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 (SaveSAMS trial)

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

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CRIS

Registry ID

KCT0006265

Enrollment

582

Registered

2021-06-16

Start date

2021-07-12

Completion date

Unknown

Last updated

2024-03-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Drug : IP1 : Crestor Tab. 20mg (rosuvastatin calcium20.8mg) -> high-dose statin IP2 : Rosuvamibe Tab. 10/5mg (ezetimibe 10.00mg, rosuvastatin calcium 5.2mg) -> low-dose statin plus ezetimibe

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) A person who is 70 years of age or older as of the date of consent 2) Arteriosclerotic cardiovascular disease (coronary artery disease, cerebrovascular disease, or peripheral vascular disease) 3) Subjects whose patients have agreed to the study plan and follow-up observation, and who have agreed in writing to the informed consent forms approved by the IRB/EC of the institution.

Exclusion criteria

Exclusion criteria: 1) Take statin or ezetemib within the last 4 weeks 2) In case of terminal kidney disease (eGFR<30 ml/min/1.73 m2) 3) If a heart operation or major surgery is planned within the next six months 4) Patients with chronic diseases such as severe lung disease and stroke with difficult activity 5) Patients with chronic inflammatory diseases requiring oral, intravenous, or intra-articular steroid treatment (Use of ointment, inhalants, or intra nasal steroids is permitted) 6) Cancer has been diagnosed within the past year or is currently undergoing chemotherapy 7) In the case of clinically significant abnormal findings that may infringe the safety of the study by determining the investigator identified in Screening visit, physical examination, blood test, or electrocardiogram test 8) Liver disease, bile obstruction, or liver enzyme level (ALT/AST) is more than three times the normal level 9) Subject has a disease with a life expectancy of not more than one year 10) If the procedures described in the study plan are not desired or compliance is not possible

Design outcomes

Primary

Measure	Time frame
Incidence of the statin-associated muscle symptom;Reach rate of target LDL-C	—

Secondary

Measure	Time frame
CK, GOT, GPT levels, Total cholesterol, LDL cholesterol, triglyceride, HDL cholesterol, high sensitive-CRP;Frequency of myopathy, rhabdomyolysis;Frequency of drug interruption due to side effects	—

Countries

Korea, Republic of

Contacts

Public ContactSe Eun Park

Korea University Anam Hospital

tpdmspark0312@gmail.com+82-2-920-6015

Outcome results