Apixaban Prophylaxis for Prevention of Left Ventricular Thrombus Following Anterior Myocardial Infarction: An Open Label, Randomized Clinical Trial (POTAMI)
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:
• 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.
Locations
Other Locations
Pakistan
NICVD Pakistan
RECRUITING
Karachi
Contact Information
Primary
Abdul Hakeem, MD FACC FSCAI FASE
ahakeem@gmail.com
+92 3355554342
Backup
Sabha Bhatti, MD FASE FASNC FACC
drsabhabhatti@gmail.com
608-772-3048
Time Frame
Start Date: 2024-12-02
Estimated Completion Date: 2025-11-30
Participants
Target number of participants: 472
Treatments
Experimental: Study arm (Apixaban 2.5 mg 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. 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).
Active_comparator: Control group
The control arm will be of standard care i.e. DAPT in addition to other guideline directed medical therapy (GDMT).
Related Therapeutic Areas
Sponsors
Leads: National Institute of Cardiovascular Diseases, Pakistan