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

NCT04418479 | Completed Phase 4 DMC

• 1 other identifier: CHOICE-3
• Study Type: interventional
• Target: 5,506
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Coronary Artery Disease

Keywords

Percutaneous Coronary Intervention; Antiplatelet Therapy; Complex Coronary Lesion; Aspirin; Clopidogrel

Outcome Measures

Primary Outcomes (1)

• Rates of major adverse cardiac and cerebrovascular event (MACCE)

  a composite of all-cause death, myocardial infarction, or stroke

  1-year after last patient enrollment

Secondary Outcomes (19)

• Rates of all-cause death

  1-year after last patient enrollment

• Rates of cardiovascular death

  1-year after last patient enrollment

• Rates of myocardial infarction

  1-year after last patient enrollment

• Rates of stroke

  1-year after last patient enrollment

• Rates of stent thrombosis

  1-year after last patient enrollment

Study Arms (2)

Aspirin monotherapy arm

ACTIVE COMPARATOR

Patients will receive 100 mg of aspirin once daily.

Drug: Aspirin

Clopidogrel monotherapy arm

EXPERIMENTAL

Patients will receive 75 mg of clopidogrel once daily.

Drug: Clopidogrel

Interventions

Aspirin DRUG

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.

Also known as: Aspirin monotherapy

Aspirin monotherapy arm

Clopidogrel DRUG

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.

Also known as: Clopidogrel monotherapy

Clopidogrel monotherapy arm

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject must be at least 19 years of age
• 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)
• 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
• Patients with prior myocardial infarction.
• 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.
• True bifurcation lesion (Medina 1,1,1/1,0,1/0,1,1) and is able to assess the side branch ostium
• Chronic total occlusion (≥3 months) as target lesion
• PCI for unprotected left main disease (left main ostium, body, or distal bifurcation including non-true bifurcation lesions)
• Long coronary lesions (implanted stent length ≥38 mm)
• Multi-vessel PCI (≥ 2 vessels treated at one PCI session)
• Multiple stent needed (≥ 3 stents per patient)
• In-stent restenosis lesion as target lesion
• Severely calcified lesion (encircling calcium in angiography) i . Ostial lesions of left anterior descending artery, left circumflex artery, or right coronary artery

You may not qualify if:

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

Sponsors & Collaborators

• Joo-Yong Hahn: lead

Study Sites (1)

Samsung Medical Center

Seoul, 06351, South Korea

Location

Related Publications (1)

• Choi KH, Park YH, Lee JY, Jeong JO, Kim CJ, Yun KH, Lee HC, Chang K, Park MW, Bae JW, Doh JH, Cho BR, Kim HY, Kim W, Kim U, Rha SW, Hong YJ, Lee HJ, Ahn SG, Kim DI, Cho JH, Her SH, Jeon DS, Han SH, Lee JB, Lee CW, Kang D, Lee JM, Park TK, Yang JH, Lee SY, Choi SH, Gwon HC, Song YB, Hahn JY; SMART-CHOICE 3 investigators. Efficacy and safety of clopidogrel versus aspirin monotherapy in patients at high risk of subsequent cardiovascular event after percutaneous coronary intervention (SMART-CHOICE 3): a randomised, open-label, multicentre trial. Lancet. 2025 Apr 12;405(10486):1252-1263. doi: 10.1016/S0140-6736(25)00449-0. Epub 2025 Mar 30.

  PMID: 40174599 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Aspirin; Clopidogrel

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Ticlopidine; Thienopyridines; Thiophenes; Sulfur Compounds; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Joo-Yong Hahn, MD, PhD

  Samsung Medical Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Model Details: Prospective, open-label, two-arm, randomized controlled trial

Study Record Dates

• First Submitted: June 1, 2020
• First Posted: June 5, 2020
• Study Start: August 10, 2020
• Primary Completion: October 31, 2024
• Study Completion: November 12, 2024
• Last Updated: January 30, 2025

Record last verified: 2025-01

Locations

KR (1)