Apixaban Versus Warfarin in Patients With Left Ventricular Thrombus

• Status: Completed
• Trial end date: 2018-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Universiti Sains Malaysia; University of Science Malaysia
• Collaborator: Institut Jantung Negara
• Treatments: Apixaban; Warfarin

Criteria

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