Apixaban in Patients With Left Ventricular Thrombus

Phase 3CompletedNCT05208398

Saud Al Babtain Cardiac Center50 enrolled

Overview

Open label randomized controlled clinical trial to evaluate the efficacy and safety of apixaban versus warfarin in treating left ventricular thrombus in patients with acute or recent myocardial infarction (MI).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Left Ventricular Thrombus

Interventions

ApixabanDRUG

5 mg twice daily, on top of standards of care.

WarfarinDRUG

Warfarin, oral tablets, to achieve international normalized ratio (INR) of 2-3, on top of standards of care, as per updated guidelines of acue coronary syndrome management recommendations

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: All the following criteria must be fulfilled: * Ages between 18 and 80 years, * History of anterior wall MI, either acute (within a week) or recent (within a month) * Evident left ventricular thrombus (LVT) by transthoracic echocardiography, * Naïve to oral anticoagulants (OAC) * stable to start OAC Exclusion Criteria: * Other indications for OAC, * Patients with contraindications for OAC, * Right ventricular thrombus or atrial thrombus, * History of confirmed stroke or other systemic embolization within the previous six months, * High bleeding risk, * Severe renal impairment, * Patients with expected difficulties to follow the INR strictly.

Locations (1)

Saud AlBabtain Cardiac Center

Dammam, Saudi Arabia

Outcomes

Primary Outcomes

Resolution of left ventricular thrombus

Transthoracic, noncontrast, echocardiographic assessment.

Time frame: 3 months

Secondary Outcomes

Resolution of left ventricular thrombus

Transthoracic, noncontrast, echocardiographic assessment.

Time frame: 6 months

Safety outcome

Major Adverse Cardiovascular Events (MACE) or any relevant bleeding according to the Bleeding Academic Research Consortium (BARC) classification

Time frame: 3-6 months

Data from ClinicalTrials.gov

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