3-Month Discontinuation of Dual Antiplatelet Therapy After Ultimaster Sirolimus-Eluting Stent Implantation (MODEL U-SES)

Teikyo University

Status: Unknown

Conditions: Coronary Artery Disease

Treatments: Drug: Thienopyridine; Drug: Aspirin

Study type: Observational

Funder types: Other

Identifiers

NCT02837003

MODEL U-SES

Details and patient eligibility

About

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.

Enrollment: 1,500 estimated patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

1,500 participants in 2 patient groups

Experimental: Aspirin

Description:

Aspirin treatment for 3 months after the Ultimaster sirolimus-eluting stent implantation.

Treatment:

Drug: Aspirin

Experimental: Thienopyridine

Description:

Thienopyridine treatment for 3 months after the Ultimaster sirolimus-eluting Stent implantation.

Treatment:

Drug: Thienopyridine