---
title: Extended Japan Assessment of Pitavastatin and Atorvastatin in Acute Coronary Syndrome
nct_id: NCT01223586
overall_status: COMPLETED
sponsor: Kyoto University
study_type: OBSERVATIONAL
primary_condition: Statin
countries: Japan
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT01223586.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT01223586"
ct_last_update_post_date: 2012-04-24
last_seen_at: "2026-05-12T06:18:39.185Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Extended Japan Assessment of Pitavastatin and Atorvastatin in Acute Coronary Syndrome

**NCT ID:** [NCT01223586](https://clinicaltrials.gov/study/NCT01223586)

## Key Facts

- **Status:** COMPLETED
- **Study Type:** OBSERVATIONAL
- **Target Enrollment:** 238
- **Lead Sponsor:** Kyoto University
- **Collaborators:** Yamaguchi University Hospital
- **Conditions:** Statin, Coronary Plaque, Acute Coronary Syndrome, Intravascular Ultrasound, Cardiovascular Events
- **Start Date:** 2010-11
- **Completion Date:** 2011-05
- **CT.gov Last Update:** 2012-04-24

## 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

- **Minimum age:** 20 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
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
```

## Arms

- **Regression** — Patients with regression of plaque volume by statin
- **Non regression** — Patients without regression of plaque volume by statin

## Primary Outcomes

- **Composite endpoint** _(time frame: 4-year)_ — Occurrence of one of following events:

Cardiovascular death (death from cardiac cause or stroke or peripheral artery disease) Non-fatal Myocardial Infarction (MI) Non-fatal Cerebral Infarction (CI) except for transient ischemic attack (TIA) Unstable angina requiring urgent hospitalizations

## Secondary Outcomes

- **Composite cardiovascular events** _(time frame: 4-year)_
- **Composite coronary heart disease events** _(time frame: 4-year)_
- **Composite cerebrovascular events** _(time frame: 4-year)_
- **Mortality** _(time frame: 4-year)_
- **Heart disease events** _(time frame: 4-year)_
- **Cerebrovascular events** _(time frame: 4-year)_
- **Other events** _(time frame: 4-year)_

## Locations (2)

- Division of Cardiology, Kyoto University Hospital, Kyoto, Kyoto, Japan
- Division of Cardiology, Department of Medicine and Clinical Science, Yamaguchi University Graduate School of Medicine, Ube, Yamaguchi, Japan

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `sponsor.collaborators` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.division of cardiology, kyoto university hospital|kyoto|kyoto|japan` — added _(2026-05-12)_
- `locations.division of cardiology, department of medicine and clinical science, yamaguchi university graduate school of medicine|ube|yamaguchi|japan` — added _(2026-05-12)_

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