3-Month Discontinuation of Dual Antiplatelet Therapy after Ultimaster Sirolimus-Eluting Stent Implantation

UMIN ID: UMIN000022695

Registered date:10/06/2016

Basic Information

• Recruitment status: Complete: follow-up continuing
• Health condition(s) or Problem(s) studied: Coronary Artery Disease
• Date of first enrollment: 2016/09/27
• Target sample size: 1500
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): Discontinuation of aspirin or thienopyridine at 3 months after the Ultimaster sirolimus-eluting stent implantation by the physician's discretion.

Outcome(s)

• Primary Outcome: composite endpoint of all cause death in 12 months, myocardial infarction (MI), stroke (ischemic and hemorrhagic), ARC Definite / Probable stent thrombosis and serious bleeding (BARC 3 or 5).
• Secondary Outcome: - composite endpoint of all cause death in 3 months, myocardial infarction (MI), stroke (ischemic and hemorrhagic), ARC Definite/Probable stent thrombosis and serious bleeding (BARC 3 or 5). - MACE - All cause death - Cardiac death - MI - Stroke(ischemic and hemorrhagic) - TVR - TLR - Readmission related to Angina - TIA - Stent thrombosis -Bleeding complications (BARC definition) - comparison of event rate by the type of antiplatelet agent

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: - Patients previously experienced stent thrombosis - Patients who are unable to follow up - Patients who are enrolled or planned to participate in another clinical trials of antiplatelet therapy.

Related Information

• Primary Sponsor: Teikyo University Hospital
• Source(s) of Monetary Support: Terumo Corporation