Acute Myocardial Infarction, Left Ventricular Thrombus
Conditions
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.
Interventions
DRUGCombination 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.
Sponsors
The First Affiliated Hospital with Nanjing Medical University
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* acute myocardial infarction with left ventricular mural thrombus
Exclusion criteria
* BARC bleedings ≥ 2 * atrial fibrillation * acute stroke or other systemic circulation embolism
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Left ventricular mural thrombus-6 | 6-month | Number of Participants Without left ventricular mural thrombus as Assessed by echocardiograph at 6-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-1 | 1-month | Number of Participants Without left ventricular mural thrombus as Assessed by echocardiograph at 1-month. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Stroke or other systemic circulation embolism | 12 months | — |
| Target vessel revascularization | 12 months | — |
| Major cardio-cerebral vascular events | 12 months | Composite of any events from outcome 2 to 6 |
| Stent restenosis | 12 months | — |
| Death | 12 months | — |
| Recurrent myocardial infarction | 12 months | — |
Other
| Measure | Time frame | Description |
|---|---|---|
| Minor bleeding | 12 months | BARC bleedings \< 2 |
| Major bleeding | 12 months | Bleeding Academic Research Consortium (BARC) bleedings ≥ 2 |
Contacts
Primary ContactLiansheng Wang, Doctor
Backup ContactHaoyu Meng, Doctor
Outcome results
None listed