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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
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04970576
Enrollment
261
Registered
2021-07-21
Start date
2021-06-25
Completion date
2024-05-31
Last updated
2024-11-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Coronary Syndrome, Left Ventricular Thrombus

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.

Interventions

DRUGRivaroxaban

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

DRUGWarfarin

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

Sponsors

National Institute of Cardiovascular Diseases, Pakistan
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Masking description

Transthoracic echocardiography assessment for the dissolution of LV thrombus will be blinded to the treatment group

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Left ventricular (LV) thrombusAfter 12 weeks of randomizationPresence or absence of LV thrombus on transthoracic echocardiographic

Secondary

MeasureTime frameDescription
Stroke or systemic embolismWithin 12 weeks of randomizationConfirmed on computerized tomography (CT) scan
Major bleedingWithin 12 weeks of randomizationAs per the International Society on Thrombosis and Haemostasis (ISTH) criteria

Countries

Pakistan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 11, 2026