Left Ventricular Thrombosis
Conditions
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.
Interventions
DRUGApixaban 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.
DRUGWarfarin Sodium
as controlled arm since warfarin is the standard therapy for LV thrombus
Sponsors
Institut Jantung Negara
Universiti Sains Malaysia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Life Threatening Bleeding | 3 months | Number of participants who experienced life threatening bleeding attributed to the use of anti-coagulation. |
Countries
Malaysia
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Warfarin Sodium warfarin daily, dosage according to INR monitor. Aim INR 2-3
Warfarin Sodium: as controlled arm since warfarin is the standard therapy for LV thrombus | 13 |
| Apixaban Apixaban 5 MG Oral Tablet \[ELIQUIS\] will be given for randomly selected patients for 3 months.
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. | 14 |
| Total | 27 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 4 | 0 |
| Overall Study | Lost to Follow-up | 0 | 1 |
Baseline characteristics
| Characteristic | Warfarin Sodium | Apixaban | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 2 Participants | 1 Participants | 3 Participants |
| Age, Categorical Between 18 and 65 years | 11 Participants | 13 Participants | 24 Participants |
| Age, Continuous | 55.00 years STANDARD_DEVIATION 11.42 | 55.36 years STANDARD_DEVIATION 11.04 | 55.19 years STANDARD_DEVIATION 11.01 |
| Comorbidities Atrial fibrillation | 0 Participants | 1 Participants | 1 Participants |
| Comorbidities Chronic kidney disease | 7 Participants | 5 Participants | 12 Participants |
| Comorbidities Diabetes mellitus | 9 Participants | 7 Participants | 16 Participants |
| Comorbidities Hyperlipidemia | 9 Participants | 8 Participants | 17 Participants |
| Comorbidities Hypertension | 9 Participants | 8 Participants | 17 Participants |
| Comorbidities Ischemic heart disease | 8 Participants | 9 Participants | 17 Participants |
| HAS-BLED score | 1.46 total score STANDARD_DEVIATION 0.66 | 1.0 total score STANDARD_DEVIATION 0.68 | 1.22 total score STANDARD_DEVIATION 0.7 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 1 Participants | 1 Participants | 2 Participants |
| Sex: Female, Male Male | 12 Participants | 13 Participants | 25 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 4 / 13 | 2 / 14 |
| other Total, other adverse events | 1 / 13 | 0 / 14 |
| serious Total, serious adverse events | 4 / 13 | 2 / 14 |
Outcome results
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
Time frame: 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Warfarin Sodium | Percent Change in Left Ventricular Thrombus (LVT) Size | -61.45 percentage of change | Standard Deviation 43.95 |
| Apixaban | Percent Change in Left Ventricular Thrombus (LVT) Size | -65.08 percentage of change | Standard Deviation 31.34 |
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.
Time frame: 3 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Warfarin Sodium | Change of Left Ventricular Thrombosis (LVT) by More Than 50% | 77.7 percentage of participants |
| Apixaban | Change of Left Ventricular Thrombosis (LVT) by More Than 50% | 61.5 percentage of participants |
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
Time frame: 3 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Warfarin Sodium | Clinically Definite Cardiac Embolic Ischemic Stroke | 0 Participants |
| Apixaban | Clinically Definite Cardiac Embolic Ischemic Stroke | 1 Participants |
Secondary
Life Threatening Bleeding
Number of participants who experienced life threatening bleeding attributed to the use of anti-coagulation.
Time frame: 3 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Warfarin Sodium | Life Threatening Bleeding | 1 Participants |
| Apixaban | Life Threatening Bleeding | 0 Participants |