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

Coronary Artery Disease Clinical Trial

— PRECISE-IVUS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01043380
• Other study ID #: UMIN000002959
• Status: Completed
• Phase: Phase 4
• First received: January 5, 2010
• Last updated: March 30, 2015
• Start date: January 2010
• Est. completion date: September 2014

Study information

• Verified date: March 2015
• Source: Kumamoto University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 245
• Est. completion date: September 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 85 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Hypercholesterolemia
• Myocardial Ischemia

Intervention

Drug:
• Combination 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.
• Lipitor (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.

Locations

Country	Name	City	State
Japan	Kumamoto University	Kumamoto

Sponsors (1)

Lead Sponsor	Collaborator
Kumamoto University

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Absolute change from baseline to follow-up in percent atheroma volume (PAV) in the target lesion		before randomization & 9-12 months after randomization	No
Secondary	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	No
Secondary	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	No
Secondary	Percentage changes from baseline to follow-up in serum lipids		before randomization & 9-12 months after randomization	No
Secondary	Correlation between regression of coronary plaque and serum lipids profiles		before randomization & 9-12 months after randomization	No
Secondary	Changes in hs-CRP from baseline to follow-up		before randomization & 9-12 months after randomization	No
Secondary	Correlation between regression of coronary plaque and inflammatory markers (white blood cell count and hs-CRP)		before randomization & 9-12 months after randomization	No
Secondary	Change and percentage change from baseline to follow-up in the PV of the PCI target lesion		before randomization & 9-12 months after randomization	No
Secondary	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	No
Secondary	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	No
Secondary	All-cause death		before randomization & 9-12 months after randomization	No
Secondary	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	Yes