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

Nanjing Medical University

Status and phase: Unknown; Phase 4

Conditions: Left Ventricular Thrombus; Acute Myocardial Infarction

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

Study type: Interventional

Funder types: Other

Identifiers

NCT03415386

OATH-AMI

Details and patient eligibility

About

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.

Enrollment: 120 estimated patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• acute myocardial infarction with left ventricular mural thrombus

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Single Blind

---

120 participants in 4 patient groups

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

Experimental group

Treatment:

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

aspirin100mg qd+clopidogrel75mg qd+dabigatran110mg bid

Experimental group

Treatment:

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

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

Experimental group

Treatment:

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

aspirin100mg qd+ticagrelor60mg bid+dabigatran110mg bid

Experimental group

Treatment:

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