NIPH Clinical Trials Search

UMIN ID: UMIN000001128

Registered date:10/05/2008

A prospective observation study concerning the incidence of atherothrombotic events in patients with acute coronary syndrome.

Basic Information

Recruitment status Complete: follow-up continuing
Health condition(s) or Problem(s) studiedAcute coronary syndrome
Date of first enrollment2008/05/01
Target sample size4000
Countries of recruitmentJapan
Study typeObservational


Primary OutcomeThe incidence of major adverse cardiovascular /cerebrovascular events (MACCE), including vascular death, MI, stroke since baseline to 2 years.
Secondary OutcomeThe incidence of the primary endpoint and each following event are evaluated and the differences of each high-risk patient sub-group are examined. A) Death due to MI B) Death due to stroke C) Other cardiovascular death D) Non-cardiovascular death E) Non-fatal MI, unstable angina F) Non-fatal stroke G) Acute arterial occlusion H) Central retinal artery occlusion I) Coronary revascularization due to myocardial ischemia J) Hospitalization due to HF K) Hospitalization due to TIA L) Hospitalization due to revascularization M) Hemorrhages requiring hospitalization or blood transfusion N) Other adverse events requiring hospitalization O) Target Vessel Failure

Key inclusion & exclusion criteria

Age minimum20years-old
Age maximumNot applicable
GenderMale and Female
Include criteria
Exclude criteriaPatients meeting any of the following criteria will be excluded from the study. 1) Chest pain and coronary diseases developed in association with other serious diseases or their treatments (e.g.: myocardial infarctions associated with car accidents, traumas, serious gastrointestinal hemorrhage or associated with vascular intervention or coronary bypass surgery) 2) Inpatients not intended for close examination/treatment of chest pain 3) Patients who are sub acute stent-thrombosis 4) Patients aged less than 20 years 5) Patients not providing a written consent by themselves or their family members 6) Patients who are disqualified the study by the investigators

Related Information


public contact
Address Japan
Telephone 0120-303-806
Affiliation PACIFIC Helpdesk Mebix Inc.
scientific contact
Name Hiroyuki Daida
Address 2-1-1, Hongo, Bunkyo-Ku, Tokyo, 113-8421, Japan Japan
Telephone 03-3813-3111
Affiliation Juntendo University Division of Cardiology, Department of Internal Medicine