Left Ventricular Thrombus
Conditions
Brief summary
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).
Interventions
5 mg twice daily, on top of standards of care.
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
Sponsors
Study design
Intervention model description
Open label randomized controlled clinical trial, two parallel active groups, with blinded primary study outcome assessor.
Eligibility
Inclusion criteria
All the following criteria must be fulfilled: * Ages between 18 and 80 years, * History of anterior wall MI, either acute (within a week) or recent (within a month) * Evident left ventricular thrombus (LVT) by transthoracic echocardiography, * Naïve to oral anticoagulants (OAC) * stable to start OAC
Exclusion criteria
* Other indications for OAC, * Patients with contraindications for OAC, * Right ventricular thrombus or atrial thrombus, * History of confirmed stroke or other systemic embolization within the previous six months, * High bleeding risk, * Severe renal impairment, * Patients with expected difficulties to follow the INR strictly.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Resolution of left ventricular thrombus | 3 months | Transthoracic, noncontrast, echocardiographic assessment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Resolution of left ventricular thrombus | 6 months | Transthoracic, noncontrast, echocardiographic assessment. |
| Safety outcome | 3-6 months | Major Adverse Cardiovascular Events (MACE) or any relevant bleeding according to the Bleeding Academic Research Consortium (BARC) classification |
Countries
Saudi Arabia