Skip to main content
OpenTrials
Completed

NCT Number: NCT05208398

Apixaban in Patients With Left Ventricular Thrombus

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).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Left Ventricular Thrombus

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Saud AlBabtain Cardiac Center

Dammam, Saudi Arabia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Apixaban

Drug

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

Other names: Eliquis

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

Primary outcomes

  1. Resolution of left ventricular thrombus

    Time frame: 3 months

    Transthoracic, noncontrast, echocardiographic assessment.

Secondary outcomes

  1. Resolution of left ventricular thrombus

    Time frame: 6 months

    Transthoracic, noncontrast, echocardiographic assessment.

  2. Safety outcome

    Time frame: 3-6 months

    Major Adverse Cardiovascular Events (MACE) or any relevant bleeding according to the Bleeding Academic Research Consortium (BARC) classification

Sponsors and collaborators

Lead sponsor

Saud Al Babtain Cardiac Center

Other Gov

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Jan 26, 2022
Registry last updated
Jan 26, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.