Apixaban Prophylaxis for Prevention of Left Ventricular Thrombus Following Anterior Myocardial Infarction: An Open Label, Randomized Clinical Trial (POTAMI)

What this Trial Is About

Researchers are evaluating the safety and effectiveness of low-dose Apixaban combined with standard medical therapy compared to standard therapy alone to prevent left ventricular (LV) thrombus formation after primary PCI in patients with acute anterior myocardial infarction and severe LV dysfunction. This open-label, randomized controlled trial focuses on patients aged 18 to 65 years with an ejection fraction below 35% and specific heart motion abnormalities. Participants will be randomly assigned to receive either Apixaban 2.5 mg twice daily plus dual antiplatelet therapy (aspirin and clopidogrel) for four weeks along with guideline-directed medical therapy, or guideline-directed medical therapy alone including dual antiplatelet therapy. After four weeks, those in the Apixaban group will continue with dual antiplatelet therapy. In case of stent thrombosis, some medication adjustments may be made. Follow-up includes phone assessments at two weeks and an in-person visit with echocardiography at four weeks. During the study, participants will be monitored for LV thrombus formation using echocardiography at four weeks, and clinical status, medication side effects, and adherence will be assessed. The primary outcome is the incidence of LV thrombus formation at one month. Secondary measures include rates of death, recurrent heart attacks, stent thrombosis, heart failure hospitalizations, bleeding events, and drug discontinuation due to side effects. Safety and outcomes will be independently reviewed by a clinical events committee.

Apixaban Prophylaxis for Prevention of Left Ventricular Thrombus Following Anterior Myocardial Infarction