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

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorNational Institute of Cardiovascular Diseases, Pakistan

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Apixaban 2.5 MG PO BID

    Drug

    Patients 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)

    Drug

    DAPT plus guideline directed medical therapy

Treatment groups

472 Participants
are divided into 2 treatment groups
Group A: Study arm (Apixaban 2.5 mg bid)Experimental treatment 1 intervention
Group B: Control groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
one month

Secondary outcomes

1

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

Time frame
one month

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.