A comparative study of EVOlocumab and high-intensity statin for EARLY and intensive LDL-Cholesterol reduction in patients with acute coronary syndrome; Multi-center, prospective, randomized, double blinded, sham-procedure and placebo controlled trial
- Conditions
- Diseases of the circulatory system
- Registration Number
- KCT0009668
- Lead Sponsor
- BUCHEON SEJONG HOSPITA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 108
? Age range: 30-90 years old.
? Patient with acute coronary syndrome.
? Patients with no prior history of statin use or those using low or moderate intensity statins but having an LDL-C level of 55 mg/dL or higher.
? Participants who consented to participate in this clinical trial.
? Patients continuing to receive PCSK9 inhibitors
? In case of cardiogenic shock lasting more than 10 minutes or CPR performed for more than 10 minutes
? Patients whose CPK levels increased to more than 3 times the upper limit of the normal range during screening
? Patients with acute liver failure, decompensated cirrhosis, active liver disease, or if ALT is more than 3 times the upper limit of the normal range on the initial blood test
? Those with secondary causes of dyslipidemia (nephrotic syndrome, hypothyroidism, etc.)
? Persons taking concurrently Investigational drugs
? If there is a history of hypersensitivity or allergy to the ingredients of the Investigational drug.
? Those with genetic problems such as muscle disease, concurrent use of cyclosporine, galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption.
? Persons who have received other clinical investigational drugs within the past 30 days
? Those who are pregnant or planning to become pregnant, lactating women, or women of childbearing potential who do not agree to use effective contraception.
Oral contraceptives, implantation of an intrauterine device or intrauterine system, but the use of hormonal contraceptives is not permitted. If the female partner of a male subject is a female partner, the use of oral hormonal contraceptives is permitted.
? Other persons judged by the principal investigator to be unsuitable for participation in this clinical trial
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method