Apixaban in Patients With Left Ventricular Thrombus

NCT05208398 | Completed Phase 3 DMC

• 1 other identifier: IRB-2018-08
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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).

Conditions

Left Ventricular Thrombus

Outcome Measures

Primary Outcomes (1)

• Resolution of left ventricular thrombus

  Transthoracic, noncontrast, echocardiographic assessment.

  3 months

Secondary Outcomes (2)

• Resolution of left ventricular thrombus

  6 months

• Safety outcome

  3-6 months

Study Arms (2)

Apixaban

EXPERIMENTAL

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

Drug: Apixaban

Warfarin

ACTIVE COMPARATOR

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

Interventions

Apixaban DRUG

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

Also known as: Eliquis

Apixaban

Warfarin DRUG

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

Warfarin

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Saud Al Babtain Cardiac Center: lead

Study Sites (1)

Saud AlBabtain Cardiac Center

Dammam, Saudi Arabia

Location

MeSH Terms

Interventions

apixaban; Warfarin

Intervention Hierarchy (Ancestors)

4-Hydroxycoumarins; Coumarins; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: Open label randomized controlled clinical trial, two parallel active groups, with blinded primary study outcome assessor.

Study Record Dates

• First Submitted: December 23, 2021
• First Posted: January 26, 2022
• Study Start: February 18, 2018
• Primary Completion: September 30, 2021
• Study Completion: September 30, 2021
• Last Updated: January 26, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

SA (1)