About this trial
The objective of this randomized controlled trial is to compare the safety and efficacy of low dose Apixaban (2.5 mg bid) in addition to guideline directed medical therapy vs guideline directed medical therapy alone in the prevention of left ventricular thrombus formation (after 30-days) following primary PCI in patients with acute anterior myocardial infarction with severe LV dysfunction.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients aged 18-65 years
Presenting with acute anterior STEMI
Severe LV dysfunction (EF<35%) with antero-apical akinesis, dyskinesis, or aneurysm
WIHTOUT evidence of LV thrombus.
Disqualifiers
Patients with previous anterior myocardial infarction or LAD revascularization procedures
Patients with cardiogenic shock
Patients with LV thrombus
Patients with advanced CKD (Cr > 2 and those on hemodialysis)
Trial design
Parallel
Treatments tested in this trial
Apixaban 2.5 MG PO BID
DrugPatients randomized to the treatment arm will be given Apixaban 2.5 mg twice daily and DAPT (aspirin (75 mg) + clopidogrel (75 mg)) for four weeks in addition to other guideline directed medical therapy (GDMT). After 4 weeks, treatment group will be switched to DAPT.
Control (Standard treatment)
DrugDAPT plus guideline directed medical therapy
Treatment groups
Trial outcomes
Primary outcomes
Incidence of LV thrombus formation in the treatment arm vs. control group
Incidence of LV thrombus formation in the treatment arm vs. control group at 4 week follow up echocardiography. This constitutes the primary endpoint of the trial
Secondary outcomes
Secondary Outcomes
* composite of death, recurrent myocardial infarction, stent thrombosis, and heart failure hospitalization in the treatment arm vs. control group * Major and minor bleeding in the treatment arm vs. control group 3) Discontinuation of the drug due to side effects
Sponsors and contacts
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