- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02079194
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
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-
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Seoul, Korea, Republic of, 135-710
- Cardiac and Vascular Center; Samsung Medical Center
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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
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Experimental: Aspirin + P2Y12 antagonist
Aspirin + P2Y12 antagonist after 3-month DAPT
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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
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1 year
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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
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
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
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
Additional Relevant MeSH Terms
- Myocardial Ischemia
- Heart Diseases
- Cardiovascular Diseases
- Vascular Diseases
- Arteriosclerosis
- Arterial Occlusive Diseases
- Coronary Disease
- Coronary Artery Disease
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Fibrinolytic Agents
- Fibrin Modulating Agents
- Platelet Aggregation Inhibitors
- Cyclooxygenase Inhibitors
- Antipyretics
- Aspirin
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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