Rivaroxaban in Left Ventricular Thrombus

NCT04970576 | Completed Phase 4 DMC FDA Drug

• 1 other identifier: ERC-70/2021
• Study Type: interventional
• Target: 261
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Coronary Syndrome; Left Ventricular Thrombus

Outcome Measures

Primary Outcomes (1)

• Left ventricular (LV) thrombus

  Presence or absence of LV thrombus on transthoracic echocardiographic

  After 12 weeks of randomization

Secondary Outcomes (2)

• Stroke or systemic embolism

  Within 12 weeks of randomization

• Major bleeding

  Within 12 weeks of randomization

Study Arms (2)

Treatment group

EXPERIMENTAL

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

Drug: Rivaroxaban

Control group

ACTIVE COMPARATOR

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

Drug: Warfarin

Interventions

Rivaroxaban DRUG

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

Treatment group

Warfarin DRUG

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

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Institute of Cardiovascular Diseases, Pakistan: lead

Study Sites (1)

National Institute of Cardiovascular Diseases

Karachi, Sindh, 75510, Pakistan

Location

Related Publications (2)

• 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/j.jacc.2021.01.049. No abstract available.

  PMID: 33766266 RESULT

• Shah JA, Hussain J, Ahmed B, Batra MK, Ali G, Naz M, Khan W, Bhatti KI, Karim M, Hakeem A. Rivaroxaban vs Warfarin in Acute Left Ventricular Thrombus Following Myocardial Infarction: RIVAWAR, An Open-Label RCT. JACC Adv. 2025 Aug;4(8):101978. doi: 10.1016/j.jacadv.2025.101978. Epub 2025 Jul 23.

  PMID: 40706143 DERIVED

MeSH Terms

Conditions

Acute Coronary Syndrome

Interventions

Rivaroxaban; Warfarin

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Morpholines; Oxazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; 4-Hydroxycoumarins; Coumarins; Benzopyrans; Pyrans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Jehangir A Shah, FCPS

  National Institute of Cardiovascular Diseases (NICVD), Karachi, Pakistan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Transthoracic echocardiography assessment for the dissolution of LV thrombus will be blinded to the treatment group
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Cardiology

Study Record Dates

• First Submitted: July 10, 2021
• First Posted: July 21, 2021
• Study Start: June 25, 2021
• Primary Completion: May 31, 2024
• Study Completion: May 31, 2024
• Last Updated: November 15, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)