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

Study Overview
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Brief Summary
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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.

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

Conditions
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Acute Myocardial Infarction, Left Ventricular Thrombus

Intervention / Treatment
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* Drug: Combination of antiplatelet drugs and anticoagulants for at least one month


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: acute myocardial infarction with left ventricular mural thrombus Exclusion Criteria: BARC bleedings ≥ 2 atrial fibrillation acute stroke or other systemic circulation embolism

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: aspirin100mg qd+clopidogrel75mg qd+warfarin (INR1.8-2.2)<br> | Drug: Combination of antiplatelet drugs and anticoagulants for at least one month<br>* 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.<br>|
| Experimental: aspirin100mg qd+clopidogrel75mg qd+dabigatran110mg bid<br> | Drug: Combination of antiplatelet drugs and anticoagulants for at least one month<br>* 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.<br>|
| Experimental: aspirin100mg qd+ticagrelor60mg bid+warfarin(INR1.8-2.2)<br> | Drug: Combination of antiplatelet drugs and anticoagulants for at least one month<br>* 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.<br>|
| Experimental: aspirin100mg qd+ticagrelor60mg bid+dabigatran110mg bid<br> | Drug: Combination of antiplatelet drugs and anticoagulants for at least one month<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Left ventricular mural thrombus-1 | Number of Participants Without left ventricular mural thrombus as Assessed by echocardiograph at 1-month. | 1-month | 
| Left ventricular mural thrombus-3 | Number of Participants Without left ventricular mural thrombus as Assessed by echocardiograph at 3-month. | 3-month | 
| Left ventricular mural thrombus-6 | Number of Participants Without left ventricular mural thrombus as Assessed by echocardiograph at 6-month. | 6-month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Death |  | 12 months | 
| Recurrent myocardial infarction |  | 12 months | 
| Stroke or other systemic circulation embolism |  | 12 months | 
| Stent restenosis |  | 12 months | 
| Target vessel revascularization |  | 12 months | 
| Major cardio-cerebral vascular events | Composite of any events from outcome 2 to 6 | 12 months |