Rivaroxaban in Left Ventricular Thrombus

Acute Coronary Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04970576
• Other study ID #: ERC-70/2021
• Status: Recruiting
• Phase: Phase 4
• Start date: June 25, 2021
• Est. completion date: January 30, 2024

Study information

• Verified date: November 2023
• Source: National Institute of Cardiovascular Diseases, Pakistan
• Contact: Jehangir A Shah, FCPS
• Phone: +923332608751
• Email: dr_shah_80[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 320
• Est. completion date: January 30, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Left Ventricular Thrombus
• Thrombosis

Intervention

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
• 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

Locations

Country	Name	City	State
Pakistan	National Institute of Cardiovascular Diseases	Karachi	Sindh

Sponsors (1)

Lead Sponsor	Collaborator
National Institute of Cardiovascular Diseases, Pakistan

Country where clinical trial is conducted

Pakistan, 

References & Publications (1)

Abdelnabi M, Saleh Y, Fareed A, Nossikof A, Wang L, Morsi M, Eshak N, Abdelkarim O, Badran H, Almaghraby A. Comparative Study of Oral Anticoagulation in Left Ventricular Thrombi (No-LVT Trial). J Am Coll Cardiol. 2021 Mar 30;77(12):1590-1592. doi: 10.1016 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Left ventricular (LV) thrombus	Presence or absence of LV thrombus on transthoracic echocardiographic	After 12 weeks of randomization
Secondary	Stroke or systemic embolism	Confirmed on computerized tomography (CT) scan	Within 12 weeks of randomization
Secondary	Major bleeding	As per the International Society on Thrombosis and Haemostasis (ISTH) criteria	Within 12 weeks of randomization