Apixaban in Patients With Left Ventricular Thrombus

Saud Al Babtain Cardiac Center

Status and phase: Completed; Phase 3

Conditions: Left Ventricular Thrombus

Treatments: Drug: Apixaban; Drug: Warfarin

Study type: Interventional

Funder types: Other

Identifiers

NCT05208398

IRB-2018-08

Details and patient eligibility

About

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).

Enrollment: 50 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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50 participants in 2 patient groups

Apixaban

Experimental group

Description:

Apixaban, 5 mg oral tablets, on top of updated guidelines of acute coronary syndrome management recommendations

Treatment:

Drug: Apixaban

Warfarin

Active Comparator group

Description:

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

Treatment:

Drug: Warfarin