NCT04970576

Rivaroxaban in Left Ventricular Thrombus

Efficacy of Rivaroxaban in Patients With Left Ventricular Thrombus After Acute Myocardial Infarction: An Open Label Randomized Control Trial

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 261 (actual)
• Sponsor: National Institute of Cardiovascular Diseases, Pakistan · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The left ventricular (LV) thrombus is an important complication of myocardial infarction (MI) and vitamin K antagonist (VKA) is the current recommended management therapy for these patients. However, lack of regular international normalized ratio (INR) monitoring, drug, and food interaction may leads to increased risk of over or under anticoagulation consequently compromising the effectiveness of the therapy. Hence, due to benefits like predictable dosing and lack of need for regular monitoring, use of non-vitamin K antagonist oral anticoagulants (NOACs) for these patients is increasing among cardiologists. However, clinical data for the justified use of NOACs in LV thrombus (LVT) are lacking and remained a point of debate among the cardiologists. A recently published Randomized Control Trial (RCT) by Abdelnabi M et al. namely the No-LVT trial, had established the safety of Rivaroxaban therapy in patient with post myocardial infarction (MI) LV thrombus along with promising efficacy. However, sample size of the study (n=79; 39 in Rivaroxaban and 40 Warfarin) was not sufficiently high enough to conclude efficacy of Rivaroxaban in these patients. Therefore, this open label RCT is designed with the primary objective to evaluate the efficacy of Rivaroxaban in resolution of post MI LV thrombus as compared to standard warfarin therapy at the interval of 1 month and 3 months to test the hypothesis that Rivaroxaban is safe and non-inferior in preventing thromboembolic and major bleeding events in these patients.

Conditions

• Acute Coronary Syndrome
• Left Ventricular Thrombus

Interventions

Type	Name	Description
DRUG	Rivaroxaban	Dose of 20 mg once a day for three months followed by transthoracic echocardiographic assessment for presence/absence of LV thrombus after 4 weeks and 12 weeks
DRUG	Warfarin	Dose as per the target INR of 2 to 3 with transthoracic echocardiographic assessment for presence/absence of LV thrombus after 4 weeks and 12 weeks

Timeline

• Start date: 2021-06-25
• Primary completion: 2024-05-31
• Completion: 2024-05-31
• First posted: 2021-07-21
• Last updated: 2024-11-15

Locations

1 site across 1 country: Pakistan

Regulatory

• FDA-regulated drug study