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

Phase 4

• Conditions: Acute Myocardial Infarction; Left Ventricular Thrombus
• Interventions: Drug: Combination of antiplatelet drugs and anticoagulants for at least one month

• Registration Number: NCT03415386
• Lead Sponsor: The First Affiliated Hospital with Nanjing Medical University

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 available

Study Timeline

• Study First Submitted: 2018-01-11
• Study First Submitted QC: 2018-01-28
• Study First Posted: 2018-01-30
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-09
• Last Update Posted: 2020-02-11
• Study Start: 2020-06
• Primary Completion: 2020-12
• Study Completion: 2022-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• acute myocardial infarction with left ventricular mural thrombus

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
aspirin100mg qd+clopidogrel75mg qd+warfarin (INR1.8-2.2)	Combination of antiplatelet drugs and anticoagulants for at least one month	-
aspirin100mg qd+clopidogrel75mg qd+dabigatran110mg bid	Combination of antiplatelet drugs and anticoagulants for at least one month	-
aspirin100mg qd+ticagrelor60mg bid+warfarin(INR1.8-2.2)	Combination of antiplatelet drugs and anticoagulants for at least one month	-
aspirin100mg qd+ticagrelor60mg bid+dabigatran110mg bid	Combination of antiplatelet drugs and anticoagulants for at least one month	-

Primary Outcome Measures

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

Secondary Outcome Measures

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