Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Institut Jantung Negara | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| warfarin sodium | Active Comparator | warfarin daily, dosage according to INR monitor. Aim INR 2-3 |
|
| apixaban | Experimental | Apixaban 5 MG Oral Tablet [ELIQUIS] will be given for randomly selected patients for 3 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Apixaban 5 MG Oral Tablet [ELIQUIS] | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Clinically Definite Cardiac Embolic Ischemic Stroke |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Dr W. Yus Haniff W. Isa, M.MED | Universiti Sains Malaysia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universiti Sains Malaysia | Kota Bharu | Kelanatan | 16150 | Malaysia |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Gender, Age, Co-morbidities, HAS-BLED score
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | Apixaban |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Posted | Mean | Standard Deviation | percentage of change | 3 months |
|
24 months
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death | Cardiac disorders | Systematic Assessment | Worsening heart failure. Died in hospital. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Epistaxis | General disorders | Systematic Assessment |
Sample size of the study was small due to the pilot nature of the study, being a single-center strict study and strict exclusion criteria.
High rate of early angioplasty in this center also contributed to the low number of patients with left ventricle thrombus (LVT).
Many patients with LVT were excluded because of their ill clinical condition on presentation, deranged renal/liver functions on diagnosis, organized or old LVT and other logistic issues.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| DR W YUS HANIFF W ISA | HOSPITAL UNIVERSITI SAINS MALAYSIA | 09-767 3000 | wyhaniff@usm.my |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Dec 12, 2015 | Jun 9, 2021 | Prot_SAP_ICF_000.pdf |
Not provided
| ID | Term |
|---|---|
| C522181 | apixaban |
| D013607 | Tablets |
| D014859 | Warfarin |
| ID | Term |
|---|---|
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
| D015110 | 4-Hydroxycoumarins |
| D003374 | Coumarins |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Warfarin Sodium | Drug | as controlled arm since warfarin is the standard therapy for LV thrombus |
|
|
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 |
| Life Threatening Bleeding | Number of participants who experienced life threatening bleeding attributed to the use of anti-coagulation. | 3 months |
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.
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Comorbidities | Count of Participants | Participants |
|
| HAS-BLED score | Hypertension, Abnormal renal or liver function, Stroke, Bleeding, Labile INR, Elderly, Drugs or alcohol (HAS-BLED) score estimates the 1-year risk of major bleeding for patients on anticoagulation to assess risk-benefit in atrial fibrillation care. Minimum score = 0, maximum score = 9. Score of 0 to 1: Low risk for major bleeding. Score of 2: Moderate risk for major bleeding. Score ≥ 3: High risk for major bleeding. In our study, we exclude patients with HAS-BLED score > 3. Thus, only patients with HAS-BLED score from 0 to 3 were recruited. | Mean | Standard Deviation | total score |
|
|
|
| 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. | Posted | Number | percentage of participants | 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 | Posted | Count of Participants | Participants | 3 months |
|
|
|
| Secondary | Life Threatening Bleeding | Number of participants who experienced life threatening bleeding attributed to the use of anti-coagulation. | Posted | Count of Participants | Participants | 3 months |
|
|
|
| 4 |
| 13 |
| 4 |
| 13 |
| 1 |
| 13 |
| EG001 | 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. | 2 | 14 | 2 | 14 | 0 | 14 |
|
| Gastrointestinal bleeding and Death | Gastrointestinal disorders | Systematic Assessment | Admitted for upper GI bleeding with coagulopathy. Later develop worsening heart failure and died in hospital. |
|
| Sudden Death at home | Cardiac disorders | Systematic Assessment | Family informed patient died suddenly at home. |
|
| Ischemic Stroke with hemorrhagic transformation and death | Nervous system disorders | Systematic Assessment | Patient develop stroke after off Apixaban 48 hours following end of study. Complicated with hemorrhagic transformation and death. |
|
Not provided
Not provided
| D001578 |
| Benzopyrans |
| D011714 | Pyrans |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |