Rivaroxaban vErsus Warfarin for Antithrombotic TheRapy in Patients With LeFt Ventricular Thrombus After Acute STEMI

Rajaie Cardiovascular Medical and Research Center50 enrolled

Overview

The purpose of the study is to assess the safety and efficacy of rivaroxaban-based versus warfarin-based antithrombotic regimens on outcomes of patients with left ventricle thrombosis following acute ST elevation myocardial infarction at 3 months from enrollment in an open-label parallel groups pilot randomized clinical trial

Direct oral anticoagulants (DOACs), are currently recognized as the first-line treatment of AF and VTE in most clinical scenarios, distinguished by their short half-life, fast onset of action, fewer medication interactions, rare food interactions, and the lack of a need for frequent laboratory monitoring, compared with vitamin K antagonists. Although the use of DOACs has earned a class III recommendation for patients with mechanical prosthetic valves, moderate-to-severe mitral stenosis, and antiphospholipid syndrome, their application in some situations, such as acute limb ischemia and LVT, remains uncertain. Until now, no completed randomized clinical trial has compared the efficacy and safety of left ventricle thrombosis in patients with acute STEMI and the existing evidence is limited to observational studies.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Left Ventricular Thrombus ST Segment Elevation Myocardial Infarction

Interventions

Rivaroxaban 15 MGDRUG

Rivaroxaban 15 MG once daily orally + Dual anti-platelet therapy (clopidogrel (75 mg daily, orally)+aspirin (80 mg once daily, orally))

WarfarinDRUG

Warfarin (to reach an INR goal of 2-2.5)+ Dual anti-platelet therapy (clopidogrel (75 mg daily, orally)+aspirin (80 mg once daily, orally))

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion criteria 1. Adult patients aged 18-80 years 2. Admission with acute STEMI in past 2 weeks 3. Acute LVT confirmed by non-contrast TTE 4. Willingness to participate and to provide a signed informed consent form Exclusion criteria 1. History of the mechanical prosthetic heart valve, rheumatic heart disease, and confirmed case of antiphospholipid syndrome 2. Active bleeding 3. Cardiogenic shock defined as persistent hypotension (systolic blood pressure \<90 mm Hg, or requirement of vasopressor to maintain systolic pressure \>90 mm Hg) and clinical signs of hypoperfusion (cold, sweated extremities, oliguria, mental confusion, dizziness, narrow pulse pressure) 4. Acute kidney injury or chronic kidney disease with a glomerular filtration rate \<30 ml/min (calculated based on the Cockcroft-Gault formula) 5. Liver failure (Child-Pugh class C) 6. Other indications for chronic anticoagulation (e.g., AF, VTE, etc.) 7. Sensitivity or intolerance to rivaroxaban/warfarin

Locations (2)

Rajaie Cardiovascular Medical and Research Center

Tehran, Iran

Tehran Heart Center

Tehran, Iran

Outcomes

Primary Outcomes

Resolution of left ventricular thrombus

Resolution of left ventricular thrombus according to non-contrast 2D TTE performed by the imaging core laboratory, blinded to the allocation assignment

Time frame: at 3 months from enrollment

Data from ClinicalTrials.gov

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