Objective To compare the safety and efficacy of Apixaban vs. placebo in the prevention of
LV thrombus formation in patients with acute anterior myocardial and severe LV
dysfunction following primary PCI in an open label, randomized controlled trial.
Methods:
Inclusion Criteria .Patients aged 18-65 years, presenting with acute anterior STEMI and
severe LV dysfunction (EF<35%) with antero-apical akinesis, dyskinesis, or aneurysm.
Exclusion Criteria
Patients with previous myocardial infarction or revascularization procedures.
Patients with cardiogenic shock
Patients with advanced CKD (Cr < 2 and those on hemodialysis)
Recent ICH or major bleed requiring transfusion, low platelet counts<100,000
History of CVA
Patients with atrial fibrillation or other indications for chronic anticoagulation
Pregnant patients and those with hematological disorders
Eligible patients will be enrolled after informed consent. Randomization will be
undertaken once post PCI echocardiography is done and LV function is recorded. Patients
randomized to the treatment arm will be given Apixaban 2.5 mg twice daily and DAPT for
two weeks in addition to other guideline directed medical therapy (GDMT). After two weeks
of triple therapy (DOAC+DAPT), aspirin will be dropped in the study arm. The control arm
will be of standard care. After 4 weeks, treatment group will be switched to DAPT.
Follow up The primary endpoint will be the incidence of LV thrombus formation recorded at
4-week follow-up echocardiography. Patients' clinical status, side effects, and
medication compliance will be recorded.
At 2-week: patients will be contacted via phone call to assess their clinical status,
ensure drug compliance, discuss any necessary changes in drug regimen for those in the
treatment group already prescribed on discharge, and inquire about any side effects.
At 4-week: patients will undergo an in-person follow-up where echocardiography will be
conducted alongside a comprehensive assessment In case of any cardiac complaints,
patients will be advised to visit the hospital or cardiologist promptly to complete a
comprehensive clinical and laboratory workup. Primary endpoint
. Incidence of LV thrombus formation in the treatment arm vs. placebo at 4 week follow up
echocardiography.
Secondary endpoints
composite of death, recurrent myocardial infarction, stent thrombosis, and heart
failure hospitalization in experimental arm vs. control group.
Major and minor bleeding in experimental arm vs. control group
Discontinuation of the drug due to side effects in experimental arm vs. control
group A clinical events committee whose members are unaware of study-group
assignments will independently adjudicate all potential endpoints.
