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Open label randomized controlled clinical trial to evaluate the efficacy and safety of apixaban versus warfarin in treating left ventricular thrombus in patients with acute or recent myocardial infarction (MI).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Apixaban | Experimental | Apixaban, 5 mg oral tablets, on top of updated guidelines of acute coronary syndrome management recommendations |
|
| Warfarin | Active Comparator | Warfarin, oral tablets, to achieve international normalized ratio (INR) of 2-3, on top of standards of care, as per updated guidelines of acute coronary syndrome management recommendations |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Apixaban | Drug | 5 mg twice daily, on top of standards of care. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Resolution of left ventricular thrombus | Transthoracic, noncontrast, echocardiographic assessment. | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Resolution of left ventricular thrombus | Transthoracic, noncontrast, echocardiographic assessment. | 6 months |
| Safety outcome | Major Adverse Cardiovascular Events (MACE) or any relevant bleeding according to the Bleeding Academic Research Consortium (BARC) classification |
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Inclusion Criteria:
All the following criteria must be fulfilled:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Saud AlBabtain Cardiac Center | Dammam | Saudi Arabia |
No plan to share.
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| ID | Term |
|---|---|
| C522181 | apixaban |
| D014859 | Warfarin |
| ID | Term |
|---|---|
| D015110 | 4-Hydroxycoumarins |
| D003374 | Coumarins |
| D001578 | Benzopyrans |
| D011714 | Pyrans |
| D006573 |
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Open label randomized controlled clinical trial, two parallel active groups, with blinded primary study outcome assessor.
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| Warfarin | Drug | Warfarin, oral tablets, to achieve international normalized ratio (INR) of 2-3, on top of standards of care, as per updated guidelines of acue coronary syndrome management recommendations |
|
| 3-6 months |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |