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

• Conditions: Coronary Artery Disease
• Interventions: Drug: Thienopyridine; Drug: Aspirin

• Registration Number: NCT02837003
• Lead Sponsor: Teikyo University

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2016-07
• Study Start: 2016-07
• Study First Submitted: 2016-07-08
• Study First Submitted QC: 2016-07-14
• Study First Posted: 2016-07-19
• Last Update Submitted: 2016-07-31
• Last Update Posted: 2016-08-02
• Primary Completion: 2019-03
• Study Completion: 2019-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1500

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Experimental: Thienopyridine	Thienopyridine	Thienopyridine treatment for 3 months after the Ultimaster sirolimus-eluting Stent implantation.
Experimental: Aspirin	Aspirin	Aspirin treatment for 3 months after the Ultimaster sirolimus-eluting stent implantation.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
Major adverse cardiac event	12-month
All cause death	12-month
Cardiac death	12-month
Myocardial infarction	12-month
Stroke (ischemic and hemorrhagic)	12-month
Target lesion revascularization	12-month
Target vessel revascularization	12-month
Readmission related to angina	12-month
Stent thrombosis	3-month
Stent thrombosis (ARC definition)	12-month
Bleeding complications (BARC definition)	12-month
Comparison of event rate by the type of antiplatelet agent	12-month

Trial Locations

Locations (1)

Teikyo University Hospital; 🇯🇵 Tokyo, Japan