Anticoagulation in Post MI LV Thrombus Trial in Nepal

Launched by SHAHID GANGALAL NATIONAL HEART CENTRE · Mar 20, 2023

Keywords

ClinConnect Summary

This clinical trial, called the Anticoagulation in Post MI LV Thrombus Trial in Nepal, is studying the effectiveness and safety of a medication called Rivaroxaban compared to Warfarin for treating a condition known as left ventricular thrombus, which can occur after a heart attack. Left ventricular thrombus is a blood clot that forms in the heart's left ventricle after a heart attack, and it can lead to serious complications like strokes. The trial aims to see if Rivaroxaban, a newer type of blood thinner that doesn’t require as much monitoring, is just as good or better than Warfarin, which requires regular blood tests and dietary changes.

To be eligible for this trial, participants need to be over 18 years old, have been hospitalized with a recent heart attack, and have a confirmed left ventricular thrombus through a specialized heart scan called a cardiac MRI. Those who have certain medical conditions that might increase bleeding risk or are currently on anticoagulation therapy will not be included. If someone joins the trial, they will be randomly assigned to receive either Rivaroxaban or Warfarin for three months. Throughout the study, researchers will monitor participants to see how well the treatment works and if there are any serious side effects. This research is important because it could help improve treatment options for patients with this condition in Nepal.

Gender

ALL

Eligibility 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.