Status:
COMPLETED
Japan Assessment of Pitavastatin and Atorvastatin in Acute Coronary Syndrome (JAPAN-ACS)
Lead Sponsor:
Kyoto University
Collaborating Sponsors:
Yamaguchi University Hospital
Juntendo University
Conditions:
Coronary Disease
Hypercholesterolemia
Eligibility:
All Genders
20+ years
Phase:
PHASE4
Brief Summary
The purpose of this study is to compare the effects of pitavastatin and atorvastatin on coronary plaque volume in patients with acute coronary syndrome and to clarify the relationship between coronary...
Detailed Description
Previous mega trials have demonstrated that lipid lowering therapy with HMG-CoA reductase inhibitors (statins) reduces the incidence of major cardiovascular events by one-third, thus, the benefit of l...
Eligibility Criteria
Inclusion
- Patients with written consent by their own volition after being provided sufficient explanation for their participation in this clinical trial
- Patients 20 years or older at the time of their consent
- Patients with hypercholesterolemia as defined by any of the following criteria:
- TC \>= 220 mg/dL;
- LDL-C \>= 140 mg/dL;
- Cholesterol-lowering treatment is necessary in accordance with the investigator's judgement when LDL-C \>= 100 mg/dL or TC \>= 180 mg/dL.
- Patients who have been diagnosed with acute coronary syndrome
- Patients with successful percutaneous coronary intervention (PCI) by intravascular ultrasound (IVUS) guidance
- Patients having coronary plaques (\>= 500 µm in thickness or 20% or more in % plaque) at \>= 5 mm from the previously treated area in the same branch of coronary artery
Exclusion
- Patients with bypass graft or in-stent restenosis at the site of PCI
- Patients who had received PCI on the lesion in the past where the evaluation of coronary plaque volume is planned
- Patients who had plaques in a non-culprit site and might receive PCI during the treatment period
- Patients receiving lipid-lowering drugs (statins, fibrates, probucol, nicotinic acid or cholesterol absorption inhibitors)
- Patients with familial hypercholesterolemia
- Patients with cardiogenic shock
- Patients receiving cyclosporine
- Patients with any allergy to pitavastatin or atorvastatin
- Patients with hepatobiliary disorders
- Pregnant women, women suspected of being pregnant, or lactating women
- Patients with renal disorders or undergoing dialysis
- Patients who are ineligible in the opinion of the investigator
Key Trial Info
Start Date :
November 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2008
Estimated Enrollment :
307 Patients enrolled
Trial Details
Trial ID
NCT00242944
Start Date
November 1 2005
End Date
March 1 2008
Last Update
October 4 2023
Active Locations (3)
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1
Juntendo University School of Medicine
Bunkyo-ku, Tokyo, Japan, 113-8421
2
Yamaguchi University Graduate School of Medicine
Ube, Yamaguchi, Japan, 755-8505
3
Kyoto University Graduate School of Medicine
Kyoto, Japan, 606-8507