Comparing anticoagulants for treating left ventricular thrombus after heart attacks in Nepal
Comparison of Warfarin Versus Rivaroxaban in Management of Post-myocardial Infarction Left Ventricular Thrombus in a Tertiary Cardiac Center of Nepal: a Randomized Control Study.
This study is testing whether two blood-thinning medications, Rivaroxaban and Warfarin, can help people in Nepal with blood clots in the heart after a heart attack.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 196 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Shahid Gangalal National Heart Centre Academic / other |
| Locations | 1 site (Kathmandu, Bagmati) |
| Trial ID | NCT05794399 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the safety and efficacy of two anticoagulants, Rivaroxaban and Warfarin, in patients diagnosed with left ventricular thrombus following an acute ST-Elevation Myocardial Infarction (STEMI) in Nepal. The study aims to address the challenges faced by patients who present late for treatment, which increases the risk of thrombus formation and subsequent complications. Participants will be monitored for outcomes related to thrombus resolution and any adverse events associated with the anticoagulant therapies. The trial will utilize cardiac MRI to confirm the presence of LV thrombus before randomization.
Who should consider this trial
Good fit: Ideal candidates for this study are adults over 18 years old who have been hospitalized with acute STEMI and confirmed left ventricular thrombus.
Not a fit: Patients with active bleeding risks, severe comorbidities, or those currently undergoing anticoagulation therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more effective and accessible treatment option for patients with left ventricular thrombus, potentially reducing morbidity and mortality associated with myocardial infarction.
How similar studies have performed: Other studies have shown promising results with the use of novel oral anticoagulants in similar patient populations, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients aged \>18 years hospitalized with the diagnosis of acute STEMI and * Presence of LV thrombus which is confirmed with cardiac MRI. Exclusion Criteria: 1. Bleeding risk Active bleeding; history of intracranial hemorrhage; clinically significant gastrointestinal bleeding within 12 months before randomization; severe thrombocytopenia (\<50×109/L), or anemia (i.e., hemoglobin \<90 g/L) at screening or pre-randomization; Liver function Child-Pugh B or C; untreated arterial aneurysm, arterial or venous malformation and aorta dissection; and body weight \<40 kg. 2. Undergoing anticoagulation therapy 3. Cardiovascular condition Cardiac shock; uncontrolled blood pressure (SBP ≥180 mmHg); planned CABG within 3 months; suspicious Pseudo-ventricular aneurysm 4. Concomitant diseases Severe chronic or acute renal failure (CrCl \<50 mL/min at screening or pre-randomization); significant liver disease; current substance abuse (drug or alcohol) problem; life expectancy to less than 12 months; Known allergies, or intolerance to rivaroxaban; Woman who is currently pregnant, or breastfeeding; and Other hypercoagulable states, such as a malignant tumor, SLE 5. Other conditions adjudicated by investigators to be unsuitable for anticoagulation 6. Pregnant women and participants with any cognitive impairment.
Where this trial is running
Kathmandu, Bagmati
- Nepal Health Research Council — Kathmandu, Bagmati, Nepal (Recruiting)
Study contacts
- Study coordinator: Dipanker Prajapati, MBBS, MD
- Email: dpcardio@hotmail.com
- Phone: 9849273202
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.