Acute Coronary Syndrome Clinical Trial
— Ex JAPAN-ACSOfficial title:
Extended Japan Assessment of Pitavastatin and Atorvastatin in Acute Coronary Syndrome
Verified date | April 2012 |
Source | Kyoto University |
Contact | n/a |
Is FDA regulated | No |
Health authority | Japan: Ministry of Health, Labor and Welfare |
Study type | Observational |
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.
Status | Completed |
Enrollment | 238 |
Est. completion date | May 2011 |
Est. primary completion date | May 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 20 Years and older |
Eligibility |
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 |
Observational Model: Cohort, Time Perspective: Retrospective
Country | Name | City | State |
---|---|---|---|
Japan | Division of Cardiology, Kyoto University Hospital | Kyoto | |
Japan | Division of Cardiology, Department of Medicine and Clinical Science, Yamaguchi University Graduate School of Medicine | Ube | Yamaguchi |
Lead Sponsor | Collaborator |
---|---|
Kyoto University | Yamaguchi University Hospital |
Japan,
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 — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Yes |
Secondary | Composite cardiovascular events | Occurrence of one of following events: Cardiovascular death Non-fatal MI Non-fatal CI Unstable angina requiring hospitalizations Ischemia-driven coronary revascularization except target lesion revascularization (TLR) |
4-year | Yes |
Secondary | Composite coronary heart disease events | Occurrence of one of following events: Coronary heart disease (CHD) death Non-fatal MI Unstable angina requiring urgent hospitalizations Ischemia-driven coronary revascularization except TLR |
4-year | Yes |
Secondary | Composite cerebrovascular events | Occurrence of one of following events: Fatal and Non-fatal stroke Transient ischemic attack requiring hospitalizations |
4-year | Yes |
Secondary | Mortality | Occurrence of each following events: All-cause mortality Cardiovascular death Cardiac death (death from coronary disease or heart failure or arrhythmia and sudden death) CHD death (death from myocardial infarction and sudden death) |
4-year | Yes |
Secondary | Heart disease events | Occurrence of each following events: Fatal and Non-fatal MI Non-procedure related MI Procedure related MI Unstable angina requiring urgent hospitalizations Resuscitated cardiac arrest Hospitalization for heart failure PCI or CABG All events of PCI or CABG TLR non-TLR Ischemia-driven PCI or CABG TLR non-TLR |
4-year | Yes |
Secondary | Cerebrovascular events | Occurrence of each following events: Fatal and Non-fatal stroke Fatal and Non-fatal CI Non-procedure related CI Procedure related CI Fatal and Non-fatal cerebral hemorrhage Hospitalization for TIA |
4-year | Yes |
Secondary | Other events | Occurrence of each following events: Operation for or rupture of aortic aneurysm Revascularization for peripheral arterial disease (PAD) Carotid artery stenting (CAS) or carotid endarterectomy (CEA) Aortic dissection Deep vein thrombosis (DVT) or pulmonary thromboembolism (PTE) New occurrence of malignant tumor Operation for aortic stenosis |
4-year | Yes |
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