Apixaban Versus Warfarin in Patients With Left Ventricular Thrombus
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|ClinicalTrials.gov Identifier: NCT02982590|
Recruitment Status : Completed
First Posted : December 5, 2016
Results First Posted : July 8, 2021
Last Update Posted : July 8, 2021
|Condition or disease||Intervention/treatment||Phase|
|Left Ventricular Thrombosis||Drug: Apixaban 5 MG Oral Tablet [ELIQUIS] Drug: Warfarin Sodium||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||27 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|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|
|Actual Study Start Date :||November 2016|
|Actual Primary Completion Date :||November 2018|
|Actual Study Completion Date :||November 2018|
Active Comparator: warfarin sodium
warfarin daily, dosage according to INR monitor. Aim INR 2-3
Drug: Warfarin Sodium
as controlled arm since warfarin is the standard therapy for LV thrombus
Other Name: Coumadin
Apixaban 5 MG Oral Tablet [ELIQUIS] will be given for randomly selected patients for 3 months.
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.
Other Name: ELIQUIS
- Percent Change in Left Ventricular Thrombus (LVT) Size [ Time Frame: 3 months ]Percentage of change in left ventricular thrombus (LVT) size after 12 weeks of Warfarin or Apixaban treatment
- Change of Left Ventricular Thrombosis (LVT) by More Than 50% [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 3 months ]Number of participants who experienced life threatening bleeding attributed to the use of anti-coagulation.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02982590
|Hospital Universiti Sains Malaysia|
|Kota Bharu, Kelanatan, Malaysia, 16150|
|Principal Investigator:||Dr W. Yus Haniff W. Isa, M.MED||Universiti Sains Malaysia|