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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Hisao Ogawa, Kumamoto University
ClinicalTrials.gov Identifier:
NCT01043380
First received: January 5, 2010
Last updated: May 27, 2014
Last verified: May 2014
  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: Efficacy 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:
  • Absolute change from baseline to follow-up in percent atheroma volume (PAV) in the target lesion [ Time Frame: before randomization & 9-12 months after randomization ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Percentage change from baseline (before randomization) to follow-up (9-12 months after randomization) in the atheroma volume [ 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 ]

Enrollment: 245
Study Start Date: January 2010
Estimated Study Completion Date: September 2014
Primary Completion Date: March 2014 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Japan
Kumamoto University
Kumamoto, Japan, 8608556
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: May 27, 2014
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
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on August 28, 2014