RecruitingPhase 3NCT06742567

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

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

Sponsor

National Institute of Cardiovascular Diseases, Pakistan

Enrollment

472 participants

Start Date

Dec 2, 2024

Study Type

INTERVENTIONAL

Conditions

Acute Myocardial Infarction of Anterior Wall

Summary

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

Min Age: 18 YearsMax Age: 75 Years

Inclusion Criteria4

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 Criteria8

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

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Interventions

DRUGApixaban 2.5 MG PO BID

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.

DRUGControl (Standard treatment)

DAPT plus guideline directed medical therapy

Locations(1)

NICVD Pakistan

Karachi, Sindh, Pakistan

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NCT06742567