Status:
RECRUITING
Apixaban Prophylaxis for Prevention of Left Ventricular Thrombus Following Anterior Myocardial Infarction
Lead Sponsor:
National Institute of Cardiovascular Diseases, Pakistan
Conditions:
Acute Myocardial Infarction of Anterior Wall
Left Ventricular Thrombus
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief 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 medica...
Detailed 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 P...
Eligibility Criteria
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
Key Trial Info
Start Date :
December 2 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 30 2025
Estimated Enrollment :
472 Patients enrolled
Trial Details
Trial ID
NCT06742567
Start Date
December 2 2024
End Date
November 30 2025
Last Update
December 19 2024
Active Locations (1)
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1
NICVD Pakistan
Karachi, Sindh, Pakistan