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Apixaban Versus Warfarin in Patients With Left Ventricular Thrombus

Primary Purpose

Left Ventricular Thrombosis

Status

Completed

Phase

Phase 3

Locations

Malaysia

Study Type

Interventional

Intervention

Apixaban 5 MG Oral Tablet [ELIQUIS]

Warfarin Sodium

About this trial

This is an interventional treatment trial for Left Ventricular Thrombosis

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Hospital Universiti Sains Malaysia

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

warfarin sodium

apixaban

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.

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

Life Threatening Bleeding

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

Full Information

NCT ID

NCT02982590

First Posted

November 21, 2016

Last Updated

June 15, 2021

Sponsor

Universiti Sains Malaysia

Collaborators

Institut Jantung Negara

1. Study Identification

Unique Protocol Identification Number

NCT02982590

Brief Title

Apixaban Versus Warfarin in Patients With Left Ventricular Thrombus

Official 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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2021

Overall Recruitment Status

Completed

Study Start Date

November 2016 (Actual)

Primary Completion Date

November 2018 (Actual)

Study Completion Date

November 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Universiti Sains Malaysia

Collaborators

Institut Jantung Negara

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Left Ventricular Thrombosis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

27 (Actual)

8. Arms, Groups, and Interventions

Arm Title

warfarin sodium

Arm Type

Active Comparator

Arm Description

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

Arm Title

apixaban

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Apixaban 5 MG Oral Tablet [ELIQUIS]

Other Intervention Name(s)

ELIQUIS

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Warfarin Sodium

Other Intervention Name(s)

Coumadin

Intervention Description

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

Primary Outcome Measure Information:

Title

Percent Change in Left Ventricular Thrombus (LVT) Size

Description

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

Time Frame

3 months

Secondary Outcome Measure Information:

Title

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

Description

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

Time Frame

3 months

Title

Clinically Definite Cardiac Embolic Ischemic Stroke

Description

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

Time Frame

3 months

Title

Life Threatening Bleeding

Description

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

Time Frame

3 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Dr W. Yus Haniff W. Isa, M.MED

Organizational Affiliation

Universiti Sains Malaysia

Official's Role

Principal Investigator

Facility Information:

Facility Name

Hospital Universiti Sains Malaysia

City

Kota Bharu

State/Province

Kelanatan

ZIP/Postal Code

16150

Country

Malaysia

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Apixaban Versus Warfarin in Patients With Left Ventricular Thrombus

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