None listed
Conditions
Interventions
Drug : • A prospective, open-label, multicenter, randomized study
• 1:1 randomized assignment to a group receiving continuous high-intensity statin or a combination therapy of statin and ezetimibe.
•
Sponsors
Kangbuk Samsung Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients aged 18 years or older with both of the following diseases 1) Coronary artery disease • Patients with clinically diagnosed coronary artery disease. Coronary artery disease includes stable angina pectoris, unstable angina pectoris, acute non-ST-segment elevation myocardial infarction, and acute ST-segment elevation myocardial infarction. 2) Peripheral vascular disease • Patients who have previously undergone aortofemoral bypass surgery, limb bypass surgery, or percutaneous angioplasty of the ilium or lower artery. • Patients who have undergone limb or foot amputation for arterial vascular disease. • Patients with intermittent claudication who satisfy one or all of the following conditions a) Ankle-brachial index (ABI) less than 0.9 b) Confirmation of 50% or more peripheral vascular stenosis by angiography or Doppler ultrasound • Asymptomatic patients who have undergone previous carotid artery recanalization or have carotid artery stenosis of 50% or more confirmed by angiography or Doppler ultrasound - Patients who consented to the study
Exclusion criteria
Exclusion criteria: Patients who are breastfeeding or planning to become pregnant during the study period - Those with a history of serious side effects or hypersensitivity to statins - Patients who are currently taking drugs with strong interactions with statins (cytochrome p-450 3A4 or 2C9 inhibitors) - Those with risk factors for myopathy or rhabdomyolysis, such as hereditary muscle disorder, hypothyroidism, alcoholism, severe liver dysfunction (more than 3 times the normal value) - Patients with life expectancy less than 3 years - If it is judged that follow-up for more than 1 year is not possible - If you cannot understand or read the consent form
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of cardiac death, myocardial infarction, stroke, stent thrombosis or coronary revascularization procedures Severe limb ischemia leading to angioplasty (angioplasty, bypass surgery, amputation, thrombolysis), major amputation of the upper ankle due to vascular causes | — |
Secondary
| Measure | Time frame |
|---|---|
| All deaths 2. Cardiovascular related deaths 3. Cardiac deaths 4. Myocardial infarction (MI) 5. Ischemic stroke 6. Major coronary events (cardiac death, non-fatal myocardial infarction, hospitalization for unstable angina) 7. Coronary events (major 8. Major cerebrovascular events (death from cerebrovascular disease, non-fatal stroke) 9. Cerebrovascular events (major cerebrovascular events and transient ischemic attacks) 10. Incidence of hospitalization for heart failure . 11. All deaths, myocardial infarction, stroke 12. All hospitalizations related to cardiovascular disease 13. Percutaneous transluminal angioplasty due to peripheral artery disease (PAD) 14. Occurrence of severe lower limb ischemia 15. Lower limb amputation 16 Prescription rate according to statin dose (survey on actual intake – intake rate and discontinuation rate/reason) 17. Symptom improvement through questionnaire (KPAQ) 18. Ankle-brachial index improvement effect 18. LDL level absolute/relative change rate and goal attainment rate 19. Incidence of statin-related diabetes - Aminotransferase elevation: (ALT > 3 x ULN) - Creatine kinase elevation: (CK>5 x ULN) - Increase of creatinine | — |
Countries
Korea, Republic of
Contacts
Public ContactJongyoung Lee
Kangbuk Samsung Medical Center
Outcome results
None listed