Rivaroxaban in Left Ventricular Thrombus

NCT ID: NCT04970576

Last Updated: 2024-11-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 261 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-06-25
• Study Completion Date: 2024-05-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Treatment group

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

Group Type: EXPERIMENTAL

Rivaroxaban

Intervention Type: 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

Control group

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

Group Type: ACTIVE_COMPARATOR

Warfarin

Intervention Type: 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

Interventions

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

Intervention Type: DRUG

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

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Cardiovascular Diseases, Pakistan

OTHER

Sponsor Role: lead

Responsible Party

Jehangir Ali Shah

Associate Professor of Cardiology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jehangir A Shah, FCPS

Role: PRINCIPAL_INVESTIGATOR

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

Locations

National Institute of Cardiovascular Diseases

Karachi, Sindh, Pakistan

Countries

Pakistan

References

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.

Reference Type: RESULT

PMID: 33766266 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 40706143 (View on PubMed)

Other Identifiers

ERC-70/2021

Identifier Type: -

Identifier Source: org_study_id