Using Apixaban to prevent blood clots after heart attacks
Apixaban Prophylaxis for Prevention of Left Ventricular Thrombus Following Anterior Myocardial Infarction: An Open Label, Randomized Clinical Trial (POTAMI)
This study is testing if a low dose of Apixaban can help prevent blood clots in people who have had a heart attack and have weak heart function.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 472 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | National Institute of Cardiovascular Diseases, Pakistan Academic / other |
| Locations | 1 site (Karachi, Sindh) |
| Trial ID | NCT06742567 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the safety and efficacy of low-dose Apixaban (2.5 mg twice daily) in preventing left ventricular thrombus formation in patients who have experienced an acute anterior myocardial infarction with severe left ventricular dysfunction. Participants will be randomly assigned to receive either Apixaban in addition to standard medical therapy or standard therapy alone. The study will follow patients for four weeks post-treatment to assess the incidence of thrombus formation. Eligible patients are those aged 18-65 with specific heart function criteria and without existing thrombus.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-65 who have suffered an acute anterior STEMI and have severe left ventricular dysfunction.
Not a fit: Patients with a history of previous myocardial infarction, advanced chronic kidney disease, or those requiring chronic anticoagulation may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly reduce the risk of thrombus formation in patients recovering from severe heart attacks.
How similar studies have performed: While the use of Apixaban in this specific context is novel, similar studies have shown promise in anticoagulation for thrombus prevention in other settings.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Karachi, Sindh
- NICVD Pakistan — Karachi, Sindh, Pakistan (Recruiting)
Study contacts
- Principal investigator: Abdul Hakeem Professor of Cardiology, Director Cardiac Catheterization Labs, MD FACC FSCAI FASE — Nicvd
- Study coordinator: Abdul Hakeem, MD FACC FSCAI FASE
- Email: ahakeem@gmail.com
- Phone: +92 3355554342
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.