that established ASCVD patients (coronary artery disease, cerebrovascular disease, peripheral vascular disease) use… Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Atheroscleroses, Coronary
- What is being tested?
- Rosuvastatin and Ezetimibe and Rosuvastatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 582 participants
- Where
- 2 sitesSouth Korea
- Study dates
- 11 Aug 2021to 28 Jun 2023
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
None listed.
Who cannot join
- Take statins or ezetimibe within the last 4 weeks
- In case of end-stage kidney disease (eGFR<30 ml/min/1.73m2)
- Heart surgery or major surgery is planned within the next 6 months
- Patients with chronic diseases such as severe lung disease, stroke, etc.
- Patients with chronic inflammatory diseases who require oral, intravenous, or intra-articular steroid treatment (Ointments, inhalants, or intranasal steroids are allowed)
- If you have been diagnosed with cancer within the past 1 year or are currently receiving chemotherapy
Show all 10Show fewer
- In the case of clinically significant abnormal findings that may infringe on the safety of the study by the investigator's judgment confirmed in a screening visit, physical examination, blood test, or electrocardiogram
- Liver disease, bile duct obstruction, or liver enzyme level (ALT/AST) is more than 3 times normal
- If you have a disease whose life expectancy is less than 1 year
- If you do not want or cannot comply with the procedure described in the research proposal
Trial locations and contacts
2 sites in 1 country.
South Korea2 sites
Kangbuk Samsung Hospital
Seoul
Korea University Anam Hospital
Seoul
About this study
Official title: Effects of High-dose StAtin Versus Low-dose Statin Plus Ezetimibe on Statin-Associated Muscle Symptoms & on Reaching Target LDL-C Levels Among Elderly Patients With Atherosclerotic Cardiovascular Disease
High-dose statins can reduce mortality and cardiovascular events in patients with established atherosclerotic cardiovascular disease (ASCVD). Therefore, US and European recommendations recommend that established ASCVD patients (coronary artery disease, cerebrovascular disease, peripheral vascular disease) use high-dose statins to lower LDL cholesterol levels by at least 50%. However, in actual practice, high-dose statins are relatively less used, and the reason is unclear, but it is believed to be due to concerns about the side effects of high-dose statins. Most of the side effects of statins are statin-associated muscle symptoms (SAMS), which are more common than the incidence in clinical studies, especially in frontline care. These muscle side effects are dose-dependent and are common at high doses, and the incidence is known to increase in the elderly over 70 years of age. However, the US recommendation recommends using high-dose statins to lower LDL cholesterol by 50% or more to prevent cardiovascular events even in ASCVD patients over 70 years of age.
Most early studies on lowering LDL cholesterol in ASCVD patients used high doses of statins. However, after introducing cholesterol absorption inhibitors ezetimibe and PCSK9 inhibitor, large-scale clinical studies have been conducted to lower LDL cholesterol using these drugs. In this study, as in the statin study, cardiovascular events were significantly reduced, and together with statins, it became a standard treatment for ASCVD patients. On the other hand, the clinical benefit shown in clinical studies using cholesterol-lowering agents so far depends entirely on how much LDL cholesterol is lowered and how long it is maintained in a low state, indicating that LDL cholesterol management is the core of arteriosclerosis treatment. In addition to high-dose statins, a combination of low-dose statins and ezetimibe can be cited as a method for lowering LDL cholesterol to more than 50%. In the latter case, it is expected that there will be an advantage of reducing muscle side effects by reaching the target LDL cholesterol level by using a low-dose statin. However, no studies compare the difference in muscle side effects between low-dose statins and ezetimibe combination drugs, which reduce LDL cholesterol to the same extent compared to high-dose statins, in elderly patients over 70 years of age with ASCVD. In this study, the association of low-dose rosuvastatin 5mg and ezetimibe combination (rosuvastatin 10/5mg) compared to high-dose rosuvastatin 20mg in elderly patients 70 years of age or older with established ASCVD. This study aims to compare and analyze the incidence of muscle symptoms (SAMS) and their effect on LDL cholesterol.
Read the detailed description
Established Atherosclerotic Cardiovascular Disease (ASCVD)
- Coronary artery disease meeting at least one of the following criteria:
- A history of coronary recanalization in multivessel coronary artery disease, evidenced by any of the following:
- Percutaneous coronary intervention (PCI) of one or more vessels, including branching arteries
- PCI or coronary artery bypass grafting (CABG) for >50% residual stenosis in separate vessels that have not undergone recanalization
- multivessel CABG at least 5 years prior to screening
- Significant coronary without prior revascularization, evidenced by >70% stenosis in at least one coronary artery, >50% stenosis in two or more coronary arteries, or >50% stenosis in the left main coronary artery arterial disease
- Known coronary calcium score > 100 in subjects who did not undergo coronary recanalization prior to randomization
- Cerebrovascular Disease meeting at least one of the following criteria:
- Previous transient ischemic attack with carotid artery stenosis in 50%
- 70% internal or external carotid artery stenosis or >50% stenosis of two or more
- Past history of recanalization of internal or external carotid artery
- Peripheral arterial disease meeting at least one of the following criteria:
- > 50% stenosis in the arteries of the extremities
- History of abdominal aortic treatment (percutaneous or surgical) for atherosclerotic disease
- Ankle Brachial Index (ABI) ≤ 0.90
- Conditions
- Atheroscleroses, Coronary
- Being tested
- Rosuvastatin and Ezetimibe, Rosuvastatin
- Keywords
- Elderly, Statin, Ezetimibe
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rosuvastatin and EzetimibeDrug
Rosuvastatin Versus Rosuvastatin plus Ezetimibe
RosuvastatinDrug
Rosuvastatin
| Study group | Role | What they receive |
|---|---|---|
| Rosuvastatin | Experimental | Rosuvastatin 20mg Receives: Drug: Rosuvastatin |
| Rosuvamibe | Active comparator | Rosuvastatin plus ezetimibe 10/5 Receives: Drug: Rosuvastatin and Ezetimibe |
What is being measured
The primary outcome is the main question the study is designed to answer.
Statin-Associated Muscle Symptoms (SAMS)
Patients with a Proposed Statin Myalgia Index score of 7 or higher (Cardiovasc Drugs Ther 2003;17:459-465):
- Aspects: muscle pain, muscle spasms, muscle stiffness, feeling of strength, ligament pain, etc.
- Location: thigh, buttocks, calves, back muscle, proximal arms
- Onset time after dosing: within 6 months
- Deteriorating factors: exercise, rest, cold exposure, position change, fasting
- Severe: Occurs in abnormalities in daily life, occurs in daily life, occurs in less than daily life
Measured: 6 month
Target Low density lipoprotein cholesterol (LDL-C) achievement
Target LDL-C achievement (LDL <70mg/dL)
Measured: 6 month
Secondary outcomes (9)
CK levels
Creatinine Kinase levels
Measured: 6 month
GOT levels
Aspartate Transaminase (Glutamic Oxaloacetic Transaminase levels
Measured: 6 month
GPT levels
Alanine Transaminase (Glutamic Pyruvic Transaminase) levels
Measured: 6 month
Levels of Total cholesterol, LDL cholesterol, HDL cholesterol
Levels of Total cholesterol, LDL cholesterol, HDL cholesterol
Measured: 6 month
Level of Triglyceride
Level of Triglyceride
Measured: 6 month
Level of high sensitive-CRP
Level of high sensitive-CRP
Measured: 6 month
Incidence of myopathy, rhabdomyolysis
Incidence of myopathy, rhabdomyolysis
Measured: 6 month
Frequency of drug discontinuation due to SAMS side effects
Frequency of drug discontinuation due to SAMS side effects
Measured: 6 month
Frequency of drug discontinuation due to side effects other than SAMS
Frequency of drug discontinuation due to side effects other than SAMS
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2021
- Study start11 Aug 2021
- Primary completion14 May 2023
- Study completion28 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (27)Papers the sponsor has linked to this study.
- Other trials for Atheroscleroses, CoronaryStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Effects of high-dose Statin Versus low-dose statin plus ezetimibe on statin-associated Muscle Symptoms
- Masking
- None (open label)
- Enrolment
- 582 participants (actual)
Sponsor and investigators
- Lead sponsor
- Korea University Anam Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Soon Jun Hong, Korea University Anam Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04826354
- Sponsor's protocol ID
- SaveSAMS
- Status last verified
- Aug 2023
- First submitted
- 25 Mar 2021
- Last updated
- 8 Aug 2023
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Baigent C, Keech A, Kearney PM, Blackwell L, Buck G, Pollicino C, Kirby A, Sourjina T, Peto R, Collins R, Simes R; Cholesterol Treatment Trialists' (CTT) Collaborators. Efficacy and safety of cholesterol-lowering treatment: prospective meta-analysis of data from 90,056 participants in 14 randomised trials of statins. Lancet. 2005 Oct 8;366(9493):1267-78. doi: 10.1016/S0140-6736(05)67394-1. Epub 2005 Sep 27.
PubMed 16214597Ference BA, Ginsberg HN, Graham I, Ray KK, Packard CJ, Bruckert E, Hegele RA, Krauss RM, Raal FJ, Schunkert H, Watts GF, Boren J, Fazio S, Horton JD, Masana L, Nicholls SJ, Nordestgaard BG, van de Sluis B, Taskinen MR, Tokgozoglu L, Landmesser U, Laufs U, Wiklund O, Stock JK, Chapman MJ, Catapano AL. Low-density lipoproteins cause atherosclerotic cardiovascular disease. 1. Evidence from genetic, epidemiologic, and clinical studies. A consensus statement from the European Atherosclerosis Society Consensus Panel. Eur Heart J. 2017 Aug 21;38(32):2459-2472. doi: 10.1093/eurheartj/ehx144.
PubMed 28444290Cholesterol Treatment Trialists' (CTT) Collaboration; Baigent C, Blackwell L, Emberson J, Holland LE, Reith C, Bhala N, Peto R, Barnes EH, Keech A, Simes J, Collins R. Efficacy and safety of more intensive lowering of LDL cholesterol: a meta-analysis of data from 170,000 participants in 26 randomised trials. Lancet. 2010 Nov 13;376(9753):1670-81. doi: 10.1016/S0140-6736(10)61350-5. Epub 2010 Nov 8.
PubMed 21067804Grundy SM, Stone NJ, Bailey AL, Beam C, Birtcher KK, Blumenthal RS, Braun LT, de Ferranti S, Faiella-Tommasino J, Forman DE, Goldberg R, Heidenreich PA, Hlatky MA, Jones DW, Lloyd-Jones D, Lopez-Pajares N, Ndumele CE, Orringer CE, Peralta CA, Saseen JJ, Smith SC Jr, Sperling L, Virani SS, Yeboah J. 2018 AHA/ACC/AACVPR/AAPA/ABC/ACPM/ADA/AGS/APhA/ASPC/NLA/PCNA Guideline on the Management of Blood Cholesterol: Executive Summary: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. J Am Coll Cardiol. 2019 Jun 25;73(24):3168-3209. doi: 10.1016/j.jacc.2018.11.002. Epub 2018 Nov 10. No abstract available.
PubMed 30423391European Association for Cardiovascular Prevention & Rehabilitation; Reiner Z, Catapano AL, De Backer G, Graham I, Taskinen MR, Wiklund O, Agewall S, Alegria E, Chapman MJ, Durrington P, Erdine S, Halcox J, Hobbs R, Kjekshus J, Filardi PP, Riccardi G, Storey RF, Wood D; ESC Committee for Practice Guidelines (CPG) 2008-2010 and 2010-2012 Committees. ESC/EAS Guidelines for the management of dyslipidaemias: the Task Force for the management of dyslipidaemias of the European Society of Cardiology (ESC) and the European Atherosclerosis Society (EAS). Eur Heart J. 2011 Jul;32(14):1769-818. doi: 10.1093/eurheartj/ehr158. Epub 2011 Jun 28.
PubMed 21712404Pokharel Y, Tang F, Jones PG, Nambi V, Bittner VA, Hira RS, Nasir K, Chan PS, Maddox TM, Oetgen WJ, Heidenreich PA, Borden WB, Spertus JA, Petersen LA, Ballantyne CM, Virani SS. Adoption of the 2013 American College of Cardiology/American Heart Association Cholesterol Management Guideline in Cardiology Practices Nationwide. JAMA Cardiol. 2017 Apr 1;2(4):361-369. doi: 10.1001/jamacardio.2016.5922.
PubMed 28249067Rodriguez F, Lin S, Maron DJ, Knowles JW, Virani SS, Heidenreich PA. Use of high-intensity statins for patients with atherosclerotic cardiovascular disease in the Veterans Affairs Health System: Practice impact of the new cholesterol guidelines. Am Heart J. 2016 Dec;182:97-102. doi: 10.1016/j.ahj.2016.09.007. Epub 2016 Sep 29.
PubMed 27914506Rosenson RS, Kent ST, Brown TM, Farkouh ME, Levitan EB, Yun H, Sharma P, Safford MM, Kilgore M, Muntner P, Bittner V. Underutilization of high-intensity statin therapy after hospitalization for coronary heart disease. J Am Coll Cardiol. 2015 Jan 27;65(3):270-7. doi: 10.1016/j.jacc.2014.09.088.
PubMed 25614424Riphagen IJ, van der Veer E, Muskiet FA, DeJongste MJ. Myopathy during statin therapy in the daily practice of an outpatient cardiology clinic: prevalence, predictors and relation with vitamin D. Curr Med Res Opin. 2012 Jul;28(7):1247-52. doi: 10.1185/03007995.2012.702102. Epub 2012 Jun 28.
PubMed 22686958Bruckert E, Hayem G, Dejager S, Yau C, Begaud B. Mild to moderate muscular symptoms with high-dosage statin therapy in hyperlipidemic patients--the PRIMO study. Cardiovasc Drugs Ther. 2005 Dec;19(6):403-14. doi: 10.1007/s10557-005-5686-z.
PubMed 16453090Armitage J. The safety of statins in clinical practice. Lancet. 2007 Nov 24;370(9601):1781-90. doi: 10.1016/S0140-6736(07)60716-8.
PubMed 17559928Nguyen KA, Li L, Lu D, Yazdanparast A, Wang L, Kreutz RP, Whipple EC, Schleyer TK. A comprehensive review and meta-analysis of risk factors for statin-induced myopathy. Eur J Clin Pharmacol. 2018 Sep;74(9):1099-1109. doi: 10.1007/s00228-018-2482-9. Epub 2018 May 22.
PubMed 29785580Cham S, Evans MA, Denenberg JO, Golomb BA. Statin-associated muscle-related adverse effects: a case series of 354 patients. Pharmacotherapy. 2010 Jun;30(6):541-53. doi: 10.1592/phco.30.6.541.
PubMed 20500044Rallidis LS, Fountoulaki K, Anastasiou-Nana M. Managing the underestimated risk of statin-associated myopathy. Int J Cardiol. 2012 Sep 6;159(3):169-76. doi: 10.1016/j.ijcard.2011.07.048. Epub 2011 Aug 2.
PubMed 21813193Cannon CP, Blazing MA, Giugliano RP, McCagg A, White JA, Theroux P, Darius H, Lewis BS, Ophuis TO, Jukema JW, De Ferrari GM, Ruzyllo W, De Lucca P, Im K, Bohula EA, Reist C, Wiviott SD, Tershakovec AM, Musliner TA, Braunwald E, Califf RM; IMPROVE-IT Investigators. Ezetimibe Added to Statin Therapy after Acute Coronary Syndromes. N Engl J Med. 2015 Jun 18;372(25):2387-97. doi: 10.1056/NEJMoa1410489. Epub 2015 Jun 3.
PubMed 26039521
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of High-dose StAtin Versus Low-dose Statin Plus Ezetimibe on Statin-Associated Muscle Symptoms & on Reaching Target LDL-C Levels Among Elderly Patients With Atherosclerotic Cardiovascular Disease
- ClinicalTrials.gov ID
- NCT04826354
- Acronym / sponsor ID
- SaveSAMS
- Conditions
- Atheroscleroses, Coronary
- Keywords
- Elderly, Statin, Ezetimibe
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 582 participants (actual)
- Lead sponsor
- Korea University Anam HospitalUniversity, hospital or other
- Study start
- 11 Aug 2021 (actual)
- Primary completion
- 14 May 2023 (actual)
- Study completion
- 28 Jun 2023 (actual)
- First posted
- 1 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
High-dose statins can reduce mortality and cardiovascular events in patients with established atherosclerotic cardiovascular disease (ASCVD). Therefore, US and European recommendations recommend that established ASCVD patients (coronary artery disease, cerebrovascular disease, peripheral vascular disease) use high-dose statins to lower LDL cholesterol levels by at least 50%. However, in actual practice, high-dose statins are relatively less used, and the reason is unclear, but it is believed to be due to concerns about the side effects of high-dose statins. Most of the side effects of statins are statin-associated muscle symptoms (SAMS), which are more common than the incidence in clinical studies, especially in frontline care. These muscle side effects are dose-dependent and are common at high doses, and the incidence is known to increase in the elderly over 70 years of age. However, the US recommendation recommends using high-dose statins to lower LDL cholesterol by 50% or more to prevent cardiovascular events even in ASCVD patients over 70 years of age.
Most early studies on lowering LDL cholesterol in ASCVD patients used high doses of statins. However, after introducing cholesterol absorption inhibitors ezetimibe and PCSK9 inhibitor, large-scale clinical studies have been conducted to lower LDL cholesterol using these drugs. In this study, as in the statin study, cardiovascular events were significantly reduced, and together with statins, it became a standard treatment for ASCVD patients. On the other hand, the clinical benefit shown in clinical studies using cholesterol-lowering agents so far depends entirely on how much LDL cholesterol is lowered and how long it is maintained in a low state, indicating that LDL cholesterol management is the core of arteriosclerosis treatment. In addition to high-dose statins, a combination of low-dose statins and ezetimibe can be cited as a method for lowering LDL cholesterol to more than 50%. In the latter case, it is expected that there will be an advantage of reducing muscle side effects by reaching the target LDL cholesterol level by using a low-dose statin. However, no studies compare the difference in muscle side effects between low-dose statins and ezetimibe combination drugs, which reduce LDL cholesterol to the same extent compared to high-dose statins, in elderly patients over 70 years of age with ASCVD. In this study, the association of low-dose rosuvastatin 5mg and ezetimibe combination (rosuvastatin 10/5mg) compared to high-dose rosuvastatin 20mg in elderly patients 70 years of age or older with established ASCVD. This study aims to compare and analyze the incidence of muscle symptoms (SAMS) and their effect on LDL cholesterol.
Detailed description
Established Atherosclerotic Cardiovascular Disease (ASCVD)
- Coronary artery disease meeting at least one of the following criteria:
- A history of coronary recanalization in multivessel coronary artery disease, evidenced by any of the following:
- Percutaneous coronary intervention (PCI) of one or more vessels, including branching arteries
- PCI or coronary artery bypass grafting (CABG) for >50% residual stenosis in separate vessels that have not undergone recanalization
- multivessel CABG at least 5 years prior to screening
- Significant coronary without prior revascularization, evidenced by >70% stenosis in at least one coronary artery, >50% stenosis in two or more coronary arteries, or >50% stenosis in the left main coronary artery arterial disease
- Known coronary calcium score > 100 in subjects who did not undergo coronary recanalization prior to randomization
- Cerebrovascular Disease meeting at least one of the following criteria:
- Previous transient ischemic attack with carotid artery stenosis in 50%
- 70% internal or external carotid artery stenosis or >50% stenosis of two or more
- Past history of recanalization of internal or external carotid artery
- Peripheral arterial disease meeting at least one of the following criteria:
- > 50% stenosis in the arteries of the extremities
- History of abdominal aortic treatment (percutaneous or surgical) for atherosclerotic disease
- Ankle Brachial Index (ABI) ≤ 0.90
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Effects of high-dose Statin Versus low-dose statin plus ezetimibe on statin-associated Muscle Symptoms
| Arm | Type | Receives |
|---|---|---|
| Rosuvastatin | Experimental | Drug: RosuvastatinRosuvastatin 20mg |
| Rosuvamibe | Active comparator | Drug: Rosuvastatin and EzetimibeRosuvastatin plus ezetimibe 10/5 |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (10 listed)
- Take statins or ezetimibe within the last 4 weeks
- In case of end-stage kidney disease (eGFR<30 ml/min/1.73m2)
- Heart surgery or major surgery is planned within the next 6 months
- Patients with chronic diseases such as severe lung disease, stroke, etc.
- Patients with chronic inflammatory diseases who require oral, intravenous, or intra-articular steroid treatment (Ointments, inhalants, or intranasal steroids are allowed)
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 |
|---|---|---|
| Rosuvastatin and EzetimibeRosuvastatin Versus Rosuvastatin plus Ezetimibe | Drug | Rosuvamibe |
| RosuvastatinRosuvastatin | Drug | Rosuvastatin |
Primary outcome
Statin-Associated Muscle Symptoms (SAMS)
Time frame: 6 month
Patients with a Proposed Statin Myalgia Index score of 7 or higher (Cardiovasc Drugs Ther 2003;17:459-465): * Aspects: muscle pain, muscle spasms, muscle stiffness, feeling of strength, ligament pain, etc. * Location: thigh, buttocks, calves, back muscle, proximal arms * Onset time after dosing: within 6 months * Deteriorating factors: exercise, rest, cold exposure, position change, fasting * Severe: Occurs in abnormalities in daily life, occurs in daily life, occurs in less than daily life
Target Low density lipoprotein cholesterol (LDL-C) achievement
Time frame: 6 month
Target LDL-C achievement (LDL <70mg/dL)
9 secondary outcomes
CK levels
Time frame: 6 month
GOT levels
Time frame: 6 month
GPT levels
Time frame: 6 month
Levels of Total cholesterol, LDL cholesterol, HDL cholesterol
Time frame: 6 month
Level of Triglyceride
Time frame: 6 month
Level of high sensitive-CRP
Time frame: 6 month
Incidence of myopathy, rhabdomyolysis
Time frame: 6 month
Frequency of drug discontinuation due to SAMS side effects
Time frame: 6 month
Frequency of drug discontinuation due to side effects other than SAMS
Time frame: 6 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2023.
- Background: PubMed 16214597Baigent C, Keech A, Kearney PM, Blackwell L, Buck G, Pollicino C, Kirby A, Sourjina T, Peto R, Collins R, Simes R; Cholesterol Treatment Trialists' (CTT) Collaborators. Efficacy and safety of cholesterol-lowering treatment: prospective meta-analysis of data from 90,056 participants in 14 randomised trials of statins. Lancet. 2005 Oct 8;366(9493):1267-78. doi: 10.1016/S0140-6736(05)67394-1. Epub 2005 Sep 27.
- Background: PubMed 28444290Ference BA, Ginsberg HN, Graham I, Ray KK, Packard CJ, Bruckert E, Hegele RA, Krauss RM, Raal FJ, Schunkert H, Watts GF, Boren J, Fazio S, Horton JD, Masana L, Nicholls SJ, Nordestgaard BG, van de Sluis B, Taskinen MR, Tokgozoglu L, Landmesser U, Laufs U, Wiklund O, Stock JK, Chapman MJ, Catapano AL. Low-density lipoproteins cause atherosclerotic cardiovascular disease. 1. Evidence from genetic, epidemiologic, and clinical studies. A consensus statement from the European Atherosclerosis Society Consensus Panel. Eur Heart J. 2017 Aug 21;38(32):2459-2472. doi: 10.1093/eurheartj/ehx144.
- Background: PubMed 21067804Cholesterol Treatment Trialists' (CTT) Collaboration; Baigent C, Blackwell L, Emberson J, Holland LE, Reith C, Bhala N, Peto R, Barnes EH, Keech A, Simes J, Collins R. Efficacy and safety of more intensive lowering of LDL cholesterol: a meta-analysis of data from 170,000 participants in 26 randomised trials. Lancet. 2010 Nov 13;376(9753):1670-81. doi: 10.1016/S0140-6736(10)61350-5. Epub 2010 Nov 8.
- Background: PubMed 30423391Grundy SM, Stone NJ, Bailey AL, Beam C, Birtcher KK, Blumenthal RS, Braun LT, de Ferranti S, Faiella-Tommasino J, Forman DE, Goldberg R, Heidenreich PA, Hlatky MA, Jones DW, Lloyd-Jones D, Lopez-Pajares N, Ndumele CE, Orringer CE, Peralta CA, Saseen JJ, Smith SC Jr, Sperling L, Virani SS, Yeboah J. 2018 AHA/ACC/AACVPR/AAPA/ABC/ACPM/ADA/AGS/APhA/ASPC/NLA/PCNA Guideline on the Management of Blood Cholesterol: Executive Summary: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. J Am Coll Cardiol. 2019 Jun 25;73(24):3168-3209. doi: 10.1016/j.jacc.2018.11.002. Epub 2018 Nov 10. No abstract available.
- Background: PubMed 21712404European Association for Cardiovascular Prevention & Rehabilitation; Reiner Z, Catapano AL, De Backer G, Graham I, Taskinen MR, Wiklund O, Agewall S, Alegria E, Chapman MJ, Durrington P, Erdine S, Halcox J, Hobbs R, Kjekshus J, Filardi PP, Riccardi G, Storey RF, Wood D; ESC Committee for Practice Guidelines (CPG) 2008-2010 and 2010-2012 Committees. ESC/EAS Guidelines for the management of dyslipidaemias: the Task Force for the management of dyslipidaemias of the European Society of Cardiology (ESC) and the European Atherosclerosis Society (EAS). Eur Heart J. 2011 Jul;32(14):1769-818. doi: 10.1093/eurheartj/ehr158. Epub 2011 Jun 28.
- Background: PubMed 28249067Pokharel Y, Tang F, Jones PG, Nambi V, Bittner VA, Hira RS, Nasir K, Chan PS, Maddox TM, Oetgen WJ, Heidenreich PA, Borden WB, Spertus JA, Petersen LA, Ballantyne CM, Virani SS. Adoption of the 2013 American College of Cardiology/American Heart Association Cholesterol Management Guideline in Cardiology Practices Nationwide. JAMA Cardiol. 2017 Apr 1;2(4):361-369. doi: 10.1001/jamacardio.2016.5922.
- Background: PubMed 27914506Rodriguez F, Lin S, Maron DJ, Knowles JW, Virani SS, Heidenreich PA. Use of high-intensity statins for patients with atherosclerotic cardiovascular disease in the Veterans Affairs Health System: Practice impact of the new cholesterol guidelines. Am Heart J. 2016 Dec;182:97-102. doi: 10.1016/j.ahj.2016.09.007. Epub 2016 Sep 29.
- Background: PubMed 25614424Rosenson RS, Kent ST, Brown TM, Farkouh ME, Levitan EB, Yun H, Sharma P, Safford MM, Kilgore M, Muntner P, Bittner V. Underutilization of high-intensity statin therapy after hospitalization for coronary heart disease. J Am Coll Cardiol. 2015 Jan 27;65(3):270-7. doi: 10.1016/j.jacc.2014.09.088.
- Background: PubMed 22686958Riphagen IJ, van der Veer E, Muskiet FA, DeJongste MJ. Myopathy during statin therapy in the daily practice of an outpatient cardiology clinic: prevalence, predictors and relation with vitamin D. Curr Med Res Opin. 2012 Jul;28(7):1247-52. doi: 10.1185/03007995.2012.702102. Epub 2012 Jun 28.
- Background: PubMed 16453090Bruckert E, Hayem G, Dejager S, Yau C, Begaud B. Mild to moderate muscular symptoms with high-dosage statin therapy in hyperlipidemic patients--the PRIMO study. Cardiovasc Drugs Ther. 2005 Dec;19(6):403-14. doi: 10.1007/s10557-005-5686-z.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Rosuvastatin and Ezetimibe and Rosuvastatin in people with Atheroscleroses, Coronary, run by Korea University Anam Hospital at 2 sites in South Korea.
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 0 inclusion and 10 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 8 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in South Korea. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Statin-Associated Muscle Symptoms (SAMS) (time frame: 6 month). The study lists 2 primary outcomes in all. 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 NCT04826354, which also lists 27 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 8 Aug 2023.