Plaque REgression With Cholesterol Absorption Inhibitor or Synthesis Inhibitor Evaluated by IntraVascular UltraSound

Conditions

Coronary Artery Disease, Hypercholesterolemia

Keywords

Heart Diseases, Hyperlipidemia, Atorvastatin, Ezetimibe, Cardiovascular Diseases, Hypercholesterolemia, Coronary Artery Disease, Dyslipidemias, Intravascular Ultrasound

Brief summary

The purpose of this study was to evaluate the difference in the effect of coronary plaque regression (as measured by intravascular ultrasound \[IVUS\] imaging) between cholesterol absorption inhibitor and cholesterol synthesis inhibitor.

Fujisue K, Nagamatsu S, Shimomura H, Yamashita T, Nakao K, Nakamura S, Ishihara M, Matsui K, Yamamoto N, Koide S, Matsumura T, Fujimoto K, Tsunoda R, Morikami Y, Matsuyama K, Oshima S, Sakamoto K, Izumiya Y, Kaikita K, Hokimoto S, Ogawa H, Tsujita K.

2018-06-185 citations

10.1016/j.ijcard.2018.04.051

Impact of Dual Lipid-Lowering Strategy With Ezetimibe and Atorvastatin on Coronary Plaque Regression in Patients With Percutaneous Coronary Intervention: The Multicenter Randomized Controlled PRECISE-IVUS Trial.

Tsujita K, Sugiyama S, Sumida H, Shimomura H, Yamashita T, Yamanaga K, Komura N, Sakamoto K, Oka H, Nakao K, Nakamura S, Ishihara M, Matsui K, Sakaino N, Nakamura N, Yamamoto N, Koide S, Matsumura T, Fujimoto K, Tsunoda R, Morikami Y, Matsuyama K, Oshima S, Kaikita K, Hokimoto S, Ogawa H, PRECISE–IVUS Investigators.

2015-08-01313 citations

10.1016/j.jacc.2015.05.065

Interventions

DRUGCombination therapy with Lipitor [Atorvastatin] and Zetia [Ezetimibe]

Zetia 10 mg/dl + Lipitor. The dosage of Lipitor will be titrated up to a maximum of 20 mg/day with a treatment goal of lowering LDL-C below 70 mg/dl.

DRUGLipitor (Atorvastatin) monotherapy

The dosage will be titrated up to a maximum of 20 mg/day, which is the highest approved regimen by the Ministry of Health, Labor and Welfare of Japan, with a treatment goal of lowering LDL-C below 70 mg/dl.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

30 Years to 85 Years

Healthy volunteers

No

Inclusion criteria

* Signed written informed consent, * 30 to 85 years old, * Plan to undergo PCI and LDL-C \>= 100 mg/dL

Exclusion criteria

* Familial hypercholesterolemia * Being treated with Zetia (Ezetimibe) * Being treated with Fibrates * Renal insufficiency (serum creatinine \>= 2.0 mg/dl) * Altered hepatic function (serum aspartate aminotransferase or alanine aminotransferase \>= 3-folds of standard value in each institute) * Undergoing hemodialysis or peritoneal dialysis * Allergic to Lipitor and/or Zetia * Severe underlying disease * Lack of decision-making capacity * Recognized as inadequate by attending doctor

Design outcomes

Primary

Measure	Time frame
Absolute change from baseline to follow-up in percent atheroma volume (PAV) in the target lesion	before randomization & 9-12 months after randomization

Secondary

Measure	Time frame
Changes in hs-CRP from baseline to follow-up	before randomization & 9-12 months after randomization
Change and percentage change from baseline to follow-up in the minimum lumen diameter (MLD) and percent diameter stenosis (%DS)	before randomization & 9-12 months after randomization
Percentage change from baseline (before randomization) to follow-up (9-12 months after randomization) in the atheroma volume	before randomization & 9-12 months after randomization
Percentage changes from baseline to follow-up in serum lipids	before randomization & 9-12 months after randomization
Correlation between regression of coronary plaque and inflammatory markers (white blood cell count and hs-CRP)	before randomization & 9-12 months after randomization
Correlation between regression of coronary plaque and serum lipids profiles	before randomization & 9-12 months after randomization
Change and percentage change from baseline to follow-up in the MLD and %DS of the PCI target lesion	before randomization & 9-12 months after randomization
MACE (cardiac death, non-fatal Q wave and/or non-Q wave myocardial infarction, target vessel revascularization [percutaneous coronary intervention or coronary artery bypass grafting])	before randomization & 9-12 months after randomization
All-cause death	before randomization & 9-12 months after randomization
Safety (Adverse events, subjective symptoms/objective findings, physical tests), blood tests [hematology, clinical chemistry, glucose metabolism test], urinalysis)	before randomization & 9-12 months after randomization
Change and percentage change from baseline to follow-up in the PV of the PCI target lesion	before randomization & 9-12 months after randomization

Countries

Japan

Outcome results

None listed