Status:
COMPLETED
Extended Japan Assessment of Pitavastatin and Atorvastatin in Acute Coronary Syndrome
Lead Sponsor:
Kyoto University
Collaborating Sponsors:
Yamaguchi University Hospital
Conditions:
Statin
Coronary Plaque
Eligibility:
All Genders
20+ years
Brief Summary
The objective of this study is to verify the relationship between coronary plaque regression and cardiovascular prevention in long term follow up of the Japan Assessment of Pitavastatin and Atorvastat...
Detailed Description
Several previous multicenter studies using intravascular ultrasound (IVUS) imaging have revealed that statins attenuate the progression of atherosclerosis or even provide regression of plaque volume. ...
Eligibility Criteria
Inclusion
- At the enrollment of original study
- 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 2010
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 1 2011
Estimated Enrollment :
238 Patients enrolled
Trial Details
Trial ID
NCT01223586
Start Date
November 1 2010
End Date
May 1 2011
Last Update
April 24 2012
Active Locations (2)
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1
Division of Cardiology, Kyoto University Hospital
Kyoto, Kyoto, Japan, 606-8507
2
Division of Cardiology, Department of Medicine and Clinical Science, Yamaguchi University Graduate School of Medicine
Ube, Yamaguchi, Japan, 755-8505