Yokohama Assessment of Fluvastatin, Pravastatin, Pitavastatin and Atorvastatin in Acute Coronary Syndrome (Yokohama-ACS)

• Status: Completed
• Trial end date: 2010-02-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to compare the effects of fluvastatin, pravastatin, pitavastatin, and atorvastatin on coronary plaque volume in patients with acute coronary syndrome, and to clarify the impact of moderate and intensive lipid lowering therapy on coronary plaque volume, serum lipids, and inflammation markers in patients with acute coronary syndrome in Japanese.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Yokohama City University Medical Center
• Treatments: Atorvastatin; Atorvastatin Calcium; Fluvastatin; Pitavastatin; Pravastatin

Criteria

Inclusion Criteria:

1. Patients who have been diagnosed as acute coronary syndrome, and successful percutaneous coronary intervention (PCI) were performed with intravascular ultrasound (IVUS) guidance.

2. Patients having coronary plaques (≧ 500 µm in thickness or % plaque of 20% or more at ≧ 5 mm distal or proximal to the previously treated area in the same branch of coronary artery.

3. Patients with hypercholesterolemia as defined by any of the following criteria:

• TC ≧ 220 mg/dL

• LDL-C ≧ 140 mg/dL Cholesterol-lowering treatment is allowed according to the investigator's judgement when LDL-C ≧ 100 mg/dL or TC ≧ 180 mg/dL.

4. Patients with written consent by their own volition after being provided sufficient explanation for their participation in this clinical trial.

5. Patients 20 years or older at the time of their consent.

Exclusion Criteria:

1. Patients with bypass graft or in-stent restenosis at the site of PCI.

2. Patients who received PCI in the past on the lesion where the evaluation of coronary plaque volume is planned.

3. Patients who had plaques in a non-culprit site and might receive PCI during the treatment period.

4. Patients receiving lipid-lowering drugs (statins, fibrates, probucol, nicotinic acid or cholesterol absorption inhibitors).

5. Patients with familial hypercholesterolemia.

6. Patients with cardiogenic shock.

7. Patients receiving cyclosporine.

8. Patients with any allergy to pravastatin, fluvastatin, pitavastatin, or atorvastatin.

9. Patients with hepatobiliary disorders.

10. Pregnant women, women suspected of being pregnant, or lactating women.

11. Patients with renal disorders or undergoing dialysis.

12. Patients who are ineligible in the opinion of the investigator.