Brief and Protocol-Based Intensive Lipid Management in Patients with Acute Coronary Syndrome

JRCT ID: jRCT1020240029

Registered date:04/10/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Acute coronary syndrome
• Date of first enrollment: 04/10/2024
• Target sample size: 330
• Study type: Interventional

Intervention(s)

Lipid-lowering therapy will be initiated and modified at admission and at the 4-week outpatient visit according to the following protocol
At admission.
(i) Patients not taking statin medications,
(ii) Patients taking statin medications but not at high doses (high doses are defined as rosuvastatin 20 mg, atorvastatin 20 mg, or pitavastatin 4 mg),
(iii) Patients already taking high-dose statins,
(iv) patients already taking ezetimibe in addition to high-dose statin.
In addition, based on LDL-C levels measured at admission as follows,
(a) high-dose statin,
(b) high-dose statin plus ezetimibe,
(c) high-dose statin + ezetimibe + PCSK9 inhibitor
or (iii) and (iv) patients with LDL-C < 55 mg/dL, no change in therapy.
At the 4-week outpatient follow-up, based on the re-measured LDL-C level, patients will receive an additional dose of ezetimibe or ezetimibe plus PCSK9 inhibitor and treatment modification.
If LDL-C less than 55 mg/dL or PCSK9 inhibitor is introduced at admission, no treatment modification will be made.

Outcome(s)

• Primary Outcome: Percentage of patients reaching LDL-C < 70 mg/dL at 6 months

Secondary Outcome

(1) Percentage of patients achieving LDL-C < 55 mg/dL at 6 months
(2) Change from baseline to 6 months in T-Chol, LDL-C, HDL-C, TG, apolipoprotein B, lipoprotein(a), and high sensitivity CRP
(3) Combined event of cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, or coronary revascularization up to 6 months.
(4) Serious adverse events, adverse events, abnormal liver function, myalgia/myopathy,
(5) Medication adherence, discontinuation/reduction of lipid-lowering therapy
(6) Comprehensive analysis of inflammatory and lipid markers

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: < 90age old
• Gender: Both

Include criteria

(1) Patients hospitalized with acute coronary syndrome (ST-segment elevation myocardial infarction/non-ST-segment elevation myocardial infarction/unstable angina) and underwent percutaneous coronary revascularization
(2) Men and women between the ages of 18 and 90 years (at the time of enrollment)
(3) Patients who are eligible for outpatient visits for follow-up after discharge from the hospital
(4) Patients who have given their written consent to participate in the study

Exclude criteria

(Exclusions to influence efficacy evaluation)
(1) Patients currently using a PCSK9 inhibitor
(2) Patients within 1 month of new start of statin or ezetimibe at the time of consent.
(3) Patients with a history of prior use of any of the following drugs at the time of obtaining consent, within the specified time period from the date of last administration are excluded. Prior use of statins or ezetimibe within 1 month; prior use of PCSK9 inhibitors within 3 months for evolocumab and within 9 months for increucilan.
(4) Patients undergoing coronary artery bypass grafting as treatment for acute coronary syndromes
(5) Patients participating in interventional studies of other lipid-lowering therapies
(6) Patients with homozygous familial hypercholesterolemia or strong clinical suspicion of such

(Exclusion to influence safety evaluation)
(7) Patients with active liver disease or a history of serious liver disease or persistent elevations in AST or ALT greater than 3 times the upper limit of normal
(8) Patients with a history of allergy or adverse drug reactions to statins, ezetimibe, or PCSK9 inhibitors
(9) Women who are pregnant, possibly pregnant, within 28 days postpartum, or lactating

(excluded from the risk/benefit balance)
(10) Patients whose life expectancy is expected to be less than 1 year
(11) Other patients deemed ineligible by the attending physician

Related Information

• Primary Sponsor: Yasuda Satoshi