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Optimized Antithrombotic Therapy of Acute Myocardial Infarction With Left Ventricular Mural Thrombus (OATH-AMI)

Primary Purpose

Acute Myocardial Infarction, Left Ventricular Thrombus

Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Combination of antiplatelet drugs and anticoagulants for at least one month
Sponsored by
The First Affiliated Hospital with Nanjing Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Myocardial Infarction

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • acute myocardial infarction with left ventricular mural thrombus

Exclusion Criteria:

  • BARC bleedings ≥ 2
  • atrial fibrillation
  • acute stroke or other systemic circulation embolism

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Experimental

    Experimental

    Experimental

    Experimental

    Arm Label

    aspirin100mg qd+clopidogrel75mg qd+warfarin (INR1.8-2.2)

    aspirin100mg qd+clopidogrel75mg qd+dabigatran110mg bid

    aspirin100mg qd+ticagrelor60mg bid+warfarin(INR1.8-2.2)

    aspirin100mg qd+ticagrelor60mg bid+dabigatran110mg bid

    Arm Description

    Outcomes

    Primary Outcome Measures

    Left ventricular mural thrombus-1
    Number of Participants Without left ventricular mural thrombus as Assessed by echocardiograph at 1-month.
    Left ventricular mural thrombus-3
    Number of Participants Without left ventricular mural thrombus as Assessed by echocardiograph at 3-month.
    Left ventricular mural thrombus-6
    Number of Participants Without left ventricular mural thrombus as Assessed by echocardiograph at 6-month.

    Secondary Outcome Measures

    Death
    Recurrent myocardial infarction
    Stroke or other systemic circulation embolism
    Stent restenosis
    Target vessel revascularization
    Major cardio-cerebral vascular events
    Composite of any events from outcome 2 to 6

    Full Information

    First Posted
    January 11, 2018
    Last Updated
    February 9, 2020
    Sponsor
    The First Affiliated Hospital with Nanjing Medical University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03415386
    Brief Title
    Optimized Antithrombotic Therapy of Acute Myocardial Infarction With Left Ventricular Mural Thrombus
    Acronym
    OATH-AMI
    Official Title
    A Multi-center Study on the Optimized Antithrombotic Therapy of Acute Myocardial Infarction With Left Ventricular Mural Thrombus.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    June 2020 (Anticipated)
    Primary Completion Date
    December 2020 (Anticipated)
    Study Completion Date
    June 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    The First Affiliated Hospital with Nanjing Medical University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    A multi-center study will be done to explore the optimal regimen of antithrombotic therapy for acute myocardial infarction with left ventricular mural thrombus. The investigators will evaluate the different combinations of antiplatelet drugs and anticoagulants for at least one month, such as aspirin 100mg qd+clopidogrel 75mg qd+warfarin (INR1.8-2.2), aspirin 100mg qd+clopidogrel 75mg qd+dabigatran 110mg bid, aspirin 100mg qd+ticagrelor 60mg bid+warfarin (INR1.8-2.2), and aspirin 100mg qd+ticagrelor 60mg bid+dabigatran 110mg bid. Transthoracic two-dimensional echocardiography will be done at the 1-month, 3-month and 6-month follow-ups to evaluate the left ventricular mural thrombus and determinate whether the antithrombotic therapy regimen could be regulated to double antiplatelet or anticoagulant+clopidogrel 75mg qd/ticagrelor 60mg bid. Then the investigators will complete the 12-month follow-up to evaluate the efficacy and safety of the optimal antithrombotic therapy regimen for acute myocardial infarction with left ventricular mural thrombus.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Acute Myocardial Infarction, Left Ventricular Thrombus

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Sequential Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    120 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    aspirin100mg qd+clopidogrel75mg qd+warfarin (INR1.8-2.2)
    Arm Type
    Experimental
    Arm Title
    aspirin100mg qd+clopidogrel75mg qd+dabigatran110mg bid
    Arm Type
    Experimental
    Arm Title
    aspirin100mg qd+ticagrelor60mg bid+warfarin(INR1.8-2.2)
    Arm Type
    Experimental
    Arm Title
    aspirin100mg qd+ticagrelor60mg bid+dabigatran110mg bid
    Arm Type
    Experimental
    Intervention Type
    Drug
    Intervention Name(s)
    Combination of antiplatelet drugs and anticoagulants for at least one month
    Intervention Description
    Combination of antiplatelet drugs and anticoagulants for at least one month, such as aspirin100mg qd+clopidogrel75mg qd+warfarin (INR1.8-2.2), aspirin100mg qd+clopidogrel75mg qd+dabigatran110mg bid, aspirin100mg qd+ticagrelor60mg bid+warfarin (INR1.8-2.2), and aspirin100mg qd+ticagrelor60mg bid+dabigatran110mg bid. Transthoracic two-dimensional echocardiography will be done at the 1-month, 3-month and 6-month follow-ups to evaluate the left ventricular mural thrombus and determinate whether the antithrombotic therapy regimen could be regulated to double antiplatelet or anticoagulant+clopidogrel75mg qd/ticagrelor60mg bid.
    Primary Outcome Measure Information:
    Title
    Left ventricular mural thrombus-1
    Description
    Number of Participants Without left ventricular mural thrombus as Assessed by echocardiograph at 1-month.
    Time Frame
    1-month
    Title
    Left ventricular mural thrombus-3
    Description
    Number of Participants Without left ventricular mural thrombus as Assessed by echocardiograph at 3-month.
    Time Frame
    3-month
    Title
    Left ventricular mural thrombus-6
    Description
    Number of Participants Without left ventricular mural thrombus as Assessed by echocardiograph at 6-month.
    Time Frame
    6-month
    Secondary Outcome Measure Information:
    Title
    Death
    Time Frame
    12 months
    Title
    Recurrent myocardial infarction
    Time Frame
    12 months
    Title
    Stroke or other systemic circulation embolism
    Time Frame
    12 months
    Title
    Stent restenosis
    Time Frame
    12 months
    Title
    Target vessel revascularization
    Time Frame
    12 months
    Title
    Major cardio-cerebral vascular events
    Description
    Composite of any events from outcome 2 to 6
    Time Frame
    12 months
    Other Pre-specified Outcome Measures:
    Title
    Major bleeding
    Description
    Bleeding Academic Research Consortium (BARC) bleedings ≥ 2
    Time Frame
    12 months
    Title
    Minor bleeding
    Description
    BARC bleedings < 2
    Time Frame
    12 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: acute myocardial infarction with left ventricular mural thrombus Exclusion Criteria: BARC bleedings ≥ 2 atrial fibrillation acute stroke or other systemic circulation embolism
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Liansheng Wang, Doctor
    Phone
    86 25 68303125
    Email
    drlswang@njmu.edu.cn
    First Name & Middle Initial & Last Name or Official Title & Degree
    Haoyu Meng, Doctor
    Phone
    86 25 68303126
    Email
    haoyu_meng@163.com

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    Citations:
    PubMed Identifier
    26320110
    Citation
    Roffi M, Patrono C, Collet JP, Mueller C, Valgimigli M, Andreotti F, Bax JJ, Borger MA, Brotons C, Chew DP, Gencer B, Hasenfuss G, Kjeldsen K, Lancellotti P, Landmesser U, Mehilli J, Mukherjee D, Storey RF, Windecker S; ESC Scientific Document Group. 2015 ESC Guidelines for the management of acute coronary syndromes in patients presenting without persistent ST-segment elevation: Task Force for the Management of Acute Coronary Syndromes in Patients Presenting without Persistent ST-Segment Elevation of the European Society of Cardiology (ESC). Eur Heart J. 2016 Jan 14;37(3):267-315. doi: 10.1093/eurheartj/ehv320. Epub 2015 Aug 29. No abstract available.
    Results Reference
    background
    PubMed Identifier
    28886621
    Citation
    Ibanez B, James S, Agewall S, Antunes MJ, Bucciarelli-Ducci C, Bueno H, Caforio ALP, Crea F, Goudevenos JA, Halvorsen S, Hindricks G, Kastrati A, Lenzen MJ, Prescott E, Roffi M, Valgimigli M, Varenhorst C, Vranckx P, Widimsky P; ESC Scientific Document Group. 2017 ESC Guidelines for the management of acute myocardial infarction in patients presenting with ST-segment elevation: The Task Force for the management of acute myocardial infarction in patients presenting with ST-segment elevation of the European Society of Cardiology (ESC). Eur Heart J. 2018 Jan 7;39(2):119-177. doi: 10.1093/eurheartj/ehx393. No abstract available.
    Results Reference
    background
    PubMed Identifier
    7464234
    Citation
    Reeder GS, Lengyel M, Tajik AJ, Seward JB, Smith HC, Danielson GK. Mural thrombus in left ventricular aneurysm: incidence, role of angiography, and relation between anticoagulation and embolization. Mayo Clin Proc. 1981 Feb;56(2):77-81.
    Results Reference
    background
    PubMed Identifier
    2643772
    Citation
    Turpie AG, Robinson JG, Doyle DJ, Mulji AS, Mishkel GJ, Sealey BJ, Cairns JA, Skingley L, Hirsh J, Gent M. Comparison of high-dose with low-dose subcutaneous heparin to prevent left ventricular mural thrombosis in patients with acute transmural anterior myocardial infarction. N Engl J Med. 1989 Feb 9;320(6):352-7. doi: 10.1056/NEJM198902093200604.
    Results Reference
    background
    PubMed Identifier
    8821415
    Citation
    Keeley EC, Hillis LD. Left ventricular mural thrombus after acute myocardial infarction. Clin Cardiol. 1996 Feb;19(2):83-6. doi: 10.1002/clc.4960190203.
    Results Reference
    background

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