Apixaban in Patients With Left Ventricular Thrombus

Left Ventricular Thrombus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05208398
• Other study ID #: IRB-2018-08
• Status: Completed
• Phase: Phase 3
• Start date: February 18, 2018
• Est. completion date: September 30, 2021

Study information

• Verified date: January 2022
• Source: Saud Al Babtain Cardiac Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: September 30, 2021
• Est. primary completion date: September 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Left Ventricular Thrombus
• Thrombosis

Intervention

Drug:
• Apixaban
5 mg twice daily, on top of standards of care.
• 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

Locations

Country	Name	City	State
Saudi Arabia	Saud AlBabtain Cardiac Center	Dammam

Sponsors (1)

Lead Sponsor	Collaborator
Saud Al Babtain Cardiac Center

Country where clinical trial is conducted

Saudi Arabia, 

Outcome

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