News | Antiplatelet and Anticoagulation Therapies | February 09, 2017

Rivaroxaban Shows Superiority Over Aspirin in Patients With Coronary and Peripheral Artery Disease

COMPASS Study ended early because of it reached pre-specified criteria for superiority

Xarelto, rivaroxaban, COMPASS study, ends early,

February 9, 2017 — Janssen Research & Development LLC (Janssen) announced that the Phase 3 COMPASS trial is stopping earlier than planned. The trial was evaluating the efficacy and safety of Xarelto (rivaroxaban) for the prevention of major adverse cardiac events (MACE), including cardiovascular death, myocardial infarction and stroke in patients with coronary artery disease (CAD) or with peripheral artery disease (PAD). The decision to stop the trial is based on the recommendation of the study's independent Data Monitoring Committee (DMC), as the primary MACE endpoint has reached its pre-specified criteria for superiority.

The estimated study completion date for the COMPASS trial had been March 2018. Given the magnitude of effect, Janssen, Bayer and the Population Health Research Institute (PHRI), which collaborated on the COMPASS clinical trial, will offer rivaroxaban to study participants in an open-label extension trial.

The COMPASS trial evaluated Xarelto in patients with CAD or PAD. It enrolled 27,402 patients from more than 600 sites across more than 30 countries worldwide. In the study, patients were randomized to receive either rivaroxaban 2.5 mg twice daily in addition to aspirin 100 mg once daily, rivaroxaban 5 mg twice daily alone, or aspirin 100 mg once daily alone.

A complete analysis of the data from the COMPASS trial is expected to be presented at a medical meeting in 2017.

Xarelto is a prescription medicine used to reduce the risk of stroke and blood clots in people with atrial fibrillation, not caused by a heart valve problem. For patients currently well managed on warfarin, there is limited information on how Xarelto and warfarin compare in reducing the risk of stroke.

Xarelto is also a prescription medicine used to treat deep vein thrombosis and pulmonary embolism, and to help reduce the risk of these conditions occurring again.

It can also be prescribed to reduce the risk of forming a blood clot in the legs and lungs of people who have just had knee or hip replacement surgery.

Read the article “Advantages and Disadvantages of Novel Oral Anticoagulants.”

Read the article “Questions Remain on DAPT Prolongation.“

For more information: www.janssen.com

Related Content

Naveen Pereira, M.D., co-principal investigator of the TAILOR-PCI study, explaining the conclusions of the late-breaking trial data during the virtual ACC20 meeting. #ACC20 #ACC2020

Naveen Pereira, M.D., co-principal investigator of the TAILOR-PCI study, explaining the conclusions of the late-breaking trial data during the virtual ACC20 meeting. 

News | Antiplatelet and Anticoagulation Therapies | March 28, 2020
March 28, 2020 — The TAILOR-PCI trial that used genetic testing to guide which antiplatelet medication was given to p
The U.S. Food and Drug Administration (FDA) has approved two applications for the first generics of the anticoagulant Eliquis (apixaban).

The U.S. Food and Drug Administration (FDA) has approved two applications for the first generics of the anticoagulant Eliquis (apixaban).

Feature | Antiplatelet and Anticoagulation Therapies | December 27, 2019
December 27, 2019 — The U.S.
aspirin bottle
News | Antiplatelet and Anticoagulation Therapies | December 12, 2019
December 12, 2019 — Low-dose aspirin was not associated with a reduced risk of a fatal heart attack among African Ame
Videos | Antiplatelet and Anticoagulation Therapies | October 11, 2019
Ajay J. Kirtane, M.D., associate professor of medicine at Columbia University Irving Medical Center and director of the...
Videos | Antiplatelet and Anticoagulation Therapies | October 08, 2019
American Heart Association President Robert Harrington, M.D., explains the reasons for shorter duration dual-...
Three-Month DAPT Post-PCI Demonstrates Low Adverse Event Rate in High-Bleeding Risk Patients
News | Antiplatelet and Anticoagulation Therapies | September 30, 2019
Data from the EVOLVE Short DAPT study found that shortened three-month dual antiplatelet therapy (DAPT) did not...
Brilinta Monotherapy Reduces Clinically Relevant Bleeding Risk Post-PCI in High-Risk Patients
News | Antiplatelet and Anticoagulation Therapies | September 26, 2019
New data from the Phase IV independent TWILIGHT trial showed Brilinta (ticagrelor) monotherapy reduced the risk of BARC...