Hospital Universiti Sains Malaysia
Kota Bharu, Kelanatan, 16150, Malaysia
NCT Number: NCT02982590
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.
Looking for future studies?
Notify Me18 year–80 year
All sexes
Interventional
Phase 3
Kota Bharu, Kelanatan, 16150, Malaysia
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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 names: ELIQUIS
as controlled arm since warfarin is the standard therapy for LV thrombus
Other names: Coumadin
Time frame: 3 months
Percentage of change in left ventricular thrombus (LVT) size after 12 weeks of Warfarin or Apixaban treatment
Time frame: 3 months
Percentage of participants who achieved left ventricular thrombus (LVT) reduction more than 50% in both Warfarin and Apixaban arms.
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
Time frame: 3 months
Number of participants who experienced life threatening bleeding attributed to the use of anti-coagulation.
Universiti Sains Malaysia
Other
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
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT03232398
Acute Myocardial Infarction, Anticoagulants and Bleeding Disorders
Jerusalem, Israel
View Trial DetailsNCT03926780
Anticoagulants; Increased, Left Ventricular Thrombosis
Alexandria, Egypt
View Trial Details