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

This study is currently recruiting participants.
Verified April 2013 by Kumamoto University
Sponsor:
Information provided by (Responsible Party):
Hisao Ogawa, Kumamoto University
ClinicalTrials.gov Identifier:
NCT01043380
First received: January 5, 2010
Last updated: April 17, 2013
Last verified: April 2013
  Purpose

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.


Condition Intervention Phase
Hypercholesterolemia
Coronary Artery Disease
Drug: Combination therapy with Lipitor [Atorvastatin] and Zetia [Ezetimibe]
Drug: Lipitor (Atorvastatin) monotherapy
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Plaque REgression With Cholesterol Absorption Inhibitor or Synthesis Inhibitor Evaluated by IntraVascular UltraSound

Resource links provided by NLM:


Further study details as provided by Kumamoto University:

Primary Outcome Measures:
  • Percentage change from baseline (before randomization) to follow-up (9-12 months after randomization) in the plaque volume (PV) [ Time Frame: before randomization & 9-12 months after randomization ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from baseline to follow-up in PV in the target lesion [ Time Frame: before randomization & 9-12 months after randomization ] [ Designated as safety issue: No ]
  • Change and percentage change from baseline to follow-up in the minimum lumen diameter (MLD) and percent diameter stenosis (%DS) [ Time Frame: before randomization & 9-12 months after randomization ] [ Designated as safety issue: No ]
  • Percentage changes from baseline to follow-up in serum lipids [ Time Frame: before randomization & 9-12 months after randomization ] [ Designated as safety issue: No ]
  • Correlation between regression of coronary plaque and serum lipids profiles [ Time Frame: before randomization & 9-12 months after randomization ] [ Designated as safety issue: No ]
  • Changes in hs-CRP from baseline to follow-up [ Time Frame: before randomization & 9-12 months after randomization ] [ Designated as safety issue: No ]
  • Correlation between regression of coronary plaque and inflammatory markers (white blood cell count and hs-CRP) [ Time Frame: before randomization & 9-12 months after randomization ] [ Designated as safety issue: No ]
  • Change and percentage change from baseline to follow-up in the PV of the PCI target lesion [ Time Frame: before randomization & 9-12 months after randomization ] [ Designated as safety issue: No ]
  • Change and percentage change from baseline to follow-up in the MLD and %DS of the PCI target lesion [ Time Frame: before randomization & 9-12 months after randomization ] [ Designated as safety issue: No ]
  • 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]) [ Time Frame: before randomization & 9-12 months after randomization ] [ Designated as safety issue: No ]
  • All-cause death [ Time Frame: before randomization & 9-12 months after randomization ] [ Designated as safety issue: No ]
  • Safety (Adverse events, subjective symptoms/objective findings, physical tests), blood tests [hematology, clinical chemistry, glucose metabolism test], urinalysis) [ Time Frame: before randomization & 9-12 months after randomization ] [ Designated as safety issue: Yes ]
  • Change in percent atheroma volume [ Time Frame: before randomization & 9-12 months after randomization ] [ Designated as safety issue: No ]

Estimated Enrollment: 300
Study Start Date: January 2010
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: LZ group 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.
Active Comparator: L group Drug: 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.

  Eligibility

Ages Eligible for Study:   30 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01043380

Contacts
Contact: Kenichi Tsujita, MD, PhD +81-96-373-5175 tsujita@kumamoto-u.ac.jp
Contact: Hisao Ogawa, MD, PhD +81-96-373-5175 ogawah@kumamoto-u.ac.jp

Locations
Japan
Kumamoto University Recruiting
Kumamoto, Japan, 8608556
Contact: Kenichi Tsujita, MD,PhD    +81963735175    tsujita@kumamoto-u.ac.jp   
Sponsors and Collaborators
Kumamoto University
Investigators
Study Chair: Hisao Ogawa, MD, PhD Kumamoto University, Graduate School of Medical Sciences
  More Information

No publications provided

Responsible Party: Hisao Ogawa, Professor, Kumamoto University
ClinicalTrials.gov Identifier: NCT01043380     History of Changes
Other Study ID Numbers: UMIN000002959
Study First Received: January 5, 2010
Last Updated: April 17, 2013
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Kumamoto University:
Heart Diseases
Hyperlipidemia
Atorvastatin
Ezetimibe
Cardiovascular Diseases
Hypercholesterolemia
Coronary Artery Disease
Dyslipidemias
Intravascular Ultrasound

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Hypercholesterolemia
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Atorvastatin
Ezetimibe
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Enzyme Inhibitors
Lipid Regulating Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 16, 2014