Rivaroxaban in Left Ventricular Thrombus

Sponsor

National Institute of Cardiovascular Diseases, Karachi (Other)

Overall Status

Recruiting

CT.gov ID

NCT04970576

Collaborator

(none)

320

Enrollment

Location

Arms

11.1

Anticipated Duration (Months)

28.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Acute Coronary Syndrome Left Ventricular Thrombus	Drug: Rivaroxaban Drug: Warfarin	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

320 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Masking Description:

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

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jun 25, 2021

Anticipated Primary Completion Date :

May 30, 2022

Anticipated Study Completion Date :

May 30, 2022

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: Treatment group

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

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

Active Comparator: Control group

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

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

Outcome Measures

Primary Outcome Measures

Left ventricular (LV) thrombus [After 12 weeks of randomization]
Presence or absence of LV thrombus on transthoracic echocardiographic

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	National Institute of Cardiovascular Diseases	Karachi	Sindh	Pakistan	75510

Sponsors and Collaborators

National Institute of Cardiovascular Diseases, Karachi

Investigators

Principal Investigator: Jehangir A Shah, FCPS, National Institute of Cardiovascular Diseases (NICVD), Karachi, Pakistan

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Jehangir Ali Shah, Assistant Professor of Cardiology, National Institute of Cardiovascular Diseases, Karachi

ClinicalTrials.gov Identifier:

NCT04970576

Other Study ID Numbers:

ERC-70/2021

First Posted:

Jul 21, 2021

Last Update Posted:

Jul 21, 2021

Last Verified:

Jul 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Yes

Additional relevant MeSH terms:

Acute Coronary Syndrome

Thrombosis

Warfarin

Rivaroxaban

Study Results

No Results Posted as of Jul 21, 2021