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

UMIN ID: UMIN000001128

Registered date:10/05/2008

Basic Information

• Recruitment status: Complete: follow-up continuing
• Health condition(s) or Problem(s) studied: Acute coronary syndrome
• Date of first enrollment: 2008/05/01
• Target sample size: 4000
• Countries of recruitment: Japan
• Study type: Observational

Outcome(s)

• Primary Outcome: The incidence of major adverse cardiovascular /cerebrovascular events (MACCE), including vascular death, MI, stroke since baseline to 2 years.
• Secondary Outcome: The 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 minimum: 20years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: Patients 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

• Primary Sponsor: Sanofi K.K.
• Source(s) of Monetary Support: Sanofi K.K.