None listed
Conditions
Interventions
Drug : 1) Period 1 (Visit 1~2) Test group
- Test drug Repatha prefilled pen 420mg, 3 pens administered subcutaneously within 24 hours after randomization, then administration ended
- Atorva placebo, o
Sponsors
BUCHEON SEJONG HOSPITAL
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: ? Age range: 30-90 years old. ? Subjects with acute coronary syndrome. ? Subjects who have no history of taking lipid-lowering agents including statins and whose LDL-C is 55 mg/dl or higher ? Subjects who consented to participate in this clinical trial.
Exclusion criteria
Exclusion criteria: ? Subjects currently receiving PCSK9 inhibitors ? Subjects with cardiogenic shock lasting more than 10 minutes or who underwent cardiopulmonary resuscitation (CPR) for more than 10 minutes ? Subjects in whom the cause of acute coronary syndrome is considered to be coronary vasospasm at the time of screening ? Subjects with acute liver failure, decompensated cirrhosis, active liver disease, or alanine aminotransferase (ALT) levels greater than 3 times the upper limit of normal on the initial blood test ? Subjects with triglyceride levels greater than 500 mg/dL at the time of screening ? Subjects with secondary causes of dyslipidemia (e.g., nephrotic syndrome, hypothyroidism) ? Subjects concurrently receiving other investigational drugs ? Subjects with a history of hypersensitivity or allergy to the ingredients of the investigational product ? Subjects with genetic disorders such as muscle disease, concomitant use of cyclosporine, galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption ? Subjects who have received other investigational products within the past 30 days ? Subjects who are pregnant or planning to become pregnant, breastfeeding women, or women of childbearing potential who do not agree to use effective contraception Effective contraception includes oral contraceptives, implantation of an intrauterine device (IUD) or intrauterine system (IUS); however, the use of hormonal contraceptives is not permitted for female subjects. If the partner of a male subject is a woman of childbearing potential, the use of oral hormonal contraceptives by the partner is permitted. ? Subjects considered unsuitable for participation in this clinical trial by the principal investigator ? Subjects who are unable to receive the investigational product in accordance with the clinical trial protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| LDL-C reduction effect evaluated after 4 weeks (% LDL-C change from baseline at week 4);Rate of reaching LDL-C goal (<55mg/dL) evaluated after 8 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Rate of reaching LDL-C goal (LDL-C3 ULN, severe myalgia, CPK >3ULN, or the sum of severe adverse events requiring discontinuation of medication);Rate of Changes in Lp(a), Apo B, non-HDL-C, TG, HDL-C, Hs-CRP, PRU (platelet reactivity unit) and incidence of HPR (PRU =235 by the VerifyNow P2Y12 assay) assessed after 4 and 8 weeks | — |
Countries
Korea, Republic of
Contacts
Public ContactSu Jung Lee
BUCHEON SEJONG HOSPITAL
Outcome results
None listed