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

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ClinicalTrials.gov Identifier: NCT03415386
Recruitment Status : Not yet recruiting
First Posted : January 30, 2018
Last Update Posted : August 7, 2018
Sponsor:
Information provided by (Responsible Party):
The First Affiliated Hospital with Nanjing Medical University

Tracking Information
First Submitted Date  ICMJE January 11, 2018
First Posted Date  ICMJE January 30, 2018
Last Update Posted Date August 7, 2018
Estimated Study Start Date  ICMJE September 2018
Estimated Primary Completion Date September 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 5, 2018)
  • Left ventricular mural thrombus-1 [ Time Frame: 1-month ]
    Number of Participants Without left ventricular mural thrombus as Assessed by echocardiograph at 1-month.
  • Left ventricular mural thrombus-3 [ Time Frame: 3-month ]
    Number of Participants Without left ventricular mural thrombus as Assessed by echocardiograph at 3-month.
  • Left ventricular mural thrombus-6 [ Time Frame: 6-month ]
    Number of Participants Without left ventricular mural thrombus as Assessed by echocardiograph at 6-month.
Original Primary Outcome Measures  ICMJE
 (submitted: January 28, 2018)
  • Left ventricular mural thrombus [ Time Frame: 1-month ]
    Whether the left ventricular mural thrombus dissolves
  • Left ventricular mural thrombus-remain or recurrent [ Time Frame: 3-month ]
    Whether the mural thrombus remain or recurrent in left ventricular
  • Left ventricular mural thrombus-still remain or recurrent [ Time Frame: 6-month ]
    Whether the mural thrombus still remain or recurrent in left ventricular
Change History Complete list of historical versions of study NCT03415386 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 28, 2018)
  • Death [ Time Frame: 12 months ]
  • Recurrent myocardial infarction [ Time Frame: 12 months ]
  • Stroke or other systemic circulation embolism [ Time Frame: 12 months ]
  • Stent restenosis [ Time Frame: 12 months ]
  • Target vessel revascularization [ Time Frame: 12 months ]
  • Major cardio-cerebral vascular events [ Time Frame: 12 months ]
    Composite of any events from outcome 2 to 6
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: January 28, 2018)
  • Major bleeding [ Time Frame: 12 months ]
    Bleeding Academic Research Consortium (BARC) bleedings ≥ 2
  • Minor bleeding [ Time Frame: 12 months ]
    BARC bleedings < 2
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Optimized Antithrombotic Therapy of Acute Myocardial Infarction With Left Ventricular Mural Thrombus
Official Title  ICMJE A Multi-center Study on the Optimized Antithrombotic Therapy of Acute Myocardial Infarction With Left Ventricular Mural Thrombus.
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Acute Myocardial Infarction
  • Left Ventricular Thrombus
Intervention  ICMJE Drug: Combination of antiplatelet drugs and anticoagulants for at least one month
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.
Study Arms  ICMJE
  • Experimental: aspirin100mg qd+clopidogrel75mg qd+warfarin (INR1.8-2.2)
    Intervention: Drug: Combination of antiplatelet drugs and anticoagulants for at least one month
  • Experimental: aspirin100mg qd+clopidogrel75mg qd+dabigatran110mg bid
    Intervention: Drug: Combination of antiplatelet drugs and anticoagulants for at least one month
  • Experimental: aspirin100mg qd+ticagrelor60mg bid+warfarin(INR1.8-2.2)
    Intervention: Drug: Combination of antiplatelet drugs and anticoagulants for at least one month
  • Experimental: aspirin100mg qd+ticagrelor60mg bid+dabigatran110mg bid
    Intervention: Drug: Combination of antiplatelet drugs and anticoagulants for at least one month
Publications *

*   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: January 28, 2018)
120
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2020
Estimated Primary Completion Date September 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • acute myocardial infarction with left ventricular mural thrombus

Exclusion Criteria:

  • BARC bleedings ≥ 2
  • atrial fibrillation
  • acute stroke or other systemic circulation embolism
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Liansheng Wang, Doctor 86 25 68303125 drlswang@njmu.edu.cn
Contact: Haoyu Meng, Doctor 86 25 68303126 haoyu_meng@163.com
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03415386
Other Study ID Numbers  ICMJE OATH-AMI
Has Data Monitoring Committee Not Provided
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
Plan to Share IPD: Undecided
Responsible Party The First Affiliated Hospital with Nanjing Medical University
Study Sponsor  ICMJE The First Affiliated Hospital with Nanjing Medical University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account The First Affiliated Hospital with Nanjing Medical University
Verification Date January 2018

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