Observational Registry:Gastrointestinal Complications developed during low-dose aspirin intake or atherothrombosis such as myocardial infarction and cerebral infarction-

UMIN ID: UMIN000000750

Registered date:01/07/2007

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Cerebral infarction, TIA, angina, myocardial infarction, atrial fibrillation
• Date of first enrollment: 2005/01/01
• Target sample size: 1500
• Countries of recruitment: Japan
• Study type: Observational

Outcome(s)

• Primary Outcome: Findings of ulcer, and erosion in upper GI under endoscopy
• Secondary Outcome: Event rate: GI hemorrhage and alternative LANZA score (stomach), Cerebral hemorrhage, Other systematic hemorrhage, cardiovascular death, nonfatal MI, nonfatal cerebrovascular infarction, TIA, Coronary angioplasty /STENT insertion, worsening of primary disease

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 100years-old
• Gender: Male and Female
• Exclude criteria: 1) Serious hepatic or renal disorder with treatment required, 2)Serious lung disorder with treatment required, 3)Pregnant, Possible pregnant, Pregnant desired, 4) Uncontrolled DM, 5)Cancer patient with treatment required, 6)Patient experienced surgery for esophagus, stomach, and duodenal disease, 7)Patient having hypersensitivity against aspirin or other salicylic acids, 8)Patient whom the investigator determined as inadequate

Related Information

• Primary Sponsor: Society for the MAGIC
• Secondary Sponsor: N/A
• Source(s) of Monetary Support: Japan Cardiovascular Research Foundation,N/A