Veterinarians

enrollment

enrollment checklist

Recheck checklist

I have diagnosed a cat with an aortic thromboembolism (“saddle thrombus”), or other cardiogenic embolic disease. Can this cat be entered into the SUPERCAT study?

 — Yes! We would love to enroll this patient! In a nutshell, the SUPERCAT study is focused on studying the ability of two different anticoagulant medications (clopidogrel or rivaroxaban) to prevent recurrent thromboembolism caused by heart disease in cats. Animals that are enrolled will receive up to 2 years worth of one of these anticoagulant medications, and some funds to defray the costs of repeat examinations by a veterinary cardiologist. Cats that are eligible have experienced and recovered from a thromboembolism. Cats cannot receive other anticoagulant medications once they start the study drug.

What do I need to do to register this cat for the study?

 — In order to be enrolled in the study, the cat must undergo an echocardiographic evaluation by a board-certified cardiologist, and the owner must be prepared to bring the cat for at least 4 recheck visits to the cardiologist over 2 years (specifically at 2 months, 6 months, 12 months, and 18 months following enrollment). Board-certified veterinary cardiologists are listed at http://find.vetspecialists.com/

— The owner also must be willing and able to administer the study drug, a single oral pill, by mouth, once daily, for the duration of the study.

— In order to be enrolled, the cat must be recovering from the previous embolic event, and be eating reliably. He or she should not have signs of congestive heart failure, and should be receiving stable doses of cardiac medications (if appropriate) for at least 5 days prior to starting the study drug.

— To enroll a cat, please send an email to: supercatstudy@gmail.com. Please include the cat’s signalment, and whether or not he or she has been evaluated by a veterinary cardiologist. In addition, the owner’s name, address, email address, and phone number are required.   We will contact the owner to verify shipping preferences, and to answer any questions that they may have. In addition, they will be required to provide informed consent prior to entering the study.   Once enrolled, both you and the owner will be given access to a dedicated phone line that may be used to ask any questions about the study while it is ongoing. The owners will also fill out a questionnaire about the cat’s activity levels.

— If you are a veterinary cardiologist, we will also provide you with a summary sheet to document your echocardiographic findings.

Can I give the cat medications while I am waiting for the study drug?

— This study focuses on long term maintenance of cats with cardiogenic embolism, and specifically prevention of recurrence of embolism. To this end, the acute therapies (anticoagulants, diuretics, oxygen, etc) employed to treat the cat following initial presentation are not restricted, however, once the study drug is started, all anticoagulant therapies except for the study drug must be discontinued. Depending on the current regimen, we can discuss plans for a safe transition to the study drug.

What is expected of me for long-term maintenance of a cat on the study?

 –We expect that cats will continue to visit their family veterinarians for routine care, on these visits, specific attention to any areas of petechiation or bruising, in addition to cardiac auscultation and peripheral pulse palpation

 What are the endpoints of the study?

 — The primary endpoint is the time to recurrence of thromboembolism, as we anticipate that both of these drugs will significantly delay this occurrence. Secondary endpoints are the incidence of congestive heart failure and also the cause of death, if death occurs prior to the completion of the study.

How do I prescribe the study drug?

 –Upon enrollment of a cat into the study, we ask that a veterinarian who has examined the cat (either the primary care veterinarian or the cardiologist) write two prescriptions: one for rivaroxaban (2.5 mg PO, q.24h) and one for clopidogrel (18.75 mg PO, q. 24h). Once the study director is in receipt of the prescriptions, the cat will be randomized to receive one or the other, and only the appropriate prescription will be filled. This system will maintain some blinding, and allow appropriate randomization.

 Can I perform surgeries or oral health treatments on a cat that is taking a study drug?

–Maybe. There are specific guidelines in human medicine regarding the timeline for emergency or planned surgery for each study drug. Please contact us by phone or email if you are planning a surgery on a cat on the study.

I am a veterinary cardiologist; how will I communicate my echocardiograph result findings to you?

 — Once enrolled, you will receive a unique login for the website, which will allow you to fill out the echo parameters on a web-based form and submit the data easily

How will the clients receive the medication for their cat?

  The study medications will be shipped directly to the owner. The owners will be asked not to reveal the specific medication to the cardiologist performing the regular rechecks, but may share this information with their family veterinarian.

How will I know what drug a patient is receiving?

 — Due to various legal restrictions, we cannot perform this study in a double blinded manner, although medications will be randomized. Consequently, the owners will know the type of medication that their cat is receiving, and can reveal this to any veterinarian in case of emergency.

What will happen at the completion of the study?

 — At the end of 2 years, owners may elect to continue to administer the study medication, or can elect to pursue a different regimen. Because the rivaroxaban used in the study will be compounded by a commercial pharmacy, owners will have the opportunity to continue to purchase and receive rivaroxaban from this source.

Leave a Reply

Your email address will not be published. Required fields are marked *