Extended Japan Assessment of Pitavastatin and Atorvastatin in Acute Coronary Syndrome

NCT01223586 | Completed

• 1 other identifier: H22-42
• Study Type: observational
• Target: 238
• Locations: 1 country
• Sites: 2

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.

Conditions

Statin; Coronary Plaque; Acute Coronary Syndrome; Intravascular Ultrasound; Cardiovascular Events

Outcome Measures

Primary Outcomes (1)

• Composite endpoint

  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

  4-year

Secondary Outcomes (7)

• Composite cardiovascular events

  4-year

• Composite coronary heart disease events

  4-year

• Composite cerebrovascular events

  4-year

• Mortality

  4-year

• Heart disease events

  4-year

Study Arms (2)

Regression

Patients with regression of plaque volume by statin

Non regression

Patients without regression of plaque volume by statin

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Cohort of participants of JAPAN-ACS trial who completed the study

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kyoto University: lead
• Yamaguchi University Hospital: collaborator

Study Sites (2)

Division of Cardiology, Kyoto University Hospital

Kyoto, Kyoto, 606-8507, Japan

Location

Division of Cardiology, Department of Medicine and Clinical Science, Yamaguchi University Graduate School of Medicine

Ube, Yamaguchi, 755-8505, Japan

Location

Related Publications (1)

• 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.

  PMID: 22451449 RESULT

MeSH Terms

Conditions

Acute Coronary Syndrome

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Study Officials

• Masunori Matsuzaki, MD, PhD

  Professor of Division of Cardiology, Department of Medicine and Clinical Science, Yamaguchi University Graduate School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: October 18, 2010
• First Posted: October 19, 2010
• Study Start: November 1, 2010
• Primary Completion: May 1, 2011
• Study Completion: May 1, 2011
• Last Updated: April 24, 2012

Record last verified: 2012-04

Locations

JP (2)