Apixaban Versus Warfarin in Patients With Left Ventricular Thrombus

Phase 3

Completed

• Conditions: Left Ventricular Thrombosis
• Interventions: Drug: Apixaban 5 MG Oral Tablet [ELIQUIS]; Drug: Warfarin Sodium

• Registration Number: NCT02982590
• Lead Sponsor: Universiti Sains Malaysia

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.

Study Timeline

• Study Start: 2016-11
• Study First Submitted: 2016-11-21
• Study First Submitted QC: 2016-11-30
• Study First Posted: 2016-12-05
• Primary Completion: 2018-11
• Study Completion: 2018-11
• Results First Submitted: 2021-04-27
• Status Verified: 2021-06
• Results First Submitted QC: 2021-06-15
• Last Update Submitted: 2021-06-15
• Results First Posted: 2021-07-08
• Last Update Posted: 2021-07-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 27

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
apixaban	Apixaban 5 MG Oral Tablet [ELIQUIS]	Apixaban 5 MG Oral Tablet \[ELIQUIS\] will be given for randomly selected patients for 3 months.
warfarin sodium	Warfarin Sodium	warfarin daily, dosage according to INR monitor. Aim INR 2-3

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Life Threatening Bleeding	3 months	Number of participants who experienced life threatening bleeding attributed to the use of anti-coagulation.
Change of Left Ventricular Thrombosis (LVT) by More Than 50%	3 months	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	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

Trial Locations

Locations (1)

Hospital Universiti Sains Malaysia; 🇲🇾 Kota Bharu, Kelanatan, Malaysia