Comparison Between P2Y12 Antagonist Monotherapy and Dual Antiplatelet Therapy After DES (SMART-CHOICE)

Samsung Medical Center

Status

Unknown

Conditions

Coronary Artery Disease

Treatments

Drug: P2Y12 antagonist monotherapy

Drug: aspirin plus P2Y12 antagonist

Study type

Interventional

Funder types

Other

Identifiers

NCT02079194

SMC 2014-01-161

Details and patient eligibility

About

To compare the efficacy and safety of clopidogrel monotherapy versus aspirin plus P2Y12 antagonist following 3-month of DAPT in patients undergoing PCI with DES.

Full description

This trial is a prospective, randomized, multi-center, open label, noninferiority trial. Patients undergoing PCI with DES will be eligible. After successful PCI with DES, all eligible patients will be randomized either to clopidogrel monotherapy or to aspirin plus P2Y12 antagonist following 3-month of DAPT.

Enrollment

3,000 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Subject must be at least 20 years of age.
Subject is able to verbally confirm understandings of risks, benefits and treatment alternatives and he/she or his/her legally authorized representative provides written informed consent prior to any study related procedure.
Patients undergoing successful PCI

Exclusion criteria

Hemodynamic instability or cardiogenic shock
Active bleeding
Known hypersensitivity or contraindication to study medications
Female of childbearing potential, unless a recent pregnancy test is negative, who possibly plan to become pregnant any time after enrollment into this study
Non-cardiac co-morbid conditions are present with life expectancy <2 year or that may result in protocol non-compliance (per site investigator's medical judgment).
DES implantation within 12 months before index procedure