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

January 5, 2010
May 27, 2014
January 2010
March 2014   (final data collection date for primary outcome measure)
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 ]
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 ]
Complete list of historical versions of study NCT01043380 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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 ]
Not Provided
Not Provided
 
Plaque REgression With Cholesterol Absorption Inhibitor or Synthesis Inhibitor Evaluated by IntraVascular UltraSound
Plaque REgression With Cholesterol Absorption Inhibitor or Synthesis Inhibitor Evaluated by IntraVascular UltraSound

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Hypercholesterolemia
  • Coronary Artery Disease
  • 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.
  • 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.
  • Experimental: LZ group
    Intervention: Drug: Combination therapy with Lipitor [Atorvastatin] and Zetia [Ezetimibe]
  • Active Comparator: L group
    Intervention: Drug: Lipitor (Atorvastatin) monotherapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
245
September 2014
March 2014   (final data collection date for primary outcome measure)

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
Both
30 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT01043380
UMIN000002959
Yes
Hisao Ogawa, Kumamoto University
Kumamoto University
Not Provided
Study Chair: Hisao Ogawa, MD, PhD Kumamoto University, Graduate School of Medical Sciences
Kumamoto University
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP