Coronary Artery Disease
Conditions
Keywords
Drug-Eluting Stent
Brief summary
To evaluate safety of reduction of dual antiplatelet therapy period to three months after implantation of Ultimaster sirolimus-eluting stent (U-SES). Additionally to investigate appropriateness of thienopyridine monotherapy with discontinuation of aspirin.
Interventions
DRUGAspirin
Discontinuation of aspirin at 3 months after the Ultimaster sirolimus-eluting stent implantation by the physician's discretion.
DRUGThienopyridine
Discontinuation of thienopyridine at 3 months after the Ultimaster sirolimus-eluting stent implantation by the physician's discretion.
Sponsors
Teikyo University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with coronary artery lesion who received percutaneous coronary intervention using Ultimaster sirolimus-eluting stent. * Patients considered appropriate to discontinue dual antiplatelet therapy at 3 months after stent implantation. * Patients who have provided written informed consent.
Exclusion criteria
* Patients previously experienced stent thrombosis. * Patients who are unable to clinical follow-up procedure specified in the protocal for the present study. * 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, stroke (ischemic and hemorrhagic), ARC definite/probable stent thrombosis and serious bleeding (BARC 3 or 5). | 12-month |
Secondary
| Measure | Time frame |
|---|---|
| Target lesion revascularization | 3-month |
| Target vessel revascularization | 3-month |
| Readmission related to angina | 3-month |
| Stent thrombosis | 3-month |
| Stent thrombosis (ARC definition) | 12-month |
| Bleeding complications (BARC definition) | 3-month |
| Comparison of event rate by the type of antiplatelet agent | 12-month |
| Major adverse cardiac event | 3-month |
| All cause death | 3-month |
| Cardiac death | 3-month |
| Myocardial infarction | 3-month |
| Stroke (ischemic and hemorrhagic) | 3-month |
| Composite endpoint of all cause death in 3 months, myocardial infarction, stroke (ischemic and hemorrhagic), ARC definite/probable stent thrombosis and serious bleeding (BARC 3 or 5). | 3-month |
Countries
Japan
Contacts
Primary ContactKen Kozuma, MD, PhD
Outcome results
None listed