Apixaban in Patients With Left Ventricular Thrombus

Phase 3

Completed

• Conditions: Left Ventricular Thrombus
• Interventions: Drug: Apixaban; Drug: Warfarin

• Registration Number: NCT05208398
• Lead Sponsor: Saud Al Babtain Cardiac Center

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2018-02-18
• Primary Completion: 2021-09-30
• Study Completion: 2021-09-30
• Study First Submitted: 2021-12-23
• Status Verified: 2022-01
• Study First Submitted QC: 2022-01-12
• Last Update Submitted: 2022-01-12
• Study First Posted: 2022-01-26
• Last Update Posted: 2022-01-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Resolution of left ventricular thrombus	3 months	Transthoracic, noncontrast, echocardiographic assessment.

Secondary Outcome Measures

Name	Time	Method
Resolution of left ventricular thrombus	6 months	Transthoracic, noncontrast, echocardiographic assessment.
Safety outcome	3-6 months	Major Adverse Cardiovascular Events (MACE) or any relevant bleeding according to the Bleeding Academic Research Consortium (BARC) classification

Trial Locations

Locations (1)

Saud AlBabtain Cardiac Center; 🇸🇦 Dammam, Saudi Arabia