Skip to main content
OpenTrials
Completed

NCT Number: NCT02982590

Apixaban Versus Warfarin in Patients With Left Ventricular Thrombus

The purpose of this study is to compare the novel oral anticoagulant apixaban with the standard therapy of warfarin on the size reduction or resolution of left ventricular thrombus over 3 months.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Hospital Universiti Sains Malaysia

Kota Bharu, Kelanatan, 16150, Malaysia

About this study

Current treatment for left ventricular thrombus is anti-coagulant or blood thinning agent known as warfarin. Recently at least three novel oral anticoagulant agents were used in the treatment of atrial fibrillation, pulmonary embolism and deep vein thrombosis (DVT).

Novel oral anticoagulant drugs will require no blood taking for INR monitoring, hence less visit and more convenience to patients. Latest studies also showed lesser rate of bleeding as compared to warfarin and hence relatively safer.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age 18 - 80 years old
  • Presence of LV thrombus or spontaneous echo contrast (SEC) grade 3 or 4 (Patel VG 1996), with regional wall motion abnormalities
  • HASBLED score less than 3
  • No episodes of major bleeding in the past 6 months a) Major bleeding defined as i. episodes of bleeding with significant drop in haemoglobin(Hb)level of at least 2gm/dL - Includes upper and lower gastrointestinal bleed ii. The need for blood transfusion (pack cell) of at least 2 unit iii. Recent surgery with bleeding complications and lost of Hb as in (i) or (ii) iv. Any intracranial bleeds with neurological deficits

Exclusion criteria

  • Patient with unstable arrhythmias and/or recurrent cardiogenic shock
  • Patient with large ischemic stroke on recruitment-defined as involving >1/3 of cerebral hemisphere or deemed to have high chance of haemorrhagic transformation
  • Patient with permanent pacemaker
  • Patient who is post valve replacement therapy
  • Patient who is pregnant.
  • Patient with advanced kidney disease at stage V and not on dialysis (CrCl <15 mL/min)
  • Patient with advanced liver disease with coagulopathy
  • Patient with organized and old left ventricular thrombus

Treatment and study plan

Apixaban 5 MG Oral Tablet [ELIQUIS]

Drug

Apixaban is licensed for treatment of deep vein thrombosis and pulmonary embolism. Hence, a good study drug for left ventricular thrombosis for possibility of a new indication.

Other names: ELIQUIS

Warfarin sodium

Drug

as controlled arm since warfarin is the standard therapy for LV thrombus

Other names: Coumadin

Primary outcomes

  1. Percent Change in Left Ventricular Thrombus (LVT) Size

    Time frame: 3 months

    Percentage of change in left ventricular thrombus (LVT) size after 12 weeks of Warfarin or Apixaban treatment

Secondary outcomes

  1. Change of Left Ventricular Thrombosis (LVT) by More Than 50%

    Time frame: 3 months

    Percentage of participants who achieved left ventricular thrombus (LVT) reduction more than 50% in both Warfarin and Apixaban arms.

  2. Clinically Definite Cardiac Embolic Ischemic Stroke

    Time frame: 3 months

    Number of participants who showed evidence of clinically definite cardiac embolic ischemic stroke (focal neurological deficits persisting for more than 24 hours) confirmed by CT scan

  3. Life Threatening Bleeding

    Time frame: 3 months

    Number of participants who experienced life threatening bleeding attributed to the use of anti-coagulation.

Sponsors and collaborators

Lead sponsor

Universiti Sains Malaysia

Other

Collaborators

  • Institut Jantung Negara

Registry information

Official study title

Apixaban Versus Warfarin in Patients With Left Ventricular Thrombus: A Prospective Randomized Outcome Blinded Study on the Size Reduction or Resolution of Left Ventricular Thrombus

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Dec 5, 2016
Registry last updated
Jul 8, 2021

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.

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