AzTrials
AzTrials

Coronary Artery DiseaseSMART-CHOICENCT02079194

Comparison Between P2Y12 Antagonist Monotherapy and Dual Antiplatelet Therapy After DES

A study testing P2Y12 antagonist monotherapy and aspirin plus P2Y12 antagonist in people with Coronary Artery Disease, run by Samsung Medical Center at 1 site in South Korea.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Coronary Artery Disease
What is being tested?
P2Y12 antagonist monotherapy and aspirin plus P2Y12 antagonist
Could I receive a placebo?
No, everyone receives an active treatment
How many people
3,000 participants
Where
1 siteSouth Korea
Study dates
18 Mar 2014to 7 Jul 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Cardiac and Vascular Center; Samsung Medical Center

    Seoul, 135-710

Other trials in South Korea

About this study

Official title: 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.

Read the 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.

Being tested
P2Y12 antagonist monotherapy, aspirin plus P2Y12 antagonist
Keywords
Drug-eluting stents, aspirin, P2Y12 antagonist monotherapy
Medical subject headings
Coronary Artery Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • P2Y12 antagonist monotherapyDrug

  • aspirin plus P2Y12 antagonistDrug

Study groups in NCT02079194
Study groupRoleWhat they receive
P2Y12 antagonist monotherapyExperimentalP2Y12 antagonist monotherapy after 3-month DAPT
Receives: Drug: P2Y12 antagonist monotherapy
Aspirin + P2Y12 antagonistExperimentalAspirin + P2Y12 antagonist after 3-month DAPT
Receives: Drug: aspirin plus P2Y12 antagonist

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. A composite of death, myocardial infarction, or cerebrovascular events

    12 months after the index procedure

    Measured: 1 year

Secondary outcomes (11)

  1. All cause Death

    Measured: 1 years

  2. cardiac death

    Measured: 1 years

  3. Myocardial infarction (MI)

    Measured: 1 years

  4. Cerebrovascular accident (CVA)

    Measured: 1 years

  5. Target lesion revascularization (TLR)

    Measured: 1 years

  6. Target vessel revascularization (TVR)

    Measured: 1 years

  7. Any revascularization

    Measured: 1 years

  8. Stent thrombosis: definite or probable stent thrombosis by ARC definition

    Measured: 1 years

  9. BARC bleeding ≥2

    Measured: 1 years

  10. BARC bleeding ≥3

    Measured: 1 years

  11. Major adverse cardiocerebral event (MACCE): death, MI, CVA, or any revascularization

    Measured: 1 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Mar 2014 (estimated)
  2. Study start18 Mar 2014
  3. Primary completion7 Jul 2018
  4. Study completion7 Jul 2020 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
3,000 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02079194
Sponsor's protocol ID
SMC 2014-01-161
Acronym
SMART-CHOICE
Status last verified
Jan 2019
First submitted
3 Mar 2014
Last updated
31 Jan 2019
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 38654565

  • 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.

    PubMed 37987108

  • 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.

    PubMed 36169938

  • 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.

    PubMed 34031020

  • 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.

    PubMed 34011436

  • 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.

    PubMed 33758008

  • 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.

    PubMed 33345567

  • 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.

    PubMed 31237645

  • 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.

    PubMed 29447787

Questions about this trial

What is this clinical trial studying?

A study testing P2Y12 antagonist monotherapy and aspirin plus P2Y12 antagonist in people with Coronary Artery Disease, run by Samsung Medical Center at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 31 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

A composite of death, myocardial infarction, or cerebrovascular events (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02079194, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2019.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in