Back to results

Plaque REgression With Cholesterol Absorption Inhibitor or Synthesis Inhibitor Evaluated by IntraVascular UltraSound (PRECISE-IVUS)

Primary Purpose

Hypercholesterolemia, Coronary Artery Disease

Status

Completed

Phase

Phase 4

Locations

Japan

Study Type

Interventional

Intervention

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

Lipitor (Atorvastatin) monotherapy

About this trial

This is an interventional treatment trial for Hypercholesterolemia focused on measuring Heart Diseases, Hyperlipidemia, Atorvastatin, Ezetimibe, Cardiovascular Diseases, Hypercholesterolemia, Coronary Artery Disease, Dyslipidemias, Intravascular Ultrasound

Eligibility Criteria

30 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Kumamoto University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

LZ group

L group

Arm Description

Outcomes

Primary Outcome Measures

Absolute change from baseline to follow-up in percent atheroma volume (PAV) in the target lesion

Secondary Outcome Measures

Percentage change from baseline (before randomization) to follow-up (9-12 months after randomization) in the atheroma volume

Change and percentage change from baseline to follow-up in the minimum lumen diameter (MLD) and percent diameter stenosis (%DS)

Percentage changes from baseline to follow-up in serum lipids

Correlation between regression of coronary plaque and serum lipids profiles

Changes in hs-CRP from baseline to follow-up

Correlation between regression of coronary plaque and inflammatory markers (white blood cell count and hs-CRP)

Change and percentage change from baseline to follow-up in the PV of the PCI target lesion

Change and percentage change from baseline to follow-up in the MLD and %DS of the PCI target lesion

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])

All-cause death

Safety (Adverse events, subjective symptoms/objective findings, physical tests), blood tests [hematology, clinical chemistry, glucose metabolism test], urinalysis)

Full Information

NCT ID

NCT01043380

First Posted

January 5, 2010

Last Updated

March 30, 2015

Sponsor

Kumamoto University

1. Study Identification

Unique Protocol Identification Number

NCT01043380

Brief Title

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

Acronym

PRECISE-IVUS

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2015

Overall Recruitment Status

Completed

Study Start Date

January 2010 (undefined)

Primary Completion Date

March 2014 (Actual)

Study Completion Date

September 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Kumamoto University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hypercholesterolemia, Coronary Artery Disease

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

245 (Actual)

8. Arms, Groups, and Interventions

Arm Title

LZ group

Arm Type

Experimental

Arm Title

L group

Arm Type

Active Comparator

Intervention Type

Drug

Intervention Name(s)

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

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Lipitor (Atorvastatin) monotherapy

Intervention Description

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.

Primary Outcome Measure Information:

Title

Absolute change from baseline to follow-up in percent atheroma volume (PAV) in the target lesion

Time Frame