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Clinical Trials/NCT03415386
NCT03415386
Unknown
Phase 4

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

Overview

Phase
Phase 4
Intervention
Combination of antiplatelet drugs and anticoagulants for at least one month
Conditions
Acute Myocardial Infarction
Sponsor
The First Affiliated Hospital with Nanjing Medical University
Enrollment
120
Primary Endpoint
Left ventricular mural thrombus-1
Last Updated
6 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 2020
End Date
June 2022
Last Updated
6 years ago
Study Type
Interventional
Study Design
Sequential
Sex
All

Investigators

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

Arms & Interventions

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

Intervention: Combination of antiplatelet drugs and anticoagulants for at least one month

aspirin100mg qd+clopidogrel75mg qd+dabigatran110mg bid

Intervention: Combination of antiplatelet drugs and anticoagulants for at least one month

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

Intervention: Combination of antiplatelet drugs and anticoagulants for at least one month

aspirin100mg qd+ticagrelor60mg bid+dabigatran110mg bid

Intervention: Combination of antiplatelet drugs and anticoagulants for at least one month

Outcomes

Primary Outcomes

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 Outcomes

  • Target vessel revascularization(12 months)
  • Major cardio-cerebral vascular events(12 months)
  • Recurrent myocardial infarction(12 months)
  • Stent restenosis(12 months)
  • Death(12 months)
  • Stroke or other systemic circulation embolism(12 months)

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