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OpenTrials
Completed

NCT Number: NCT04970576

Rivaroxaban in Left Ventricular Thrombus

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

National Institute of Cardiovascular Diseases

Karachi, Sindh, 75510, Pakistan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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

Primary outcomes

  1. Left ventricular (LV) thrombus

    Time frame: After 12 weeks of randomization

    Presence or absence of LV thrombus on transthoracic echocardiographic

Secondary outcomes

  1. Stroke or systemic embolism

    Time frame: Within 12 weeks of randomization

    Confirmed on computerized tomography (CT) scan

  2. Major bleeding

    Time frame: Within 12 weeks of randomization

    As per the International Society on Thrombosis and Haemostasis (ISTH) criteria

Sponsors and collaborators

Lead sponsor

National Institute of Cardiovascular Diseases, Pakistan

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Jul 21, 2021
Registry last updated
Nov 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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