Clinical trial NCT04970576: Rivaroxaban in Left Ventricular Thrombus
Official title: Efficacy of Rivaroxaban in Patients With Left Ventricular Thrombus After Acute Myocardial Infarction: An Open Label Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Acute Coronary Syndrome
Left Ventricular Thrombus
Lead sponsor: National Institute of Cardiovascular Diseases, Pakistan
Sponsor class: OTHER
First posted: 2021-07-21
Enrollment: 261
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Left ventricular (LV) thrombus
timeFrame: After 12 weeks of randomization
Secondary outcomes:
measure: Stroke or systemic embolism
timeFrame: Within 12 weeks of randomization
measure: Major bleeding
timeFrame: Within 12 weeks of randomization
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: National Institute of Cardiovascular Diseases
state: Sindh
Study officials:
affiliation: National Institute of Cardiovascular Diseases (NICVD), Karachi, Pakistan
name: Jehangir A Shah, FCPS
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.