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

Primary Purpose

Coronary Artery Disease

Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
P2Y12 antagonist monotherapy
aspirin plus P2Y12 antagonist
Sponsored by
Samsung Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease focused on measuring Drug-eluting stents, aspirin, P2Y12 antagonist monotherapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Cardiac and Vascular Center; Samsung Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

P2Y12 antagonist monotherapy

Aspirin + P2Y12 antagonist

Arm Description

P2Y12 antagonist monotherapy after 3-month DAPT

Aspirin + P2Y12 antagonist after 3-month DAPT

Outcomes

Primary Outcome Measures

A composite of death, myocardial infarction, or cerebrovascular events
12 months after the index procedure

Secondary Outcome Measures

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

Full Information

First Posted
March 3, 2014
Last Updated
January 29, 2019
Sponsor
Samsung Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT02079194
Brief Title
Comparison Between P2Y12 Antagonist Monotherapy and Dual Antiplatelet Therapy After DES
Acronym
SMART-CHOICE
Official Title
Comparison Between P2Y12 Antagonist MonotHerapy and Dual Antiplatelet Therapy in Patients UndergOing Implantation of Coronary Drug-Eluting Stents
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Unknown status
Study Start Date
March 18, 2014 (Actual)
Primary Completion Date
July 7, 2018 (Actual)
Study Completion Date
July 7, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Samsung Medical Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
Drug-eluting stents, aspirin, P2Y12 antagonist monotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
3000 (Actual)

8. Arms, Groups, and Interventions

Arm Title
P2Y12 antagonist monotherapy
Arm Type
Experimental
Arm Description
P2Y12 antagonist monotherapy after 3-month DAPT
Arm Title
Aspirin + P2Y12 antagonist
Arm Type
Experimental
Arm Description
Aspirin + P2Y12 antagonist after 3-month DAPT
Intervention Type
Drug
Intervention Name(s)
P2Y12 antagonist monotherapy
Intervention Type
Drug
Intervention Name(s)
aspirin plus P2Y12 antagonist
Primary Outcome Measure Information:
Title
A composite of death, myocardial infarction, or cerebrovascular events
Description
12 months after the index procedure
Time Frame
1 year
Secondary Outcome Measure Information:
Title
All cause Death
Time Frame
1 years
Title
cardiac death
Time Frame
1 years
Title
Myocardial infarction (MI)
Time Frame
1 years
Title
Cerebrovascular accident (CVA)
Time Frame
1 years
Title
Target lesion revascularization (TLR)
Time Frame
1 years
Title
Target vessel revascularization (TVR)
Time Frame
1 years
Title
Any revascularization
Time Frame
1 years
Title
Stent thrombosis: definite or probable stent thrombosis by ARC definition
Time Frame
1 years
Title
BARC bleeding ≥2
Time Frame
1 years
Title
BARC bleeding ≥3
Time Frame
1 years
Title
Major adverse cardiocerebral event (MACCE): death, MI, CVA, or any revascularization
Time Frame
1 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hyeon-Cheol Gwon, MD,PhD
Organizational Affiliation
Samsung Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cardiac and Vascular Center; Samsung Medical Center
City
Seoul
ZIP/Postal Code
135-710
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
36169938
Citation
Choi KH, Park YH, Song YB, Park TK, Lee JM, Yang JH, Choi JH, Choi SH, Oh JH, Chun WJ, Jang WJ, Im ES, Jeong JO, Cho BR, Oh SK, Yun KH, Cho DK, Lee JY, Koh YY, Bae JW, Choi JW, Lee WS, Yoon HJ, Lee SU, Cho JH, Choi WG, Rha SW, Gwon HC, Hahn JY; SMART-CHOICE Investigators. Long-term Effects of P2Y12 Inhibitor Monotherapy After Percutaneous Coronary Intervention: 3-Year Follow-up of the SMART-CHOICE Randomized Clinical Trial. JAMA Cardiol. 2022 Nov 1;7(11):1100-1108. doi: 10.1001/jamacardio.2022.3203.
Results Reference
derived
PubMed Identifier
34031020
Citation
Lee SH, Lee SY, Chun WJ, Song YB, Choi SH, Jeong JO, Oh SK, Yun KH, Koh YY, Bae JW, Choi JW, Gwon HC, Hahn JY. Clopidogrel monotherapy in patients with and without on-treatment high platelet reactivity: a SMART-CHOICE substudy. EuroIntervention. 2021 Dec 3;17(11):e888-e897. doi: 10.4244/EIJ-D-21-00223.
Results Reference
derived
PubMed Identifier
34011436
Citation
Song PS, Park YH, Oh JH, Song YB, Choi SH, Gwon HC, Cho DK, Rha SW, Bae JW, Jeong JO, Hahn JY; SMART-DATE and the SMART-CHOICE investigators. P2Y12 Inhibitor Monotherapy Versus Conventional Dual Antiplatelet Therapy or Aspirin Monotherapy in Acute Coronary Syndrome: A Pooled Analysis of the SMART-DATE and SMART-CHOICE Trials. Am J Cardiol. 2021 Jul 1;150:47-54. doi: 10.1016/j.amjcard.2021.03.053. Epub 2021 May 16.
Results Reference
derived
PubMed Identifier
33758008
Citation
Kim J, Jang WJ, Lee WS, Choi KH, Lee JM, Park TK, Yang JH, Choi JH, Song YB, Choi SH, Gwon HC, Lee SH, Oh JH, Chun WJ, Park YH, Im ES, Jeong JO, Cho BR, Oh SK, Yun KH, Cho DK, Lee JY, Koh YY, Bae JW, Choi JW, Yoon HJ, Lee SU, Cho JH, Choi WG, Rha SW, Hahn JY. P2Y12 inhibitor monotherapy after coronary stenting according to type of P2Y12 inhibitor. Heart. 2021 Mar 23:heartjnl-2020-318821. doi: 10.1136/heartjnl-2020-318821. Online ahead of print.
Results Reference
derived
PubMed Identifier
33345567
Citation
Yun KH, Lee SY, Cho BR, Jang WJ, Song YB, Oh JH, Chun WJ, Park YH, Im ES, Jeong JO, Oh SK, Cho DK, Lee JY, Koh YY, Bae JW, Choi JW, Lee WS, Yoon HJ, Lee SU, Cho JH, Choi WG, Rha SW, Lee JM, Park TK, Yang JH, Choi JH, Choi SH, Lee SH, Gwon HC, Hahn JY; SMART-CHOICE Investigators [Link]. Safety of 3-Month Dual Antiplatelet Therapy After Implantation of Ultrathin Sirolimus-Eluting Stents With Biodegradable Polymer (Orsiro): Results From the SMART-CHOICE Trial. J Am Heart Assoc. 2021 Jan 5;10(1):e018366. doi: 10.1161/JAHA.120.018366. Epub 2020 Dec 21. Erratum In: J Am Heart Assoc. 2021 Mar 16;10(6):e014679.
Results Reference
derived
PubMed Identifier
31237645
Citation
Hahn JY, Song YB, Oh JH, Chun WJ, Park YH, Jang WJ, Im ES, Jeong JO, Cho BR, Oh SK, Yun KH, Cho DK, Lee JY, Koh YY, Bae JW, Choi JW, Lee WS, Yoon HJ, Lee SU, Cho JH, Choi WG, Rha SW, Lee JM, Park TK, Yang JH, Choi JH, Choi SH, Lee SH, Gwon HC; SMART-CHOICE Investigators. Effect of P2Y12 Inhibitor Monotherapy vs Dual Antiplatelet Therapy on Cardiovascular Events in Patients Undergoing Percutaneous Coronary Intervention: The SMART-CHOICE Randomized Clinical Trial. JAMA. 2019 Jun 25;321(24):2428-2437. doi: 10.1001/jama.2019.8146. Erratum In: JAMA. 2019 Oct 1;322(13):1316.
Results Reference
derived
PubMed Identifier
29447787
Citation
Song YB, Oh SK, Oh JH, Im ES, Cho DK, Cho BR, Lee JY, Lee JM, Park TK, Yang JH, Choi JH, Choi SH, Lee SH, Gwon HC, Hahn JY. Rationale and design of the comparison between a P2Y12 inhibitor monotherapy versus dual antiplatelet therapy in patients undergoing implantation of coronary drug-eluting stents (SMART-CHOICE): A prospective multicenter randomized trial. Am Heart J. 2018 Mar;197:77-84. doi: 10.1016/j.ahj.2017.12.002. Epub 2017 Dec 6.
Results Reference
derived

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Comparison Between P2Y12 Antagonist Monotherapy and Dual Antiplatelet Therapy After DES

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