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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)

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ClinicalTrials.gov Identifier: NCT02666742
Recruitment Status : Terminated (Investigator left Institution.)
First Posted : January 28, 2016
Last Update Posted : May 23, 2018
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
University of Kansas Medical Center

Brief Summary:
The purpose of this study is to learn if taking a drug called Apixaban after an ablation procedure keeps blood clots from forming and lowers the chance of having a stroke in patients with ventricular tachycardia (VT).

Condition or disease Intervention/treatment Phase
Ventricular Tachycardia Drug: Apixaban Drug: Aspirin Phase 4

Detailed Description:

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Apixaban
Participants will be asked to take 5 milligrams by mouth twice per day.
Drug: Apixaban
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.
Drug: Aspirin
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.




Primary Outcome Measures :
  1. Incidence of asymptomatic or symptomatic cerebrovascular embolic and systemic thromboembolic events [ Time Frame: Day 30 ]

Secondary Outcome Measures :
  1. Incidence of major periprocedural bleeding [ Time Frame: Day 30 ]
  2. Incidence of minor periprocedural bleeding [ Time Frame: Day 30 ]
  3. All cause mortality [ Time Frame: Day 30 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients undergoing radiofrequency catheter ablation for scar VT which includes VT secondary to ischemic cardiomyopathy and non-ischemic cardiomyopathy
  • Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test within 24 hours prior to the start of study drug
  • Women must not be breastfeeding
  • WOCBP must agree to follow instructions for method(s) of contraception for the duration of treatment with Apixaban plus 33 days post-treatment completion
  • Males who are sexually active with WOCBP must agree to follow instructions for method(s) of contraception for the duration of treatment and for a total of 93 days post-treatment completion
  • Participants must agree to the use of one approved method of contraception

Exclusion Criteria:

  • History of cerebral vascular accident/transient ischemic attack (CVA/TIA) in last 3 months
  • Cardiac surgery or neurosurgery within 3 months of the intended procedure date
  • Any active bleeding
  • Severe hypersensitivity reaction to ELIQUIS (including drug hypersensitivity, such as skin rash and allergic reactions)
  • Participants cannot have prosthetic heart valves
  • History or bleeding and clotting disorders
  • Contraindications to Aspirin therapy
  • Contraindication to oral anticoagulation
  • Patient on an anticoagulant prior to the ablation for other primary indications like atrial fibrillation (AF), deep vein thrombosis (DVT) or a mechanical valve
  • Evidence of intracardiac thrombus
  • Patient with Creatinine Clearance of < 30 cc/min
  • Participation in another investigational study related to oral anticoagulation, drug and/or device intervention
  • Claustrophobic patients
  • Implantable Cardioverter Defibrillator (ICD) generator placement before the year 2000
  • Has an ICD and is pacing dependent without underlying rhythm upon interrogation at baseline
  • Patient has abandoned leads
  • Patients who are on p-glycoprotein inducers or inhibitors where the dose of Apixaban cannot be effectively altered

Information from the National Library of Medicine

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


Locations
United States, Kansas
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
Sponsors and Collaborators
University of Kansas Medical Center
Bristol-Myers Squibb
Investigators
Principal Investigator: Dhanunjaya Lakkireddy, MD University of Kansas Medical Center

Responsible Party: University of Kansas Medical Center
ClinicalTrials.gov Identifier: NCT02666742     History of Changes
Other Study ID Numbers: STUDY00003241
CV185-415 ( Other Identifier: KUMC )
First Posted: January 28, 2016    Key Record Dates
Last Update Posted: May 23, 2018
Last Verified: May 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
Tachycardia
Tachycardia, Ventricular
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Aspirin
Apixaban
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics
Factor Xa Inhibitors
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Anticoagulants