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P2Y12 Inhibitor Monotherapy Versus Extended DAPT in Patients Treated With Bioresorbable Scaffold (SMART-CHOICEII)

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ClinicalTrials.gov Identifier: NCT03119012
Recruitment Status : Recruiting
First Posted : April 18, 2017
Last Update Posted : April 9, 2019
Sponsor:
Information provided by (Responsible Party):
Joo-Yong Hahn, Samsung Medical Center

Study Description
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Brief Summary:
This study aimed to compare the efficacy and safety of P2Y12 inhibitor monotherapy versus extended dual antiplatelet therapy (DAPT) following 12-month of DAPT in patients undergoing percutaneous coronary intervention (PCI) with bioresorbable scaffold (BRS)

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

Detailed Description:

After the development of second generation drug-eluting stent (DES), clinical outcomes including in-stent restenosis have been dramatically improved in patients with coronary artery disease undergoing percutaneous coronary intervention (PCI) compared with bare metal stent or first generation DES era. However, interventional cardiologist still concern about late adverse cardiac events including stent thrombosis (ST) in patients who received implantation of permanent metallic stent. Bioresorbable scaffold (BRS) have been developed to provide mechanical support and drug-delivery function similar to those of DES for approximately 1 year, followed by complete bioresorption over several years. It has the advantages of reducing the risk of late ST and maintaining of normal vascular function because these novel devices are expected to leave no permanent materials within the vessel. Although there was no significant difference from previous randomized controlled studies for evaluating the clinical outcomes at 1-year between BRS and DES, recently documented ARSORB II trial, which compared 3-year outcomes between BRS and DES, show that patients treated with BRS had a higher risk of device-oriented composite endpoint mainly driven by target vessel myocardial infarction (MI) compared to those with DES. In addition, in several case reports, the late ST after discontinuation of dual anti-platelet therapy (DAPT) was reported in patients who underwent BRS implantation. Therefore, the efficacy of extended DAPT and needs for optimal DAPT duration in patients treated with BRS have been emerged. In the DAPT study, randomized controlled trial including approximately 10,000 patients, DAPT beyond 1 year after placement of a DES, as compared with aspirin therapy alone, significantly reduced the risks of major adverse cardiovascular and cerebrovascular events (MACCE) and ST. However, extend use of DAPT increases bleeding risk and cost. Endoscopic, dental, and surgical procedures are often delayed due to extended DAPT, which may affect the patient's quality of life. In addition, there was no significant difference in all-cause mortality between extended DAPT and aspirin monotherapy in the DAPT study because of increased bleeding risk in extended DAPT group. 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. In CAPRIE (Clopidogrel versus Aspirin in Patients at Risk of Ischaemic Events) trial, clopidogrel showed a superior efficacy in preventing ischemic events compared with aspirin and the incidence of gastrointestinal bleeding was significantly lower with clopidogrel than with aspirin. Moreover, clopidogrel monotherapy was associated with a reduced risk of ischemic events without increased bleeding risk compared with aspirin monotherapy in patients receiving DES after 12-month DAPT. However, current guidelines still recommend aspirin monotherapy after 6-12 months of DAPT in patients treated with DES, there were no data for evaluating the optimal duration of DAPT and preferred choice of monotherapy in patients treated with BRS. Through results of previous studies, the authors postulated that P2Y12 antagonist monotherapy, which might have superior ability to prevent ischemic event compared to aspirin monotherapy, had similar risk of ischemic events with lower risk of bleeding complication compared with extended DAPT in patients who received BRS implantation with 12-month DAPT. Therefore, in the SMART-CHOICE II trial, we will test noninferiority of P2Y12 antagonist monotherapy compared with aspirin plus P2Y12 antagonist after 12-month of DAPT in patients treated with BRS.

Stratification: presence of diabetes mellitus, clinical presentation (acute coronary syndrome), type of P2Y12 inhibitor (clopidogrel or ticagrelor), and investigational center.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1520 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: SMart Angioplasty Research Team: Comparison Between P2Y12 Inhibitor MonotHerapy and Dual Antiplatelet Therapy in Patients UndergOing Implantation of Coronary BiorEsorbable Scaffold II: (SMART-CHOICE II) Trial
Actual Study Start Date : April 19, 2017
Estimated Primary Completion Date : April 2022
Estimated Study Completion Date : April 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: P2Y12 receptor inhibitor monotherapy arm
In patients who do not occur a MACCE until 12-month after BRS implantation, P2Y12 receptor inhibitor monotherapy arm will be received clopidogrel 75mg qd or ticagrelor 60mg bid during follow-up period (24 months after randomization).
 Drug: Clopidogrel
75mg/day
Other Name: Clopidogrel or its generic

Drug: Ticagrelor
120mg/day
Other Name: Brillinta
Active Comparator: Extended DAPT arm
In patients who do not occur a MACCE until 12-month after BRS implantation, Extended DAPT arm will be received aspirin 100mg qd plus P2Y12 receptor inhibitor (clopidogrel 75mg qd or ticagrelor 60mg bid) during follow-up period (24 months after randomization).
 Drug: Clopidogrel
75mg/day
Other Name: Clopidogrel or its generic

Drug: Ticagrelor
120mg/day
Other Name: Brillinta

Drug: Aspirin
100mg/day
Other Name: Any commercially available aspirin


Outcome Measures
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Primary Outcome Measures :
  1. A composite of death, myocardial infarction, and cerebrovascular events [ Time Frame: 36 months after the index procedure ]
    defined as MACCE


Secondary Outcome Measures :
  1. All-cause death [ Time Frame: 36 months after the index procedure ]
    Any death

  2. Cardiac death [ Time Frame: 36 months after the index procedure ]
    ARC definition

  3. Myocardial infarction [ Time Frame: 36 months after the index procedure ]
    ARC definition

  4. Cerebrovascular accident [ Time Frame: 36 months after the index procedure ]
    ischemic and hemorrhagic

  5. target lesion revascularization (TLR) [ Time Frame: 36 months after the index procedure ]
    ischemic driven or all

  6. Target vessel revascularization (TVR) [ Time Frame: 36 months after the index procedure ]
    ischemic driven or all

  7. Any revascularization [ Time Frame: 36 months after the index procedure ]
    ischemic driven or all

  8. Stent thrombosis (ST) [ Time Frame: 36 months after the index procedure ]
    definite or probable ST by Academic Research Consortium (ARC) definition

  9. Bleeding Academic Research Consortium (BARC) bleeding 2,3, or 5 [ Time Frame: 36 months after the index procedure ]
    Safety Endpoints, defined as actionable, overt, and fatal bleeding by BARC definition


Eligibility Criteria
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Information from the National Library of Medicine

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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:

  • Subject must be at least 19 years of age.
  • Patients who do not occur a major adverse cardiac and cerebral events (MACCE) at 12-month after BRS implantation
  • Subject is able to verbally confirm understandings of risks, benefits and treatment alternatives of receiving P2Y12 antagonist monotherapy or aspirin plus P2Y12 antagonist and he/she or his/her legally authorized representative provides written informed consent prior to any study related procedure.

Exclusion Criteria:

  • Active bleeding
  • 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).
Contacts and Locations
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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): NCT03119012


Contacts
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Contact: Joo-Yong Hahn, MD, PhD 82-2-3410-6653 ichjy1@gmail.com
Contact: Joo Myung Lee, MD, MPH 82-2-3410-1246 drone80@hanmail.net

Locations
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Korea, Republic of
Samsung Medical Center Recruiting
Seoul, Korea, Republic of, 06351
Contact: Joo-Yong Hahn, MD, PhD    82-2-3410-6653    ichjy1@gmail.com   
Contact: Joo Myung Lee, MD, MPH    82-2-3410-1246    drone80@hanmail.net   
Sponsors and Collaborators
Samsung Medical Center
Investigators
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Study Chair: Joo-Yong Hahn, MD, PhD Samsung Medical Center
More Information
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Responsible Party: Joo-Yong Hahn, Professor, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT03119012    
Other Study ID Numbers: CHOICEII16453143
First Posted: April 18, 2017    Key Record Dates
Last Update Posted: April 9, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: After publication of first manuscript and trial results, the de-identified data will be shared by permission of principle investigator, when asked

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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:
Bioresorbable scaffold
Dual antiplatelet therapy
P2Y12 receptor inhibitor
Coronary artery disease
Additional relevant MeSH terms:
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Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Atherosclerosis
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Aspirin
Clopidogrel
Ticagrelor
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