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

Primary Purpose

Coronary Artery Disease

Status
Recruiting
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Aspirin
Clopidogrel
Sponsored by
Joo-Yong Hahn
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease focused on measuring Percutaneous Coronary Intervention, Antiplatelet Therapy, Complex Coronary Lesion, Aspirin, Clopidogrel

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

i) Subject must be at least 19 years of age

ii) Subject who is able to understand risks, benefits and treatment alternatives and sign informed consent voluntarily.

iii) Patients being treated with DAPT at high risk for recurrent ischemic events* who underwent PCI at least 12 months ago.

*High risk for recurrent ischemic events was defined as one or more of the following clinical or lesion characteristics.

A. Clinical characteristics

  1. Patients presented with acute myocardial infarction.
  2. Patients with diabetes mellitus who receiving 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)
  9. Ostial lesions of left anterior descending artery, left circumflex artery, or right coronary artery

Exclusion Criteria:

i) Known hypersensitivity or contraindications to study medications (aspirin or clopidogrel)

ii) Patients taking warfarin or non-vitamin K antagonist (dabigatran, rivaroxaban, edoxaban, or apixaban)

iii) Patients who require DAPT due to atherosclerotic disease other than coronary artery disease

iv) Patients who are scheduled for revascularization treatment of coronary artery

v) Pregnant or lactating women

vi) 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)

Sites / Locations

  • Samsung Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Aspirin monotherapy arm

Clopidogrel monotherapy arm

Arm Description

Patients will receive 100 mg of aspirin once daily.

Patients will receive 75 mg of clopidogrel once daily.

Outcomes

Primary Outcome Measures

Rates of major adverse cardiac and cerebrovascular event (MACCE)
a composite of all-cause death, myocardial infarction, or stroke

Secondary Outcome Measures

Rates of all-cause death
Death by any cause
Rates of cardiac death
Death by cardiac cause
Rates of myocardial infarction
Myocardial infarction
Rates of stroke
Stroke
Rates of stent thrombosis
definite or probable by Academic Research Consortium [ARC] definition
Rates of all-cause death or MI
A composite of all-cause death or MI
Rates of cardiac death or MI
A composite of cardiac death or MI
Rates of cardiac death, MI, or stroke
A composite of cardiac death, MI, or stroke
Rates of cardiac death, MI, or stent thrombosis
A composite of cardiac death, MI, or stent thrombosis
Rates of major Bleeding
BARC [Bleeding Academic Research Consortium] types 3 or 5
Rates of bleeding
BARC [Bleeding Academic Research Consortium] types 2, 3, or 5
Rates of upper gastrointestinal clinical event
A composite of upper gastrointestinal clinical event
Rates of gastrointestinal ulcer or bleeding
A composite of gastrointestinal ulcer or bleeding
New diagnosed rates of gastroesophageal reflux disease (GERD)
Gastroesophageal reflux disease (GERD)
Rates of NACE (Net adverse clinical events)
MACCE + BARC type 3 or 5 bleeding
Rates of Target-lesion revascularization (TLR)
Target-lesion revascularization (TLR)
Rates of Target-vessel revascularization (TVR)
Target-vessel revascularization (TVR)
Rates of any revascularization
any revascularization including TLR, TVR, and non-TVR re-percutaneous coronary intervention
Medical cost
Medical cost

Full Information

First Posted
June 1, 2020
Last Updated
April 12, 2023
Sponsor
Joo-Yong Hahn
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1. Study Identification

Unique Protocol Identification Number
NCT04418479
Brief Title
SMart Angioplasty Research Team: CHoice of Optimal Anti-Thrombotic Strategy in Patients Undergoing Implantation of Coronary Drug-Eluting Stents 3
Acronym
SMART-CHOICE3
Official Title
Clopidogrel Versus Aspirin Monotherapy Beyond Twelve Months After Percutaneous Coronary Intervention in Patients at High Risk for Recurrent Ischemic Events
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 10, 2020 (Actual)
Primary Completion Date
July 31, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Joo-Yong Hahn

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study is prospective, open-label, two-arm, randomized multicenter trial to evaluate the efficacy and safety of clopidogrel monotherapy as compared with aspirin monotherapy beyond 12 months after percutaneous coronary intervention (PCI) with drug-eluting stents (DES) in patients being treated with dual antiplatelet therapy (DAPT) at high risk for recurrent ischemic events.
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 as compared with aspirin monotherapy beyond 12 months after PCI with current-generation DES in patients being treated with DAPT at high risk for recurrent ischemic events.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
Percutaneous Coronary Intervention, Antiplatelet Therapy, Complex Coronary Lesion, Aspirin, Clopidogrel

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
Prospective, open-label, two-arm, randomized controlled trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
5000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Aspirin monotherapy arm
Arm Type
Active Comparator
Arm Description
Patients will receive 100 mg of aspirin once daily.
Arm Title
Clopidogrel monotherapy arm
Arm Type
Experimental
Arm Description
Patients will receive 75 mg of clopidogrel once daily.
Intervention Type
Drug
Intervention Name(s)
Aspirin
Intervention Description
Randomization will be performed 1:1 between clopidogrel and aspirin monotherapy in patients being treated with dual antiplatelet therapy (DAPT) at high risk for recurrent ischemic events who have been over 12 months after percutaneous coronary intervention (PCI) with drug-eluting stent (DES). This group will be taken aspirin 100 mg once daily during the study period.
Intervention Type
Drug
Intervention Name(s)
Clopidogrel
Intervention Description
Randomization will be performed 1:1 between clopidogrel and aspirin monotherapy in patients being treated with dual antiplatelet therapy (DAPT) at high risk for recurrent ischemic events who have been over 12 months after percutaneous coronary intervention (PCI) with drug-eluting stent (DES). This group will be taken clopidogrel 75 mg once daily during the study period.
Primary Outcome Measure Information:
Title
Rates of major adverse cardiac and cerebrovascular event (MACCE)
Description
a composite of all-cause death, myocardial infarction, or stroke
Time Frame
1-year after last patient enrollment
Secondary Outcome Measure Information:
Title
Rates of all-cause death
Description
Death by any cause
Time Frame
1-year after last patient enrollment
Title
Rates of cardiac death
Description
Death by cardiac cause
Time Frame
1-year after last patient enrollment
Title
Rates of myocardial infarction
Description
Myocardial infarction
Time Frame
1-year after last patient enrollment
Title
Rates of stroke
Description
Stroke
Time Frame
1-year after last patient enrollment
Title
Rates of stent thrombosis
Description
definite or probable by Academic Research Consortium [ARC] definition
Time Frame
1-year after last patient enrollment
Title
Rates of all-cause death or MI
Description
A composite of all-cause death or MI
Time Frame
1-year after last patient enrollment
Title
Rates of cardiac death or MI
Description
A composite of cardiac death or MI
Time Frame
1-year after last patient enrollment
Title
Rates of cardiac death, MI, or stroke
Description
A composite of cardiac death, MI, or stroke
Time Frame
1-year after last patient enrollment
Title
Rates of cardiac death, MI, or stent thrombosis
Description
A composite of cardiac death, MI, or stent thrombosis
Time Frame
1-year after last patient enrollment
Title
Rates of major Bleeding
Description
BARC [Bleeding Academic Research Consortium] types 3 or 5
Time Frame
1-year after last patient enrollment
Title
Rates of bleeding
Description
BARC [Bleeding Academic Research Consortium] types 2, 3, or 5
Time Frame
1-year after last patient enrollment
Title
Rates of upper gastrointestinal clinical event
Description
A composite of upper gastrointestinal clinical event
Time Frame
1-year after last patient enrollment
Title
Rates of gastrointestinal ulcer or bleeding
Description
A composite of gastrointestinal ulcer or bleeding
Time Frame
1-year after last patient enrollment
Title
New diagnosed rates of gastroesophageal reflux disease (GERD)
Description
Gastroesophageal reflux disease (GERD)
Time Frame
1-year after last patient enrollment
Title
Rates of NACE (Net adverse clinical events)
Description
MACCE + BARC type 3 or 5 bleeding
Time Frame
1-year after last patient enrollment
Title
Rates of Target-lesion revascularization (TLR)
Description
Target-lesion revascularization (TLR)
Time Frame
1-year after last patient enrollment
Title
Rates of Target-vessel revascularization (TVR)
Description
Target-vessel revascularization (TVR)
Time Frame
1-year after last patient enrollment
Title
Rates of any revascularization
Description
any revascularization including TLR, TVR, and non-TVR re-percutaneous coronary intervention
Time Frame
1-year after last patient enrollment
Title
Medical cost
Description
Medical cost
Time Frame
1-year after last patient enrollment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: i) Subject must be at least 19 years of age ii) Subject who is able to understand risks, benefits and treatment alternatives and sign informed consent voluntarily. iii) Patients being treated with DAPT at high risk for recurrent ischemic events* who underwent PCI at least 12 months ago. *High risk for recurrent ischemic events was defined as one or more of the following clinical or lesion characteristics. A. Clinical characteristics Patients presented with acute myocardial infarction. Patients with diabetes mellitus who receiving 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) Ostial lesions of left anterior descending artery, left circumflex artery, or right coronary artery Exclusion Criteria: i) Known hypersensitivity or contraindications to study medications (aspirin or clopidogrel) ii) Patients taking warfarin or non-vitamin K antagonist (dabigatran, rivaroxaban, edoxaban, or apixaban) iii) Patients who require DAPT due to atherosclerotic disease other than coronary artery disease iv) Patients who are scheduled for revascularization treatment of coronary artery v) Pregnant or lactating women vi) 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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Joo-Yong Hahn, MD, PhD
Phone
82-2-3410-1246
Email
jyhahn@skku.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Ki Hong Choi, MD
Phone
82-2-3410-6653
Email
cardiokh@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joo-Yong Hahn, MD, PhD
Organizational Affiliation
Samsung Medical Center
Official's Role
Study Chair
Facility Information:
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joo-Yong Hahn, MD, PhD
Phone
82-2-3410-6653
Email
ichjy1@gmail.com

12. IPD Sharing Statement

Learn more about this trial

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

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