NCT02079194

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
3,000

participants targeted

Target at P75+ for not_applicable coronary-artery-disease

Timeline
Completed

Started Mar 2014

Longer than P75 for not_applicable coronary-artery-disease

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 3, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 5, 2014

Completed
13 days until next milestone

Study Start

First participant enrolled

March 18, 2014

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 7, 2018

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 7, 2020

Completed
Last Updated

January 31, 2019

Status Verified

January 1, 2019

Enrollment Period

4.3 years

First QC Date

March 3, 2014

Last Update Submit

January 29, 2019

Conditions

Coronary Artery Disease

Keywords

Drug-eluting stentsaspirinP2Y12 antagonist monotherapy

Outcome Measures

Primary Outcomes (1)

  • A composite of death, myocardial infarction, or cerebrovascular events

    12 months after the index procedure

    1 year

Secondary Outcomes (11)

  • All cause Death

    1 years

  • cardiac death

    1 years

  • Myocardial infarction (MI)

    1 years

  • Cerebrovascular accident (CVA)

    1 years

  • Target lesion revascularization (TLR)

    1 years

  • +6 more secondary outcomes

Study Arms (2)

P2Y12 antagonist monotherapy

EXPERIMENTAL

P2Y12 antagonist monotherapy after 3-month DAPT

Drug: P2Y12 antagonist monotherapy

Aspirin + P2Y12 antagonist

EXPERIMENTAL

Aspirin + P2Y12 antagonist after 3-month DAPT

Drug: aspirin plus P2Y12 antagonist

Interventions

P2Y12 antagonist monotherapyDRUG
P2Y12 antagonist monotherapy
aspirin plus P2Y12 antagonistDRUG
Aspirin + P2Y12 antagonist

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cardiac and Vascular Center; Samsung Medical Center

Seoul, 135-710, South Korea

Location

Related Publications (9)

  • Song PS, Seong SW, Kim JY, An SY, Kim MJ, Ahn KT, Jin SA, Jeong JO, Yang JH, Hahn JY, Gwon HC, Jang WJ, Yoon HJ, Bae JW, Choi WG, Song YB. The Association of CHADS-P2A2RC Risk Score With Clinical Outcomes in Patients Taking P2Y12 Inhibitor Monotherapy After 3 Months of Dual Antiplatelet Therapy Following Percutaneous Coronary Intervention. Korean Circ J. 2024 Apr;54(4):189-200. doi: 10.4070/kcj.2023.0268.

    PMID: 38654565DERIVED

  • Shin ES, Her AY, Kim B, Hahn JY, Song YB, Lee JM, Park TK, Yang JH, Choi JH, Choi SH, Lee SH, Gwon HC; SMART-CHOICE Investigators. Sex-Based Outcomes of P2Y12 Inhibitor Monotherapy After Three Months of Dual Antiplatelet Therapy in Patients Undergoing Percutaneous Coronary Intervention. J Korean Med Sci. 2023 Nov 20;38(45):e383. doi: 10.3346/jkms.2023.38.e383.

    PMID: 37987108DERIVED

  • 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.

    PMID: 36169938DERIVED

  • 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.

    PMID: 34031020DERIVED

  • 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.

    PMID: 34011436DERIVED

  • 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 Jun 11;107(13):1077-1083. doi: 10.1136/heartjnl-2020-318821.

    PMID: 33758008DERIVED

  • 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.

    PMID: 33345567DERIVED

  • 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.

    PMID: 31237645DERIVED

  • 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.

    PMID: 29447787DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Aspirin

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

SalicylatesHydroxybenzoatesPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Officials

  • Hyeon-Cheol Gwon, MD,PhD

    Samsung Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 3, 2014

First Posted

March 5, 2014

Study Start

March 18, 2014

Primary Completion

July 7, 2018

Study Completion

July 7, 2020

Last Updated

January 31, 2019

Record last verified: 2019-01

Locations

KR(1)