Clinical trial NCT02982590: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Left Ventricular Thrombosis
Lead sponsor: Universiti Sains Malaysia
Sponsor class: OTHER
Collaborators: name: Institut Jantung Negara
First posted: 2016-12-05
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Percent Change in Left Ventricular Thrombus (LVT) Size
timeFrame: 3 months
Secondary outcomes:
measure: Change of Left Ventricular Thrombosis (LVT) by More Than 50%
timeFrame: 3 months
measure: Clinically Definite Cardiac Embolic Ischemic Stroke
timeFrame: 3 months
measure: Life Threatening Bleeding
timeFrame: 3 months
Other outcomes:
Locations:
city: Kota Bharu
country: Malaysia
facility: Hospital Universiti Sains Malaysia
state: Kelanatan
Study officials:
affiliation: Universiti Sains Malaysia
name: Dr W. Yus Haniff W. Isa, M.MED
role: PRINCIPAL_INVESTIGATOR
References: