An observational study in Coronary Artery Disease, sponsored by Teikyo University. Status unknown at 1 site in Japan. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2016-08-02.
Sponsored by Teikyo University · Observational
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.
5,596 studies on the registry are indexed under Coronary Artery Disease; 955 are open to participants now.
This study's planned enrollment of 1,500 is above the median of 336 across 1,946 observational studies indexed under Coronary Artery Disease.
Browse Coronary Artery Disease studies →Teikyo University is the lead sponsor of 4 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
The present study consisted of the following two study arms: the 3-month DAPT arm, a new registry arm in which 1,500 patients are consecutively recruite at 72 medical institutions; and the Longer DAPT arm, a historical control arm that consisted of 1,123 patients at 58 medical institutions.
Exclusion Criteria:
Aspirin treatment for 3 months after the Ultimaster sirolimus-eluting stent implantation.
Drug: Aspirin
Thienopyridine treatment for 3 months after the Ultimaster sirolimus-eluting Stent implantation.
Drug: Thienopyridine
Discontinuation of aspirin at 3 months after the Ultimaster sirolimus-eluting stent implantation by the physician's discretion.
Discontinuation of thienopyridine at 3 months after the Ultimaster sirolimus-eluting stent implantation by the physician's discretion.
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).
Time frame: 12-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).
Time frame: 3-month
Major adverse cardiac event
Time frame: 3-month
Major adverse cardiac event
Time frame: 12-month
All cause death
Time frame: 3-month
All cause death
Time frame: 12-month
Cardiac death
Time frame: 3-month
Cardiac death
Time frame: 12-month
Myocardial infarction
Time frame: 3-month
Myocardial infarction
Time frame: 12-month
Stroke (ischemic and hemorrhagic)
Time frame: 3-month
Stroke (ischemic and hemorrhagic)
Time frame: 12-month
Target lesion revascularization
Time frame: 3-month
Target lesion revascularization
Time frame: 12-month
Target vessel revascularization
Time frame: 3-month
Target vessel revascularization
Time frame: 12-month
Readmission related to angina
Time frame: 3-month
Readmission related to angina
Time frame: 12-month
Stent thrombosis
Time frame: 3-month
Stent thrombosis (ARC definition)
Time frame: 12-month
Bleeding complications (BARC definition)
Time frame: 3-month
Bleeding complications (BARC definition)
Time frame: 12-month
Comparison of event rate by the type of antiplatelet agent
Time frame: 12-month
This study is status unknown, as verified in Jul 2016. You cannot join it, but the record below documents what was studied.
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Teikyo University