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

T

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

Trial contacts and locations

1

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Central trial contact

Ken Kozuma, MD, PhD

Data sourced from clinicaltrials.gov

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