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.

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
SUMMARY

Introduction: The prevalence of left ventricular(LV) thrombus after acute myocardial infarction has decreased with thrombolysis and primary angioplasty intervention worldwide. However, most of the patients in our country present late after the onset of ischemia resulting in a comparable increase proportion of late presentation MI compared to developed countries. This delayed presentation is associated with the increased incidence of LV thrombus, associated with increased cerebrovascular and cardiovascular events resulting in increased morbidity and mortality. The Vitamin K Antagonist Warfarin is indicated in recent guidelines for the duration of 3-6 months. The use of Warfarin is less in our part of the world due to the requirement of frequent International Normalized Ration (INR) monitoring and dietary restrictions. Novel oral anticoagulants (NOACs) are an alternate option for such hindrance to the treatment of LV thrombus. This research will help assess the safety and efficacy of Rivaroxaban, one of the NOACs compared to warfarin.

Objectives: Our aim will be to compare the efficacy of rivaroxaban compared to warfarin in the complete resolution of post-MI LV thrombus. The primary efficacy endpoint of our study will be a resolution of LV thrombus as assessed by cardiac MRI at the end of 3 months of the study period. The secondary endpoint will be the comparison of the safety of both drugs measured by the incidence of major bleeding and embolic events.

Methods: The patients who present late after acute MI in our center with LV thrombus will be enrolled in our study. The diagnosis of LV thrombus will be diagnosed by cardiac MRI, which is considered the gold standard for the diagnosis. The patients then will be randomized in a 1:1 ratio to either warfarin or rivaroxaban within 24 hours of diagnosis of LV thrombus. The warfarin group will be prescribed the warfarin in the dose of 5mg daily and the dose titrated according to the INR value to maintain the INR range of 2 to 3. Rivaroxaban group will be prescribed 15 to 20mg according to the indication. The research group consisting of the principal investigator and coinvestigators will be responsible for the recruitment and overall study procedures.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Patients aged \>18 years hospitalized with the diagnosis of acute STEMI and

• Presence of LV thrombus which is confirmed with cardiac MRI.

Locations
Other Locations
Nepal
Nepal Health Research Council
RECRUITING
Kathmandu
Contact Information
Primary
Dipanker Prajapati, MBBS, MD
dpcardio@hotmail.com
9849273202
Time Frame
Start Date: 2023-06-19
Estimated Completion Date: 2026-04
Participants
Target number of participants: 196
Treatments
Experimental: Rivaroxaban
In this arm, the patients with post-myocardial infarction and left ventricular thrombus will be treated with Rivaroxaban 20mg or 15mg as indicated.
Active_comparator: Warfarin
In this arm, the patients with post-myocardial infarction and left ventricular thrombus will be treated with warfarin with a dose adjusted with the International Normalised ratio range of 2.0 to 3.0.
Related Therapeutic Areas
Sponsors
Leads: Shahid Gangalal National Heart Centre

This content was sourced from clinicaltrials.gov