Skip to main content
OpenTrials
Completed

NCT Number: NCT01043380

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Hypercholesterolemia Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Artery Disease Coronary Disease Dyslipidemias Heart Diseases Hyperlipidemias Lipid Metabolism Disorders Metabolic Diseases Myocardial Ischemia Nutritional and Metabolic Diseases Vascular Diseases

Age range

30 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Kumamoto University

Kumamoto, 8608556, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Drug

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

Drug

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 outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  3. Percentage changes from baseline to follow-up in serum lipids

    Time frame: before randomization & 9-12 months after randomization

  4. Correlation between regression of coronary plaque and serum lipids profiles

    Time frame: before randomization & 9-12 months after randomization

  5. Changes in hs-CRP from baseline to follow-up

    Time frame: before randomization & 9-12 months after randomization

  6. 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

  7. 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

  8. 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

  9. 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

  10. All-cause death

    Time frame: before randomization & 9-12 months after randomization

  11. 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

Sponsors and collaborators

Lead sponsor

Kumamoto University

Other

Registry information

Acronym: PRECISE-IVUS

Important dates

Study start
2010
Primary completion
2014
Study completion
2014
First posted
Jan 6, 2010
Registry last updated
Apr 1, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.