Apixaban in Patients With Left Ventricular Thrombus

Apixaban in Patients With Left Ventricular Thrombus Post Myocardial Infarction; A Randomized Clinical Trial

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 Overview

• Status: Completed
• Conditions: Left Ventricular Thrombus
• Intervention / Treatment: Drug: Apixaban; Drug: Warfarin

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Phase 3

Contacts and Locations

Study Locations

• Saudi Arabia
  • Dammam, Saudi Arabia
    • Saud AlBabtain Cardiac Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Apixaban; Apixaban, 5 mg oral tablets, on top of updated guidelines of acute coronary syndrome management recommendations	Drug: Apixaban; 5 mg twice daily, on top of standards of care.; Other Names: Eliquis
Active Comparator: 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	Drug: Warfarin; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Resolution of left ventricular thrombus	Transthoracic, noncontrast, echocardiographic assessment.	3 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Saud Al Babtain Cardiac Center

Study record dates

Study Major Dates

• Study Start (Actual): February 18, 2018
• Primary Completion (Actual): September 30, 2021
• Study Completion (Actual): September 30, 2021

Study Registration Dates

• First Submitted: December 23, 2021
• First Submitted That Met QC Criteria: January 12, 2022
• First Posted (Actual): January 26, 2022

Study Record Updates

• Last Update Posted (Actual): January 26, 2022
• Last Update Submitted That Met QC Criteria: January 12, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Embolism and Thrombosis; Thrombosis; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Protease Inhibitors; Factor Xa Inhibitors; Antithrombins; Serine Proteinase Inhibitors; Anticoagulants; Apixaban; Warfarin
• Other Study ID Numbers: IRB-2018-08

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: No plan to share.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No