Study Start Date: 05/15/16
Study End Date: 12/31/2022

Study of the Utility of Rivaroxaban or Clopidogrel for prevention of recurrent Arterial Thromboembolism in cats (SUPERCAT).

The SUPER-CAT trial compares clopidogrel to the new oral anticoagulant rivaroxaban in cats that have been diagnosed with and recovered from a cardiogenic thromboembolism (ie. a blood clot that had formed secondary to heart disease). The use of anticoagulant medication may improve survival and delay recurrence of blood clots in cats that are predisposed to clot formation. It is unclear if the mechanism in clot formation in cats with heart disease is a platelet-mediated or a coagulation factor mediated process. This study is designed to study the effects of clopidogrel — an antiplatelet drug — compared with rivaroxaban — an anticoagulant drug — with regards to prevention of the formation of another thromboembolism (clot). Cats will be randomly assigned to receive one drug or the other, and will receive this drug free for 2 years. The study also provides a stipend to offset the cost of regular visits to a veterinary cardiologist.

Study Design:
This is a double blinded randomized active control study between clopidogrel and rivaroxaban.

Sample Size:
90 cats

Inclusion Criteria:

• Any cat that has had and survived a cardiogenic embolism.
• The presence of cardiac disease that could result in a cardiogenic embolism must be determined by a board-certified veterinary cardiologist and the values from the echocardiogram entered on the study web-based spreadsheet.
• Cats must be discharged from the hospital no longer in congestive heart failure (if previously present)
• Owners must be willing to
  1. administer once-daily study medication
  2. bring the cat back to the cardiologist for echocardiographic assessment at 2, 6, 12, and 18 months following admission to the study
  3. periodically fill out an activity questionnaire online.

Exclusion Criteria:

• Mobile intracardiac thrombus
• Clinical evidence of bleeding or coagulopathy
• Co-morbid diseases that require chronic treatment (with the exception of cardiac medications)
• Chronic therapy with medications that may alter the coagulation status (eg. corticosteroids)
• Inability to discharge from the hospital after initial thromboembolic episode.
• If the cat is diagnosed as hyperthyroid at the time of cardiogenic embolism and the cardiologist believes that the cause of the embolism may be thyrotoxic cardiomyopathy this cat is not eligible. If there is a cat with a prior diagnosis of hyperthyroidism that is receiving medication and subsequently develops a cardiogenic embolism (ie. heart disease not likely related to hyperthyroidism), this cat may be included.
• Owner unwilling to administer medication, answer web-based questionnaire, or to bring cat back to a cardiologist for rechecks.

Study Controls:
Cats in the clopidogrel arm of the study are the control group.

Study Endpoints:
Primary endpoint is recurrence of cardiogenic thromboembolism. Secondary endpoints are death from any cause

Samples:
Cats will be required to visit a board-certified veterinary cardiologist at 2, 6, 12, and 18 months after enrollment. At these visits, a small (2 mL) blood sample will be obtained to measure plasma drug concentrations. Samples are shipped frozen, overnight, to the University of Georgia using a prepaid fed ex account.

Study Website:
http://cvccr.com/

Costs/Reimbursements

• Study drug is provided free for 2 years.
• Participants (clients) receive $150 for each echocardiogram visit to defray the cost of each echocardiogram at 2, 6, 12, and 18 months.
• Shipping of samples from examining cardiologists is paid for by the study.

Full Disclosure information:
The study is funded by a grant from Morris Animal Foundation.
The investigator does not have a conflict of interest.
The study will be published if results are negative.
The study will be reported on VIN.
The authors will acknowledge VIN if the study is published.