Rivaroxaban in Left Ventricular Thrombus

Phase 4

Completed

• Conditions: Left Ventricular Thrombus; Acute Coronary Syndrome
• Interventions: Drug: Rivaroxaban; Drug: Warfarin

• Registration Number: NCT04970576
• Lead Sponsor: National Institute of Cardiovascular Diseases, Pakistan

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-06-25
• Study First Submitted: 2021-07-10
• Study First Submitted QC: 2021-07-10
• Study First Posted: 2021-07-21
• Primary Completion: 2024-05-31
• Study Completion: 2024-05-31
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-13
• Last Update Posted: 2024-11-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 261

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment group	Rivaroxaban	Patients in the intervention group will receive Rivaroxaban 20 mg once a day (OD) for three months
Control group	Warfarin	Patients in the control group will receive usual warfarin therapy dose adjusted as per the target INR of 2 to 3

Primary Outcome Measures

Name	Time	Method
Left ventricular (LV) thrombus	After 12 weeks of randomization	Presence or absence of LV thrombus on transthoracic echocardiographic

Secondary Outcome Measures

Name	Time	Method
Stroke or systemic embolism	Within 12 weeks of randomization	Confirmed on computerized tomography (CT) scan
Major bleeding	Within 12 weeks of randomization	As per the International Society on Thrombosis and Haemostasis (ISTH) criteria

Trial Locations

Locations (1)

National Institute of Cardiovascular Diseases; 🇵🇰 Karachi, Sindh, Pakistan