Phase 3 Study Results Show Xarelto Bests Aspirin With Fewer Blood Clots in Children


Rivaroxaban (Xarelto, Janssen) demonstrates a lower incidence of bleeding events in pediatric patients.

Rivaroxaban (Xarelto, Janssen), as an oral suspension, is associated with fewer blood clots and clinical events associated with blood clots in children aged 2 to 8 years following a Fontan procedure compared with treatment with aspirin, The Janssen Pharmaceutical Companies of Johnson & Johnson said in a statement.

“For years, health care providers have had limited options to help reduce potentially fatal thrombotic events that often occur in young children following the Fontan procedure,” Brian McCrindle, MD, MPH, pediatric cardiologist at the Hospital for Sick Children in Toronto, said in the statement. “We now not only have data suggesting that rivaroxaban has a similar positive effect and safety as aspirin, but we also have identified an age-appropriate formulation with precise weight-based dosing to help manage our young patients during a critical time.”

The phase 3 UNIVERSE study determined the comparative efficacy and safety profile of rivaroxaban and aspirin to be used for pediatric patients.

Study results showed that there was a comparable and low prevalence of bleeding events with rivaroxaban compared with aspirin. Non-major clinically relevant bleeding for the rivaroxaban group was at 6% compared with 9% for aspirin. Trivial bleeding was at 33% and 35%, respectively.

Rivaroxaban also had fewer thrombotic events, for an overall rate of 3% compared with an overall rate of 9% for the aspirin group.

The study was split into 2 parts. Part A was evaluated the pharmacodynamic and properties, while part B evaluated the efficacy and safety of rivaroxaban compared with aspirin.

During the first part, blood samples were collected on day 1 and 4 to determine if the individual could continue receiving rivaroxaban for the 12-month study period.

During the second part, individuals were randomized to receive either the body weight-adjusted rivaroxaban twice a day or aspirin, given once daily.

Results of the phase 3 UNIVERSE study were published in the Journal of the American Heart Association.


New phase 3 data suggest positive effect and show similar safety with XARELTO (rivaroxaban) compared to aspirin in pediatric Fontana procedure patients at risk for blood clots and blood clot-related events. Johnson & Johnson. News release. September 27, 2021. Accessed September 28, 2021.

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