Safety and Efficacy of Periprocedural Apixaban Use for Reduction of the Risk of Cerebrovascular Events in Patients Undergoing Ventricular Tachycardia Radiofrequency Catheter Ablation (STROKE-VT)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02666742|
Recruitment Status : Terminated (Investigator left Institution.)
First Posted : January 28, 2016
Last Update Posted : May 23, 2018
|Condition or disease||Intervention/treatment||Phase|
|Ventricular Tachycardia||Drug: Apixaban Drug: Aspirin||Phase 4|
Ventricular tachycardia (VT) or fast heart rhythm is a condition where the lower chambers (ventricles) of the heart beat too fast. This condition can be life threatening because these ventricles are the main pumping chambers of the heart. The fast heartbeat is caused by electrical impulses that travel incorrectly in your heart.
One way to treat VT is to have a catheter ablation procedure. A catheter ablation is a procedure that creates scar tissue in the heart to interrupt the electrical impulses that create irregular heart rhythms.
It is possible that the ablation procedure might cause a blood clot to form. The blood clot can stop blood flow to the brain and cause a stroke. When blood flow is interrupted to a certain part of the brain, that part does not receive enough oxygen. As a result of the stroke the affected areas of the brain are unable to function normally.
Apixaban (also known as Eliquis) is a blood thinning drug, also called an anticoagulant. It interferes with the body's natural blood clotting ability by inactivating a specific enzyme that the body needs to form blood clots.
Participation in this study will last about 30 days.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||4 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Safety and Efficacy of Periprocedural Apixaban Use for Reduction of the Risk of Cerebrovascular Events in Patients Undergoing Ventricular Tachycardia Radiofrequency Catheter Ablation|
|Actual Study Start Date :||February 16, 2017|
|Actual Primary Completion Date :||May 1, 2018|
|Actual Study Completion Date :||May 1, 2018|
Participants will be asked to take 5 milligrams by mouth twice per day.
Apixaban is a blood thinning drug, also called an anticoagulant. Apixaban is approved by the U.S. Food and Drug Administration (FDA) for the treatment of deep vein thrombosis and pulmonary embolism, which are blood clots in the veins or lungs.
Other Name: Eliquis
Active Comparator: Aspirin
Participants will be asked to take 81 milligrams by mouth once per day.
Aspirin works by reducing substances in the body that cause pain, fever, and inflammation. Aspirin is used to treat pain, and reduce fever or inflammation.
- Incidence of asymptomatic or symptomatic cerebrovascular embolic and systemic thromboembolic events [ Time Frame: Day 30 ]
- Incidence of major periprocedural bleeding [ Time Frame: Day 30 ]
- Incidence of minor periprocedural bleeding [ Time Frame: Day 30 ]
- All cause mortality [ Time Frame: Day 30 ]
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): NCT02666742
|United States, Kansas|
|University of Kansas Medical Center|
|Kansas City, Kansas, United States, 66160|
|Principal Investigator:||Dhanunjaya Lakkireddy, MD||University of Kansas Medical Center|