Clinical trial NCT01223586: Extended Japan Assessment of Pitavastatin and Atorvastatin in Acute Coronary Syndrome
Official title: Extended Japan Assessment of Pitavastatin and Atorvastatin in Acute Coronary Syndrome
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Statin
Coronary Plaque
Acute Coronary Syndrome
Intravascular Ultrasound
Cardiovascular Events
Lead sponsor: Kyoto University Hospital
Sponsor class: OTHER
Collaborators: name: Yamaguchi University Hospital
First posted: 2010-10-19
Enrollment: 238
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Cohort of participants of JAPAN-ACS trial who completed the study

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 Atorvastatin in Acute Coronary Syndrome (JAPAN-ACS) study \[NCT00242944\]. In addition, the effect of serum lipid levels or different type of statins on cardiovascular prevention will also be examined.

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. Indeed, the Japan Assessment of Pitavastatin and Atorvastatin in Acute Coronary Syndrome (JAPAN-ACS) trial \[NCT00242944\] has revealed that early aggressive statin therapy in patients with acute coronary syndrome (ACS) significantly reduces the plaque volume of non-culprit coronary lesions On the other hands, a direct relationship between atheroma progression and regression on IVUS and clinical events has not been clearly defined. To verify that relationship, long term follow up of the JAPAN-ACS study will be performed. Clinical outcome of patients with regressed plaque and progressed plaque will be compared. In addition, the objectives of this study are to evaluate the effect of serum lipid levels or different type of statins on cardiovascular prevention.

Eligibility criteria: At the enrollment of original study

Inclusion Criteria:

* 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 Criteria:

* 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

Primary outcomes:
measure: Composite endpoint
timeFrame: 4-year
Secondary outcomes:
measure: Composite cardiovascular events
timeFrame: 4-year
measure: Composite coronary heart disease events
timeFrame: 4-year
measure: Composite cerebrovascular events
timeFrame: 4-year
measure: Mortality
timeFrame: 4-year
measure: Heart disease events
timeFrame: 4-year
measure: Cerebrovascular events
timeFrame: 4-year
measure: Other events
timeFrame: 4-year
Other outcomes:
Locations:
city: Ube
country: Japan
facility: Division of Cardiology, Department of Medicine and Clinical Science, Yamaguchi University Graduate School of Medicine
state: Yamaguchi
city: Kyoto
country: Japan
facility: Division of Cardiology, Kyoto University Hospital
Study officials:
affiliation: Professor of Division of Cardiology, Department of Medicine and Clinical Science, Yamaguchi University Graduate School of Medicine
name: Masunori Matsuzaki, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Miyauchi K, Daida H, Morimoto T, Hiro T, Kimura T, Nakagawa Y, Yamagishi M, Ozaki Y, Kadota K, Kimura K, Hirayama A, Kimura K, Hasegawa Y, Uchiyama S, Matsuzaki M; JAPAN-ACS Investigators. Reverse vessel remodeling but not coronary plaque regression could predict future cardiovascular events in ACS patients with intensive statin therapy--the extended JAPAN-ACS study. Circ J. 2012;76(4):825-32. doi: 10.1253/circj.cj-12-0135.