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Trial record 2 of 509 for:    ASPIRIN AND P2

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

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.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Drug: Dual antiplatelet therapy with a P2Y12 inhibitor plus aspirin Phase 4

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 3500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Aspirin and a Potent P2Y12 Inhibitor Versus Aspirin and Clopidogrel Therapy in Patients Undergoing Elective Percutaneous Coronary Intervention for Complex Lesion Treatment (SMART-ATTEMPT)
Estimated Study Start Date : November 1, 2019
Estimated Primary Completion Date : June 30, 2023
Estimated Study Completion Date : December 31, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.

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

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.
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




Primary Outcome Measures :
  1. Major adverse cardiac events (MACE) [ Time Frame: 1-year after randomization ]
    A composite of death, myocardial infarction, or stent thrombosis


Secondary Outcome Measures :
  1. All-cause death [ Time Frame: 1-year after randomization ]
    Death by any cause

  2. Cardiac death [ Time Frame: 1-year after randomization ]
    Death by cardiac cause

  3. Myocardial infarction [ Time Frame: 1-year after randomization ]
    Myocardial infarction

  4. Stent thrombosis [ Time Frame: 1-year after randomization ]
    Definite or probable stent thrombosis

  5. Target lesion revascularization [ Time Frame: 1-year after randomization ]
    Repeat revascularization for target lesion of index PCI

  6. Target vessel revascularization [ Time Frame: 1-year after randomization ]
    Repeat revascularization for target vessel of index PCI

  7. Any revascularization [ Time Frame: 1-year after randomization ]
    Any repeat revascularization

  8. 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

  9. A composite of all-cause death/myocardial infarction [ Time Frame: 1-year after randomization ]
    A composite of all-cause death/myocardial infarction

  10. A composite of cardiac death/myocardial infarction [ Time Frame: 1-year after randomization ]
    A composite of cardiac death/myocardial infarction

  11. Cerebrovascular accident [ Time Frame: 1-year after randomization ]
    Cerebrovascular accident

  12. 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

  13. A composite of cardiac death/myocardial infarction/cerebrovascular accident [ Time Frame: 1-year after randomization ]
    A composite of cardiac death/myocardial infarction/cerebrovascular accident

  14. A composite of cardiac death/myocardial infarction/stent thrombosis [ Time Frame: 1-year after randomization ]
    A composite of cardiac death/myocardial infarction/stent thrombosis

  15. 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

  16. Bleeding by BARC types 2, 3, or 5 [ Time Frame: 1-year after randomization ]
    Bleeding defined by BARC types 2, 3 or 5

  17. Net adverse clinical events [ Time Frame: 1-year after randomization ]
    MACE + bleeding by BARC types 3 or 5



Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

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): NCT04014803


Contacts
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Contact: Joo-Yong Hahn, MD, PhD 82-2-3410-1246 ichjy1@gmail.com

Sponsors and Collaborators
Samsung Medical Center
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
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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: NCT04014803     History of Changes
Other Study ID Numbers: ATTEMPT16453143
First Posted: July 10, 2019    Key Record Dates
Last Update Posted: October 2, 2019
Last Verified: September 2019

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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
Dual Antiplatelet Therapy
Complex Coronary Lesion
Additional relevant MeSH terms:
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Aspirin
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Clopidogrel
Prasugrel Hydrochloride
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 Antagonists
Purinergic Agents