SMart Angioplasty Research Team: CHoice of Optimal Anti-Thrombotic Strategy in Patients Undergoing Implantation of Coronary Drug-Eluting Stents 3 (SMART-CHOICE3)

January 29, 2025 updated by: Joo-Yong Hahn

Clopidogrel Versus Aspirin Monotherapy After Percutaneous Coronary Intervention and Standard Dual Antiplatelet Therapy in Patients At High Risk for Recurrent Ischemic Events

This study is a prospective, open-label, two-arm, randomized multicenter trial to compare the efficacy and safety of clopidogrel versus aspirin monotherapy beyond the standard duration of dual antiplatelet therapy (DAPT) (more than 12 months for myocardial infarction [MI] and more than 6 months for non-MI) after percutaneous coronary intervention (PCI) in patients at high risk of recurrent ischemic events.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

After the introduction of the second-generation drug-eluting stents (DES), the rates of device-related failure or target lesion failure such as restenosis and stent thrombosis has been markedly decreased, compared with the era of bare-metal stents or first-generation DES. Nevertheless, the risk of ischemic events including very late stent thrombosis after percutaneous coronary intervention (PCI) has still remained even though the use of second-generation DES. In this regard, the ACC (American College of Cardiology)/AHA (American Heart Association) and ESC (European Society of Cardiology) guidelines recommended that dual antiplatelet therapy (DAPT) should be considered for 12 months or longer in patients presented with acute coronary syndrome (ACS) and for 6 months or longer in patients presented with stable ischemic heart disease (SIHD) after PCI with DES. In particular, patients presented with a high risk of ischemic events such as diabetes mellitus, myocardial infarction, or complex coronary lesions were associated with significantly increased future recurrent ischemic events after PCI with DES. In addition, maintenance of DAPT for 12 months or longer has been shown to reduce the recurrence of ischemic events up to 44% in patients treated with PCI for complex coronary artery lesion; therefore the current guideline recommended that prolonged DAPT might be considered when performing complex PCI. However, prolonged DAPT increases bleeding risk and cost. Endoscopic, dental, and surgical procedures are often delayed due to prolonged DAPT, which may affect the patient's quality of life. Therefore, to determine the optimal or minimal necessary duration of DAPT is very important.

The other important issue is that which antiplatelet agent is more appropriate after DAPT. Aspirin monotherapy has been recommended traditionally. However, there is no randomized comparison study between aspirin monotherapy versus clopidogrel monotherapy after DAPT in patients undergoing PCI with DES. Furthermore, clopidogrel is also actively used as a monotherapy after DAPT in real-world practice. In CAPRIE (clopidogrel versus aspirin in patients at risk of ischemic events) trial, clopidogrel showed a superior efficacy in preventing ischemic events compared with aspirin. Moreover, the incidence of gastrointestinal bleeding was significantly lower with clopidogrel than with aspirin. Clopidogrel monotherapy can reduce ischemic events and bleeding risk compared with aspirin monotherapy.

Therefore, the purpose of the SMART-CHOICE 3 (SMart Angioplasty Research Team: CHoice of Optimal Anti-Thrombotic Strategy in Patients Undergoing Implantation of Coronary Drug-Eluting Stents 3) trial is to determine the efficacy and safety of clopidogrel monotherapy compared with aspirin monotherapy beyond the standard duration of DAPT after PCI with current-generation DES in patients at high risk for recurrent ischemic events.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
5506

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

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

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Joo-Yong Hahn, MD, PhD
  • Phone Number: 82-2-3410-1246
  • Email: jyhahn@skku.edu

Study Contact Backup

Study Locations

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Subject must be at least 19 years of age
  2. Patients at high risk of recurrence of ischemic events who have undergone PCI using a DES and are receiving standard DAPT (12 months* or more for myocardial infarction and 6 months* or more for non-myocardial infarction)

  3. Patients at high risk for recurrent ischemic events, which were defined as one or more of the following clinical or lesion characteristics.

    A. Clinical characteristics

    1. Patients with prior myocardial infarction.
    2. Patients with diabetes mellitus who receive oral hypoglycemic agent or insulin.

    B. Complex lesion characteristics Complex lesion was defined as one or more of the following.

    1. True bifurcation lesion (Medina 1,1,1/1,0,1/0,1,1) and is able to assess the side branch ostium
    2. Chronic total occlusion (≥3 months) as target lesion
    3. PCI for unprotected left main disease (left main ostium, body, or distal bifurcation including non-true bifurcation lesions)
    4. Long coronary lesions (implanted stent length ≥38 mm)
    5. Multi-vessel PCI (≥ 2 vessels treated at one PCI session)
    6. Multiple stent needed (≥ 3 stents per patient)
    7. In-stent restenosis lesion as target lesion
    8. Severely calcified lesion (encircling calcium in angiography) i . Ostial lesions of left anterior descending artery, left circumflex artery, or right coronary artery
  4. Subject who is able to understand risks, benefits and treatment alternatives and sign informed consent voluntarily.

Exclusion Criteria:

  1. Known hypersensitivity or contraindications to study medications (aspirin or clopidogrel)
  2. Patients who need continuous anticoagulant therapy.
  3. Patients who require DAPT due to atherosclerotic disease other than coronary artery disease
  4. Patients who are scheduled for revascularization treatment of coronary artery
  5. A patient who are taking single antiplatelet therapy at screening
  6. Pregnant or lactating women
  7. 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)

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Aspirin monotherapy arm
Patients will receive 100 mg of aspirin once daily.
Drug: Aspirin

Randomization will be performed 1:1 between clopidogrel and aspirin monotherapy in patients who completed standard duration of dual antiplatelet therapy (DAPT) and who were at high risk for recurrent ischemic events after percutaneous coronary intervention (PCI) with drug-eluting stent (DES).

This group will be taken aspirin 100 mg once daily during the study period.

Other Names:
  • Aspirin monotherapy
Experimental: Clopidogrel monotherapy arm
Patients will receive 75 mg of clopidogrel once daily.
Drug: Clopidogrel

Randomization will be performed 1:1 between clopidogrel and aspirin monotherapy in patients who completed standard duration of dual antiplatelet therapy (DAPT) and who were at high risk for recurrent ischemic events after percutaneous coronary intervention (PCI) with drug-eluting stent (DES).

This group will be taken clopidogrel 75 mg once daily during the study period.

Other Names:
  • Clopidogrel monotherapy

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Rates of major adverse cardiac and cerebrovascular event (MACCE)
Time Frame: 1-year after last patient enrollment
a composite of all-cause death, myocardial infarction, or stroke
1-year after last patient enrollment

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Rates of all-cause death
Time Frame: 1-year after last patient enrollment
Death by any cause
1-year after last patient enrollment
Rates of myocardial infarction
Time Frame: 1-year after last patient enrollment
Myocardial infarction
1-year after last patient enrollment
Rates of stroke
Time Frame: 1-year after last patient enrollment
Stroke
1-year after last patient enrollment
Rates of stent thrombosis
Time Frame: 1-year after last patient enrollment
definite or probable by Academic Research Consortium [ARC] definition
1-year after last patient enrollment
Rates of all-cause death or MI
Time Frame: 1-year after last patient enrollment
A composite of all-cause death or MI
1-year after last patient enrollment
Rates of major Bleeding
Time Frame: 1-year after last patient enrollment
BARC [Bleeding Academic Research Consortium] types 3 or 5
1-year after last patient enrollment
Rates of bleeding
Time Frame: 1-year after last patient enrollment
BARC [Bleeding Academic Research Consortium] types 2, 3, or 5
1-year after last patient enrollment
Rates of upper gastrointestinal clinical event
Time Frame: 1-year after last patient enrollment
A composite of upper gastrointestinal clinical event
1-year after last patient enrollment
Rates of gastrointestinal ulcer or bleeding
Time Frame: 1-year after last patient enrollment
A composite of gastrointestinal ulcer or bleeding
1-year after last patient enrollment
New diagnosed rates of gastroesophageal reflux disease (GERD)
Time Frame: 1-year after last patient enrollment
Gastroesophageal reflux disease (GERD)
1-year after last patient enrollment
Rates of NACE (Net adverse clinical events)
Time Frame: 1-year after last patient enrollment
MACCE + BARC type 3 or 5 bleeding
1-year after last patient enrollment
Rates of Target-lesion revascularization (TLR)
Time Frame: 1-year after last patient enrollment
Target-lesion revascularization (TLR)
1-year after last patient enrollment
Rates of Target-vessel revascularization (TVR)
Time Frame: 1-year after last patient enrollment
Target-vessel revascularization (TVR)
1-year after last patient enrollment
Rates of any revascularization
Time Frame: 1-year after last patient enrollment
any revascularization including TLR, TVR, and non-TVR re-percutaneous coronary intervention
1-year after last patient enrollment
Medical cost
Time Frame: 1-year after last patient enrollment
Medical cost
1-year after last patient enrollment
Rates of cardiovascular death
Time Frame: 1-year after last patient enrollment
Death by cardiovascular cause
1-year after last patient enrollment
Rates of cardiovascular death or MI
Time Frame: 1-year after last patient enrollment
A composite of cardiovascular death or MI
1-year after last patient enrollment
Rates of cardiovascular death, MI, or stroke
Time Frame: 1-year after last patient enrollment
A composite of cardiovascular death, MI, or stroke
1-year after last patient enrollment
Rates of cardiovascular death, MI, or stent thrombosis
Time Frame: 1-year after last patient enrollment
A composite of cardiovascular death, MI, or stent thrombosis
1-year after last patient enrollment

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Joo-Yong Hahn

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Joo-Yong Hahn, MD, PhD, Samsung Medical Center

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 10, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 31, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 12, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 1, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 2, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 5, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 29, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CHOICE-3

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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