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

JRCT ID: jRCTs031180420

Registered date:22/03/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Coronary Artery Disease
• Date of first enrollment: 13/10/2016
• Target sample size: 1500
• 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: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

-Patients with coronary artery lesion who received PCI using Ultimaster Sirolimus-eluting stent.
-Patient considered appropriate to
discontinue DAPT at 3 month after stent implantation.
-Patients who have provided written informed consent

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: kozuma Ken
• Source(s) of Monetary Support: TERUMO CORPORATION
• Secondary ID(s): NCT02837003