Combined Aspirin Study for Mechanical Prosthetic Valve in Kyushu and Ryukyu by Inter-University Hospital Network (ASPIRIN trial)

UMIN ID: UMIN000010478

Registered date:15/04/2013

Basic Information

• Recruitment status: Complete: follow-up continuing
• Health condition(s) or Problem(s) studied: Valvular heart disease
• Date of first enrollment: 2013/06/01
• Target sample size: 500
• Countries of recruitment: Japan
• Study type: Observational

Outcome(s)

• Primary Outcome: 1) Atherosclerotic events, including stroke, TIA, ischemic heart disease, systemic embolism, peripheral artery disease, and valve thrombosis. 2) Cardiovascular death
• Secondary Outcome: 1) All cause death 2) Hemorrhagic events, including intracranial bleeding, gastrointestinal bleeding, bleeding requiring hospitalization and/or blood transfusion, and other significant bleeding 3) gastroduodenal ulcer

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: 1) Contraindications to anticoagulant therapy 2) Pregnant patients 3) Feeding patients 4) Patients who were considered not adequate to be included in the study by an attending physician

Related Information

• Primary Sponsor: Yutaka Otsuji
• Source(s) of Monetary Support: Japan Society for the Promotion of Science