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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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04418479
Recruitment Status : Not yet recruiting
First Posted : June 5, 2020
Last Update Posted : June 5, 2020
Sponsor:
Information provided by (Responsible Party):
Joo-Yong Hahn, Samsung Medical Center

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.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Drug: Aspirin Drug: Clopidogrel Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 5000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Prospective, open-label, two-arm, randomized controlled trial
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clopidogrel Versus Aspirin Monotherapy Beyond Twelve Months After Percutaneous Coronary Intervention in Patients at High Risk for Recurrent Ischemic Events
Estimated Study Start Date : July 1, 2020
Estimated Primary Completion Date : June 30, 2024
Estimated Study Completion Date : December 31, 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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 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.


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 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 Measures :
  1. 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


Secondary Outcome Measures :
  1. Rates of all-cause death [ Time Frame: 1-year after last patient enrollment ]
    Death by any cause

  2. Rates of cardiac death [ Time Frame: 1-year after last patient enrollment ]
    Death by cardiac cause

  3. Rates of myocardial infarction [ Time Frame: 1-year after last patient enrollment ]
    Myocardial infarction

  4. Rates of stroke [ Time Frame: 1-year after last patient enrollment ]
    Stroke

  5. Rates of stent thrombosis [ Time Frame: 1-year after last patient enrollment ]
    definite or probable by Academic Research Consortium [ARC] definition

  6. Rates of all-cause death or MI [ Time Frame: 1-year after last patient enrollment ]
    A composite of all-cause death or MI

  7. Rates of cardiac death or MI [ Time Frame: 1-year after last patient enrollment ]
    A composite of cardiac death or MI

  8. Rates of cardiac death, MI, or stroke [ Time Frame: 1-year after last patient enrollment ]
    A composite of cardiac death, MI, or stroke

  9. Rates of cardiac death, MI, or stent thrombosis [ Time Frame: 1-year after last patient enrollment ]
    A composite of cardiac death, MI, or stent thrombosis

  10. Rates of major Bleeding [ Time Frame: 1-year after last patient enrollment ]
    BARC [Bleeding Academic Research Consortium] types 3 or 5

  11. Rates of bleeding [ Time Frame: 1-year after last patient enrollment ]
    BARC [Bleeding Academic Research Consortium] types 2, 3, or 5

  12. Rates of upper gastrointestinal clinical event [ Time Frame: 1-year after last patient enrollment ]
    A composite of upper gastrointestinal clinical event

  13. Rates of gastrointestinal ulcer or bleeding [ Time Frame: 1-year after last patient enrollment ]
    A composite of gastrointestinal ulcer or bleeding

  14. New diagnosed rates of gastroesophageal reflux disease (GERD) [ Time Frame: 1-year after last patient enrollment ]
    Gastroesophageal reflux disease (GERD)

  15. Rates of NACE (Net adverse clinical events) [ Time Frame: 1-year after last patient enrollment ]
    MACCE + BARC type 3 or 5 bleeding

  16. Rates of Target-lesion revascularization (TLR) [ Time Frame: 1-year after last patient enrollment ]
    Target-lesion revascularization (TLR)

  17. Rates of Target-vessel revascularization (TVR) [ Time Frame: 1-year after last patient enrollment ]
    Target-vessel revascularization (TVR)

  18. Rates of any revascularization [ Time Frame: 1-year after last patient enrollment ]
    any revascularization including TLR, TVR, and non-TVR re-percutaneous coronary intervention

  19. Medical cost [ Time Frame: 1-year after last patient enrollment ]
    Medical cost



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

  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)


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04418479


Contacts
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Contact: Joo-Yong Hahn, MD, PhD 82-2-3410-1246 jyhahn@skku.edu
Contact: Ki Hong Choi, MD 82-2-3410-6653 cardiokh@gmail.com

Sponsors and Collaborators
Samsung Medical Center
Investigators
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Study Chair: Joo-Yong Hahn, MD, PhD Samsung Medical Center
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Responsible Party: Joo-Yong Hahn, Professor, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT04418479    
Other Study ID Numbers: CHOICE-3
First Posted: June 5, 2020    Key Record Dates
Last Update Posted: June 5, 2020
Last Verified: June 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Joo-Yong Hahn, Samsung Medical Center:
Percutaneous Coronary Intervention
Antiplatelet Therapy
Complex Coronary Lesion
Aspirin
Clopidogrel
Additional relevant MeSH terms:
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Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Aspirin
Clopidogrel
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents