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

K

Kumamoto University

Status and phase

Completed
Phase 4

Conditions

Coronary Artery Disease
Hypercholesterolemia

Treatments

Drug: Combination therapy with Lipitor [Atorvastatin] and Zetia [Ezetimibe]
Drug: Lipitor (Atorvastatin) monotherapy

Study type

Interventional

Funder types

Other

Identifiers

NCT01043380
UMIN000002959

Details and patient eligibility

About

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.

Enrollment

245 patients

Sex

All

Ages

30 to 85 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

245 participants in 2 patient groups

LZ group
Experimental group
Treatment:
Drug: Combination therapy with Lipitor [Atorvastatin] and Zetia [Ezetimibe]
L group
Active Comparator group
Treatment:
Drug: Lipitor (Atorvastatin) monotherapy

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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