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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCTs071200032

Enrollment

Registered

2020-09-29

Start date

2020-11-26

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypercholesterolemia after coronary stenting hypercholesterolemia

Interventions

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

Eligibility

Sex/Gender

All

Inclusion criteria

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

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).

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
(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.	—

Measure

Time frame

(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.

—

Contacts

Public ContactTetsuya Matoba

Kyushu University Faculty of Medical Sciences

matoba@cardiol.med.kyushu-u.ac.jp+81-92-642-5360

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026