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Aspirin and a PoTent P2Y12 Inhibitor Versus Aspirin and Clopidogrel in Patients Undergoing PCI for Complex Lesion (ATTEMPT)

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ClinicalTrials.gov Identifier: NCT04014803
Recruitment Status : Not yet recruiting
First Posted : July 10, 2019
Last Update Posted : October 2, 2019
Sponsor:
Collaborators:
Inje University
Seoul St. Mary's Hospital
Mediplex Sejong Hospital
Chonnam National University Hospital
Sejong General Hospital
Wonkwang University Hospital
Gachon University Gil Medical Center
Keimyung University Dongsan Medical Center
Chungbuk National University Hospital
Yeungnam University Hospital
Chungnam National University Hospital
Wonju Severance Christian Hospital
Konkuk University Chungju Hospital
Chung-Ang University Hosptial, Chung-Ang University College of Medicine
Dankook University
Incheon St.Mary's Hospital
Gyeongsang National University Hospital
Soonchunhyang University Hospital
Ewha Womans University Seoul hospital
Information provided by (Responsible Party):
Joo-Yong Hahn, Samsung Medical Center

Tracking Information
First Submitted Date  ICMJE July 8, 2019
First Posted Date  ICMJE July 10, 2019
Last Update Posted Date October 2, 2019
Estimated Study Start Date  ICMJE November 1, 2019
Estimated Primary Completion Date June 30, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 8, 2019)
Major adverse cardiac events (MACE) [ Time Frame: 1-year after randomization ]
A composite of death, myocardial infarction, or stent thrombosis
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 8, 2019)
  • All-cause death [ Time Frame: 1-year after randomization ]
    Death by any cause
  • Cardiac death [ Time Frame: 1-year after randomization ]
    Death by cardiac cause
  • Myocardial infarction [ Time Frame: 1-year after randomization ]
    Myocardial infarction
  • Stent thrombosis [ Time Frame: 1-year after randomization ]
    Definite or probable stent thrombosis
  • Target lesion revascularization [ Time Frame: 1-year after randomization ]
    Repeat revascularization for target lesion of index PCI
  • Target vessel revascularization [ Time Frame: 1-year after randomization ]
    Repeat revascularization for target vessel of index PCI
  • Any revascularization [ Time Frame: 1-year after randomization ]
    Any repeat revascularization
  • A composite of all-cause death/myocardial infarction/stent thrombosis/any revascularization [ Time Frame: 1-year after randomization ]
    A composite of all-cause death/myocardial infarction/stent thrombosis/any revascularization
  • A composite of all-cause death/myocardial infarction [ Time Frame: 1-year after randomization ]
    A composite of all-cause death/myocardial infarction
  • A composite of cardiac death/myocardial infarction [ Time Frame: 1-year after randomization ]
    A composite of cardiac death/myocardial infarction
  • Cerebrovascular accident [ Time Frame: 1-year after randomization ]
    Cerebrovascular accident
  • A composite of all-cause death/myocardial infarction/cerebrovascular accident [ Time Frame: 1-year after randomization ]
    A composite of all-cause death/myocardial infarction/cerebrovascular accident
  • A composite of cardiac death/myocardial infarction/cerebrovascular accident [ Time Frame: 1-year after randomization ]
    A composite of cardiac death/myocardial infarction/cerebrovascular accident
  • A composite of cardiac death/myocardial infarction/stent thrombosis [ Time Frame: 1-year after randomization ]
    A composite of cardiac death/myocardial infarction/stent thrombosis
  • Bleeding by BARC types 3 or 5 [ Time Frame: 1-year after randomization ]
    Bleeding defined by Bleeding Academic Research Consortium (BARC) types 3 or 5
  • Bleeding by BARC types 2, 3, or 5 [ Time Frame: 1-year after randomization ]
    Bleeding defined by BARC types 2, 3 or 5
  • Net adverse clinical events [ Time Frame: 1-year after randomization ]
    MACE + bleeding by BARC types 3 or 5
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Aspirin and a PoTent P2Y12 Inhibitor Versus Aspirin and Clopidogrel in Patients Undergoing PCI for Complex Lesion
Official Title  ICMJE Aspirin and a Potent P2Y12 Inhibitor Versus Aspirin and Clopidogrel Therapy in Patients Undergoing Elective Percutaneous Coronary Intervention for Complex Lesion Treatment (SMART-ATTEMPT)
Brief Summary This study is a prospective, open label, two-arm, randomized multicenter trial to evaluate the efficacy and safety of aspirin plus prasugrel as compared with aspirin plus clopidogrel in patients undergoing elective percutaneous coronary intervention with drug eluting stents for complex coronary lesions.
Detailed Description

Over the past several decades, dual antiplatelet therapy (DAPT) with the combination of aspirin and a P2Y12 inhibitor has become an essential treatment in patients undergoing percutaneous coronary intervention (PCI) to reduce ischemic events. Although the optimal duration of DAPT still remains controversial in patients with coronary artery disease, the recommended duration of maintenance of DAPT for patients undergoing PCI with drug-eluting stent is ≥12 months for those with acute coronary syndrome (ACS), and ≥6 months for those with stable coronary artery disease according to the current guidelines. However, individualized approach based on ischemic versus bleeding risks assessment is needed to determine the optimal duration of DAPT in various population.

Several studies reported that patients undergoing PCI for complex lesions had significantly higher rates of ischemic events than those with non-complex lesions. Moreover, prolonged DAPT of aspirin and clopidogrel more than 1 year significantly reduced the risk of cardiac ischemic events up to 44% in patients undergoing PCI for complex coronary lesions, and the current guideline recommends prolonged DAPT duration may be considered in patients undergoing complex PCI. Apart from prolonged use of DAPT, use of more potent P2Y12 inhibitor than clopidogrel may be another strategy to reduce ischemic events in patients undergoing PCI for complex coronary lesions. Prasugrel, a new thienopyridine, inhibits platelet aggregation more rapidly and potently than clopidogrel. In the TRITON-TIMI 38 (TRial to Assess Improvement in Therapeutic Outcomes by Optimizing Platelet InhibitioN with Prasugrel) study, prasugrel reduced ischemic events compared with clopidogrel in patients with acute coronary syndrome. Moreover, low dose prasugrel also reduced ischemic events without an excessive bleeding risk in Japanese population. Therefore, DAPT of aspirin and prasugrel would reduce recurrent ischemic events than DAPT of aspirin and clopidogrel in patients undergoing PCI for complex lesions, a high risk group of ischemic events, even when they do not present with myocardial infarction. So far, there have been no data on this issue.

The aim of the SMART-ATTEMPT (Aspirin and a PoTent P2Y12 inhibitor versus aspirin and clopidogrel Therapy in patients undergoing Elective percutaneous coronary intervention for coMPlex lesion Treatment) trial is to evaluate the efficacy and safety of aspirin plus prasugrel as compared with aspirin plus clopidogrel in patients undergoing elective PCI for complex lesions.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Coronary Artery Disease
Intervention  ICMJE Drug: Dual antiplatelet therapy with a P2Y12 inhibitor plus aspirin

Dual antiplatelet therapy with a P2Y12 inhibitor plus aspirin will be given according to the allocated arms in patients undergoing elective percutaneous coronary intervention for complex coronary lesion

  1. Prasugrel plus Aspirin arm
  2. Clopidogrel plus Aspirin arm
Other Name: Prasugrel plus Aspirin or Clopidogrel plus Aspirin
Study Arms  ICMJE
  • Active Comparator: Prasugrel plus Aspirin arm

    Patients will receive 300 mg of aspirin before PCI unless they have previously received this antiplatelet medication. A loading dose of prasugrel 60 mg will be given before or after PCI as soon as possible following randomization, unless they have previously received the assigned medication. Aspirin 100 mg plus prasugrel 10 mg once daily* will be given for one year.

    * Based on previous studies including PRASFIT-ACS (PRASugrel compared with clopidogrel For Japanese patIenTs with ACS undergoing PCI) or TRILOGY ACS (The Targeted Platelet Inhibition to Clarify the Optimal Strategy to Medically Manage Acute Coronary Syndromes), maintenance dose can be reduced to 5 mg once daily in patients with high bleeding risk or by investigator's medical judgement.

    Intervention: Drug: Dual antiplatelet therapy with a P2Y12 inhibitor plus aspirin
  • Active Comparator: Clopidogrel plus Aspirin arm
    Patients will receive 300 mg of aspirin before PCI unless they have previously received this antiplatelet medication. A loading dose of clopidogrel 600 mg will be given before or after PCI as soon as possible following randomization, unless they have previously received the assigned medication. Aspirin 100 mg plus clopidogrel 75 mg once daily will be given for one year.
    Intervention: Drug: Dual antiplatelet therapy with a P2Y12 inhibitor plus aspirin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: July 8, 2019)
3500
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2023
Estimated Primary Completion Date June 30, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • ① Subject must be at least 19 years of age
  • ② Subject who can verbally confirm understandings of risks, benefits and treatment alternatives and he/she or his/her legally authorized representative provides written informed consent prior to any study related procedure
  • ③ Patients undergoing elective PCI as follows:

    1. True bifurcation lesion (Medina 1,1,1/1,0,1/0,1,1) with side branch ≥2.5 mm size
    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 (expected 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:

  • ① Hemodynamic instability or cardiogenic shock
  • ② Subjects with serious bleeding (Intracerebral hemorrhage, gastrointestinal bleeding, hematuria, hemoptysis, and etc.)
  • ③ Previous history of intracerebral hemorrhage, transient ischemic attack, or stroke
  • ④ Known hypersensitivity or contraindications to study medications (aspirin, clopidogrel, and prasugrel)
  • ⑤ Female of childbearing potential, unless a recent pregnancy test is negative, who possibly plan to become pregnant any time after enrollment into this study
  • ⑥ Non-cardiac co-morbid conditions are present with life expectancy <1 year or that may result in protocol non-compliance (per site investigator's medical judgment)
  • ⑦ Patients presenting with biomarker positive acute coronary syndrome
  • ⑧ Patients chronically taking prasugrel or ticagrelor (≥1 week)
  • ⑨ Subjects ≥75 years of age or <60 kg of body weight
  • ⑩ Patients taking warfarin or novel oral anticoagulants (dabigatran, rivaroxaban, edoxaban, or apixaban)

    • Eligible patients will be randomly assigned to treatment arms, stratified by participating centers, presence of diabetes mellitus, and stent types.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 19 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Joo-Yong Hahn, MD, PhD 82-2-3410-1246 ichjy1@gmail.com
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04014803
Other Study ID Numbers  ICMJE ATTEMPT16453143
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Joo-Yong Hahn, Samsung Medical Center
Study Sponsor  ICMJE Samsung Medical Center
Collaborators  ICMJE
  • Inje University
  • Seoul St. Mary's Hospital
  • Mediplex Sejong Hospital
  • Chonnam National University Hospital
  • Sejong General Hospital
  • Wonkwang University Hospital
  • Gachon University Gil Medical Center
  • Keimyung University Dongsan Medical Center
  • Chungbuk National University Hospital
  • Yeungnam University Hospital
  • Chungnam National University Hospital
  • Wonju Severance Christian Hospital
  • Konkuk University Chungju Hospital
  • Chung-Ang University Hosptial, Chung-Ang University College of Medicine
  • Dankook University
  • Incheon St.Mary's Hospital
  • Gyeongsang National University Hospital
  • Soonchunhyang University Hospital
  • Ewha Womans University Seoul hospital
Investigators  ICMJE
Study Chair: Joo-Yong Hahn, MD, PhD Samsung Medical Center
PRS Account Samsung Medical Center
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP