NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JRCT ID: jRCTs031180420

Registered date:22/03/2019

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

Basic Information

Recruitment status Complete
Health condition(s) or Problem(s) studiedCoronary Artery Disease
Date of first enrollment13/10/2016
Target sample size1500
Countries of recruitmentJapan
Study typeInterventional
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 Outcomecomposite 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 maximumNot applicable
GenderBoth
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

Contact

Public contact
Name Ken kozuma
Address 2-11-1,Kaga,Itabashi-ku,Tokyo Tokyo Japan 173-8606
Telephone +81-3-3964-1211
E-mail PXE00364@nifty.com
Affiliation Teikyo University Hospital.
Scientific contact
Name Ken kozuma
Address 2-11-1,Kaga,Itabashi-ku,Tokyo Tokyo Japan 173-8606
Telephone +81-3-3964-1211
E-mail PXE00364@nifty.com
Affiliation Teikyo University Hospital.