Effect of Cholesterol Absorption Inhibitor Usage on Target Vessel Dysfunction after Coronary Stenting, A Randomized Controlled Trial

Effect of Cholesterol Absorption Inhibitor Usage on Target Vessel Dysfunction after Coronary Stenting, A Randomized Controlled Trial - Effect of Cholesterol Absorption Inhibitor Usage on Target Vessel Dysfunction after Coronary Stenting (CuVIC Trial)

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000005597

Enrollment

260

Registered

2011-05-13

Start date

2011-05-01

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

Ischemic heart disease

Interventions

Statin monotherapy Combination therapy ezetmibe 10mg and statin

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Satisfy the all conditions below. (1)After successful coronary stenting(target lesion stenosis<20%). (2)Written informed consent for this study. (3)Possible to undertake 6-8 month follow-up coronary angiography at our institutions. (4)Over 20 years old, male and female.

Exclusion criteria

Exclusion criteria: Statisfy even one of the conditions below. (1)Not completed all planned PCI. (2)Participant of other clinical trial interfering with this study. (3)Chronic dialysis, chronic liver cirrhosis. (4)Severely impaired LV function, EF<30%. (5)Contraindication for statins or ezetimibe.

Design outcomes

Primary

Measure	Time frame
Target Vessel Dysfunction, 6-8 months after coronary stenting. Definition of Target Vessel Dysfunction(TVD) is a composite end point, target vessel-related cardiac death and target vessel-related myocardial infarction and ischemia-driven target vessel revascularization (TVF, Target Vessel Failure) and coronary endotherial dysfunction (positive for Acetylcholine provocation test performed, if no TVF).	—

Measure

Time frame

Target Vessel Dysfunction, 6-8 months after coronary stenting. Definition of Target Vessel Dysfunction(TVD) is a composite end point, target vessel-related cardiac death and target vessel-related myocardial infarction and ischemia-driven target vessel revascularization (TVF, Target Vessel Failure) and coronary endotherial dysfunction (positive for Acetylcholine provocation test performed, if no TVF).

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Secondary

Measure	Time frame
(1) Clinical course Target Vessel Failure, all cause death, cardiovascular death, cardiac death, coronary artery disease death, resuscitated cardiac arrest, myocardial infarction (MI), non-fatal MI, procedure related MI, non-procedure related MI, revascularization for coronary artery disease, binary restenosis, Canadian Cardiovascular Society Scale and revascularization for peripheral arterial disease (2) Coronary arterial endotherial function, Peripheral arterial endotherial function coronary arterial endotherial dysfunction (positive for Acetylcholine provocation test performed, if no TVF) Ach-related coronary arterial contraction/dilation endotherial function measured using Endo-PAT (FMD) (3) Surrogate markers oxidized cholesterol, oxidized LDL, oxidative stress (TBARS) lipid profile (T-Chol, TG, LDL, HDL, ApoB, ApoA1) inflammation marker (hCRP, MCP-1), adiponectine, ROCK activity, PAI-1 (4) Assessment of atherosclerosis coronary angiogram, in-stent late lumen loss, stenosis at non-target lesion IVUS. plaque volume, plaque phenotype PWV/ABI carotid ultrasound, IMT coronay CT angiogram, plaque volume, plaque phenotype, perfusion image, pericardial adipose tissue (5) Assessment of peripheral artery disease WIQ score, Treadmill test, ABI (6) Stratified analysis according to the type of stent and subgroup analysis according to the patient backgrounds and things listed above. (7) Clinical follow-up during 24 months after registration.	—

Measure

Time frame

(1) Clinical course Target Vessel Failure, all cause death, cardiovascular death, cardiac death, coronary artery disease death, resuscitated cardiac arrest, myocardial infarction (MI), non-fatal MI, procedure related MI, non-procedure related MI, revascularization for coronary artery disease, binary restenosis, Canadian Cardiovascular Society Scale and revascularization for peripheral arterial disease (2) Coronary arterial endotherial function, Peripheral arterial endotherial function coronary arterial endotherial dysfunction (positive for Acetylcholine provocation test performed, if no TVF) Ach-related coronary arterial contraction/dilation endotherial function measured using Endo-PAT (FMD) (3) Surrogate markers oxidized cholesterol, oxidized LDL, oxidative stress (TBARS) lipid profile (T-Chol, TG, LDL, HDL, ApoB, ApoA1) inflammation marker (hCRP, MCP-1), adiponectine, ROCK activity, PAI-1 (4) Assessment of atherosclerosis coronary angiogram, in-stent late lumen loss, stenosis at non-target lesion IVUS. plaque volume, plaque phenotype PWV/ABI carotid ultrasound, IMT coronay CT angiogram, plaque volume, plaque phenotype, perfusion image, pericardial adipose tissue (5) Assessment of peripheral artery disease WIQ score, Treadmill test, ABI (6) Stratified analysis according to the type of stent and subgroup analysis according to the patient backgrounds and things listed above. (7) Clinical follow-up during 24 months after registration.

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Countries

Japan

Contacts

Public ContactTetsuya Matoba

Kyushu University Graduate School of Medical Sciences Department of Cardiovascular Medicine

cuvic@med.kyushu-u.ac.jp092-642-5370

Outcome results

None listed

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