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

January 29, 2019 updated by: Hyeon-Cheol Gwon, Samsung Medical Center

Comparison Between P2Y12 Antagonist MonotHerapy and Dual Antiplatelet Therapy in Patients UndergOing Implantation of Coronary Drug-Eluting Stents

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

3000

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 135-710
        • Cardiac and Vascular Center; Samsung Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: P2Y12 antagonist monotherapy
P2Y12 antagonist monotherapy after 3-month DAPT
Drug: P2Y12 antagonist monotherapy
Experimental: Aspirin + P2Y12 antagonist
Aspirin + P2Y12 antagonist after 3-month DAPT
Drug: aspirin plus P2Y12 antagonist

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
A composite of death, myocardial infarction, or cerebrovascular events
Time Frame: 1 year
12 months after the index procedure
1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
All cause Death
Time Frame: 1 years
1 years
cardiac death
Time Frame: 1 years
1 years
Myocardial infarction (MI)
Time Frame: 1 years
1 years
Cerebrovascular accident (CVA)
Time Frame: 1 years
1 years
Target lesion revascularization (TLR)
Time Frame: 1 years
1 years
Target vessel revascularization (TVR)
Time Frame: 1 years
1 years
Any revascularization
Time Frame: 1 years
1 years
Stent thrombosis: definite or probable stent thrombosis by ARC definition
Time Frame: 1 years
1 years
BARC bleeding ≥2
Time Frame: 1 years
1 years
BARC bleeding ≥3
Time Frame: 1 years
1 years
Major adverse cardiocerebral event (MACCE): death, MI, CVA, or any revascularization
Time Frame: 1 years
1 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Samsung Medical Center

Investigators

  • Principal Investigator: Hyeon-Cheol Gwon, MD,PhD, Samsung Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 18, 2014

Primary Completion (Actual)

July 7, 2018

Study Completion (Anticipated)

July 7, 2020

Study Registration Dates

First Submitted

March 3, 2014

First Submitted That Met QC Criteria

March 4, 2014

First Posted (Estimate)

March 5, 2014

Study Record Updates

Last Update Posted (Actual)

January 31, 2019

Last Update Submitted That Met QC Criteria

January 29, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SMC 2014-01-161

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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