Rivaroxaban in Left Ventricular Thrombus

National Institute of Cardiovascular Diseases, Pakistan

Status and phase: Completed; Phase 4

Conditions: Acute Coronary Syndrome; Left Ventricular Thrombus

Treatments: Drug: Warfarin; Drug: Rivaroxaban

Study type: Interventional

Funder types: Other

Identifiers

NCT04970576

ERC-70/2021

Details and patient eligibility

About

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.

Enrollment: 261 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients of acute coronary syndrome with LV thrombus
• Hemodynamically stable
• Willing to participate

Exclusion criteria

• Prior history of cardiomyopathy
• Anticoagulant contraindications
• Prior history of stroke with residual neurological deficit
• Valvular atrial fibrilation
• Pregnancy
• Mentally retarded
• Deranged liver function tests (LFTS)
• Creatinine Clearance <50 ml

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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261 participants in 2 patient groups

Treatment group

Experimental group

Description:

Patients in the intervention group will receive Rivaroxaban 20 mg once a day (OD) for three months

Treatment:

Drug: Rivaroxaban

Control group

Active Comparator group

Description:

Patients in the control group will receive usual warfarin therapy dose adjusted as per the target INR of 2 to 3

Treatment:

Drug: Warfarin