NCT02982590

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
27

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Nov 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2016

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

November 21, 2016

Completed
14 days until next milestone

First Posted

Study publicly available on registry

December 5, 2016

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2018

Completed
2.7 years until next milestone

Results Posted

Study results publicly available

July 8, 2021

Completed
Last Updated

July 8, 2021

Status Verified

June 1, 2021

Enrollment Period

2 years

First QC Date

November 21, 2016

Results QC Date

April 27, 2021

Last Update Submit

June 15, 2021

Conditions

Left Ventricular Thrombosis

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

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

    3 months

  • Clinically Definite Cardiac Embolic Ischemic Stroke

    3 months

  • Life Threatening Bleeding

    3 months

Study Arms (2)

warfarin sodium

ACTIVE COMPARATOR

warfarin daily, dosage according to INR monitor. Aim INR 2-3

Drug: Warfarin Sodium

apixaban

EXPERIMENTAL

Apixaban 5 MG Oral Tablet \[ELIQUIS\] will be given for randomly selected patients for 3 months.

Drug: Apixaban 5 MG Oral Tablet [ELIQUIS]

Interventions

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.

Also known as: ELIQUIS
apixaban
Warfarin SodiumDRUG

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

Also known as: Coumadin
warfarin sodium

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Universiti Sains Malaysia

Kota Bharu, Kelanatan, 16150, Malaysia

Location

MeSH Terms

Interventions

apixabanTabletsWarfarin

Intervention Hierarchy (Ancestors)

Dosage FormsPharmaceutical Preparations4-HydroxycoumarinsCoumarinsBenzopyransPyransHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Limitations and Caveats

Sample size of the study was small due to the pilot nature of the study, being a single-center strict study and strict exclusion criteria. High rate of early angioplasty in this center also contributed to the low number of patients with left ventricle thrombus (LVT). Many patients with LVT were excluded because of their ill clinical condition on presentation, deranged renal/liver functions on diagnosis, organized or old LVT and other logistic issues.

Results Point of Contact

Title
DR W YUS HANIFF W ISA
Organization
HOSPITAL UNIVERSITI SAINS MALAYSIA
wyhaniff@usm.my
09-767 3000

Study Officials

  • Dr W. Yus Haniff W. Isa, M.MED

    Universiti Sains Malaysia

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
DR

Study Record Dates

First Submitted

November 21, 2016

First Posted

December 5, 2016

Study Start

November 1, 2016

Primary Completion

November 1, 2018

Study Completion

November 1, 2018

Last Updated

July 8, 2021

Results First Posted

July 8, 2021

Record last verified: 2021-06

Data Sharing

IPD Sharing
Will not share

Locations

MY(1)