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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000022695

Enrollment

1500

Registered

2016-06-10

Start date

2016-09-27

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Artery Disease

Interventions

Discontinuation of aspirin or thienopyridine at 3 months after the Ultimaster sirolimus-eluting stent implantation by the physician&#39

s discretion.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: -Patients with coronary artery lesion who received PCI using U-SES. -Patient considered appropriate to discontinue DAPT at 3 month after stent implantation. -Patients who have provided written informed consent

Exclusion criteria

Exclusion 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.

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
- 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	—

Measure

Time frame

- 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

—

Countries

Japan

Contacts

Public ContactYukihisa Hanawa

Meditrix Corporation MODEL U-SES Administrative Office

yukihisa.hanawa@meditrix.jp03-6261-5111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026