Apixaban Versus Warfarin in Patients With Left Ventricular Thrombus

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

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.

Study Overview

• Status: Completed
• Conditions: Left Ventricular Thrombosis
• Intervention / Treatment: Drug: Warfarin Sodium; Drug: Apixaban 5 MG Oral Tablet [ELIQUIS]

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 27
• Phase: Phase 3

Contacts and Locations

Study Locations

• Malaysia
  • Kelanatan
    • Kota Bharu, Kelanatan, Malaysia, 16150
      • Hospital Universiti Sains Malaysia

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:

1. Age 18 - 80 years old
2. Presence of LV thrombus or spontaneous echo contrast (SEC) grade 3 or 4 (Patel VG 1996), with regional wall motion abnormalities
3. HASBLED score less than 3
4. 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:

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

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
Active Comparator: warfarin sodium; warfarin daily, dosage according to INR monitor. Aim INR 2-3	Drug: Warfarin Sodium; as controlled arm since warfarin is the standard therapy for LV thrombus; Other Names: Coumadin
Experimental: apixaban; Apixaban 5 MG Oral Tablet [ELIQUIS] will be given for randomly selected patients for 3 months.	Drug: Apixaban 5 MG Oral Tablet [ELIQUIS]; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent Change in Left Ventricular Thrombus (LVT) Size	Percentage of change in left ventricular thrombus (LVT) size after 12 weeks of Warfarin or Apixaban treatment	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of Left Ventricular Thrombosis (LVT) by More Than 50%	Percentage of participants who achieved left ventricular thrombus (LVT) reduction more than 50% in both Warfarin and Apixaban arms.	3 months
Clinically Definite Cardiac Embolic Ischemic Stroke	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 months
Life Threatening Bleeding	Number of participants who experienced life threatening bleeding attributed to the use of anti-coagulation.	3 months

Collaborators and Investigators

• Sponsor: Universiti Sains Malaysia
• Collaborators: Institut Jantung Negara
• Investigators: Principal Investigator: Dr W. Yus Haniff W. Isa, M.MED, Universiti Sains Malaysia

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2016
• Primary Completion (Actual): November 1, 2018
• Study Completion (Actual): November 1, 2018

Study Registration Dates

• First Submitted: November 21, 2016
• First Submitted That Met QC Criteria: November 30, 2016
• First Posted (Estimate): December 5, 2016

Study Record Updates

• Last Update Posted (Actual): July 8, 2021
• Last Update Submitted That Met QC Criteria: June 15, 2021
• Last Verified: June 1, 2021

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: 304/PPSP/61313197

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No