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

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