Optimized Antithrombotic Therapy of Acute Myocardial Infarction With Left Ventricular Mural Thrombus

Overview

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.

Full Title of Study: “A Multi-center Study on the Optimized Antithrombotic Therapy of Acute Myocardial Infarction With Left Ventricular Mural Thrombus.”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Sequential Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Outcomes Assessor)
  • Study Primary Completion Date: December 2020

Interventions

  • 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.

Arms, Groups and Cohorts

  • Experimental: aspirin100mg qd+clopidogrel75mg qd+warfarin (INR1.8-2.2)
  • Experimental: aspirin100mg qd+clopidogrel75mg qd+dabigatran110mg bid
  • Experimental: aspirin100mg qd+ticagrelor60mg bid+warfarin(INR1.8-2.2)
  • Experimental: aspirin100mg qd+ticagrelor60mg bid+dabigatran110mg bid

Clinical Trial Outcome Measures

Primary Measures

  • 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.

Secondary Measures

  • 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

Participating in This Clinical Trial

Inclusion Criteria

  • acute myocardial infarction with left ventricular mural thrombus Exclusion Criteria:

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

Gender Eligibility: All

Minimum Age: 20 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • The First Affiliated Hospital with Nanjing Medical University
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Contact(s)
    • Liansheng Wang, Doctor, 86 25 68303125, drlswang@njmu.edu.cn

References

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.

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, Widimský 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.

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.

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.

Keeley EC, Hillis LD. Left ventricular mural thrombus after acute myocardial infarction. Clin Cardiol. 1996 Feb;19(2):83-6. Review.

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