PCSK9 Inhibitor Usage on Target Vessel Dysfunction in patients with hypercholesterolemia after coronary stenting, a Multicenter Randomized Controlled Trial (CuVIC-2 Trial)

Completed

• Conditions: Hypercholesterolemia after coronary stenting

• Registration Number: jRCTs071200032

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-09-29
• Study Start: 2020-11-26
• Last Update Posted: 2024-06-30

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 42

Inclusion 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.

Exclusion 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).

Study & Design

• Study Type: Interventional
• Study Design: parallel assignment

Primary Outcome Measures

Name	Time	Method
Severity of coronary vasoconstriction	197 days (28 weeks) after the first administration of test drug	percent change of coronary vessel diameter induced by the intracoronary Ach in the stent target vessel

Secondary Outcome Measures

Name	Time	Method
Serum LDL cholesterol at 197 days (28 weeks) after administration of test drugs	197 days (28 weeks)	Serum LDL cholesterol at 197 days (28 weeks) after administration of test drugs.
Percent change in serum LDL cholesterol from baseline at 197 days (28 weeks) after administration of test drugs	197 days (28 weeks)	Percent change in serum LDL cholesterol from baseline at 197 days (28 weeks) after administration of test drugs.
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	197 days (28 weeks)	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.
The incidence of coronary endothelial dysfunction (CED) in the stent target vessel at 197 days (28 weeks) after the first administration of test drug	197 days (28 weeks)	The incidence of coronary endothelial dysfunction (CED) in the stent target vessel at 197 days (28 weeks) after the first administration of test drug.
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	197 days (28 weeks)	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.