PCSK9 Inhibitor Usage on Target Vessel Dysfunction in patients with hypercholesterolemia after coronary stenting, a Multicenter Randomized Controlled Trial

JRCT ID: jRCTs071200032

Registered date:29/09/2020

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Hypercholesterolemia after coronary stenting
• Date of first enrollment: 26/11/2020
• Target sample size: 42
• Study type: Interventional

Intervention(s)

statins given on day1 every day in orally and Evolocumab 140mg every 2weeks by hypodermic injection
statins given on day1 every day in orally

Outcome(s)

• Primary Outcome: Severity of coronary vasoconstriction (percent change of coronary vessel diameter) induced by the intracoronary Ach in the stent target vessel at 197 days (28 weeks) after the first administration of test drug.

Secondary Outcome

(1)Serum LDL cholesterol at 197 days (28 weeks) after administration of test drugs.
(2)Percent change in serum LDL cholesterol from baseline at 197 days (28 weeks) after administration of test drugs.
(3)The proportion of the subjects who achieved LDL-C goal as recommended by the JAS guideline (LDL-C <70 mg/dL) at 197 days (28 weeks) after administration of test drug.
(4)The incidence of coronary endothelial dysfunction (CED) in the stent target vessel at 197 days (28 weeks) after the first administration of test drug
(5)The incidence of target vessel dysfunction (TVD), which is a composite of CED, TVR, MI, and target vessel-related death at 197 days (28 weeks) after the first administration of test drug.

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

Coronary artery disease patients who underwent successful coronary stenting and will receive investigating lipid-lowering therapy within 8 weeks.
Patients whose LDL-C goal is <70mg/dL according to the Japanese Atherosclerosis Sciety Guideline 2022.
Patients who have LDL-C Cholesterol equal or more than 70 mg/dL and less than 140mg/dL (Friedewad's formula) under the treatment with high-dose or maximum tolerated dose of statins) with or without ezetimibe.

Exclude criteria

Patients who are planned coronary revascularization procedure(s) for residual coronary artery lesion(s).
Patients who have undergone a coronary artery bypass grafting.
Patients who have severe left ventricular dysfunction (LVEF<30% by ultrasound).

Related Information

• Primary Sponsor: Matoba Tetsuya
• Secondary Sponsor: AMGEN K.K.