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Rivaroxaban in Left Ventricular Thrombus

NCT04970576 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 261

Last updated 2024-11-15

No results posted yet for this study

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

Interventions

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

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

Sponsors & Collaborators

  • National Institute of Cardiovascular Diseases, Pakistan

    lead OTHER

Principal Investigators

  • Jehangir A Shah, FCPS · National Institute of Cardiovascular Diseases (NICVD), Karachi, Pakistan

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-25
Primary Completion
2024-05-31
Completion
2024-05-31
FDA Drug
Yes

Countries

  • Pakistan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04970576 on ClinicalTrials.gov