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

National Institute of Cardiovascular Diseases, Pakistan

Status and phase: Enrolling; Phase 3

Conditions: Acute Myocardial Infarction of Anterior Wall; Prophylaxis; Left Ventricular Thrombus

Treatments: Drug: Apixaban 2.5 MG PO BID; Drug: Control (Standard treatment)

Study type: Interventional

Funder types: Other

Identifiers

NCT06742567

IRB-83/2024

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 472 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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)
• Recent ICH or major bleed requiring transfusion, low platelet counts <100,000
• History of recent CVA ( within past three months)
• Patients with atrial fibrillation or other indications for chronic anticoagulation
• Pregnant patients and those with hematological disorders

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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472 participants in 2 patient groups

Study arm (Apixaban 2.5 mg bid)

Experimental group

Description:

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. o In the event of stent thrombosis during the study period, considering the high ischemic risk, the patient will be switched to ticagrelor instead of clopidogrel, and aspirin will be discontinued while Apixaban will be continued. After four weeks, the patient will be switched to DAPT (aspirin + ticagrelor).

Treatment:

Drug: Apixaban 2.5 MG PO BID

Control group

Active Comparator group

Description:

The control arm will be of standard care i.e. DAPT in addition to other guideline directed medical therapy (GDMT).

Treatment:

Drug: Control (Standard treatment)