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

Teikyo University1,500 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

1,500

Conditions

Coronary Artery Disease

Interventions

AspirinDRUG

Discontinuation of aspirin at 3 months after the Ultimaster sirolimus-eluting stent implantation by the physician's discretion.

ThienopyridineDRUG

Discontinuation of thienopyridine at 3 months after the Ultimaster sirolimus-eluting stent implantation by the physician's discretion.

Eligibility

Sex: ALLMin age: 20 Years

Medical Language ↔ Plain English

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.

Locations (1)

Teikyo University Hospital

Tokyo, Japan

RECRUITING

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

Central Contacts

Ken Kozuma, MD, PhD

CONTACT

+81-3-3964-1211 PXE00364@nifty.com

Data from ClinicalTrials.gov

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