Comparing anticoagulants for treating left ventricular thrombus after heart attacks in Nepal

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Nepal Health Research Council
  Kathmandu, Bagmati, Nepal Recruiting

Study contacts

• Study coordinator: Dipanker Prajapati, MBBS, MD
• Email: dpcardio@hotmail.com
• Phone: 9849273202

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.