Apixaban Versus Warfarin in Patients With Left Ventricular Thrombus

Left Ventricular Thrombosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02982590
• Other study ID #: 304/PPSP/61313197
• Status: Completed
• Phase: Phase 3
• Start date: November 2016
• Est. completion date: November 2018

Study information

• Verified date: June 2021
• Source: Universiti Sains Malaysia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: November 2018
• Est. primary completion date: November 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Left Ventricular Thrombosis
• Thrombosis

Intervention

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.
• Warfarin Sodium
as controlled arm since warfarin is the standard therapy for LV thrombus

Locations

Country	Name	City	State
Malaysia	Hospital Universiti Sains Malaysia	Kota Bharu	Kelanatan

Sponsors (2)

Lead Sponsor	Collaborator
Universiti Sains Malaysia	Institut Jantung Negara

Country where clinical trial is conducted

Malaysia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Life Threatening Bleeding	Number of participants who experienced life threatening bleeding attributed to the use of anti-coagulation.	3 months