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

News | Antiplatelet and Anticoagulation Therapies

November 17, 2021 — Taking daily low-dose aspirin for seven years did not affect the risk of dementia or mental decline ...

Home November 17, 2021
Home
News | Antiplatelet and Anticoagulation Therapies

November 9, 2021 — Utilizing a magnetically-controlled capsule endoscopy system, the double-blind, randomized OPT-PEACE ...

Home November 09, 2021
Home
News | Antiplatelet and Anticoagulation Therapies
October 4, 2021 — One month of dual antiplatelet therapy (DAPT) following stent implantation in high bleeding risk ...
Home October 04, 2021
Home
News | Antiplatelet and Anticoagulation Therapies

September 1, 2021 — The STOPDAPT-2 ACS trial does not support the use of one month of dual antiplatelet therapy (DAPT) ...

Home September 01, 2021
Home
News | Antiplatelet and Anticoagulation Therapies

September 1, 2021 – The anticoagulant edoxaban (Savaysa) may be just as effective as warfarin for preventing heart ...

Home September 01, 2021
Home
News | Antiplatelet and Anticoagulation Therapies

June 21, 2021 — The U.S. Food and Drug Administration (FDA) approved Boehringer Ingelheim's dabigatran etexilate ...

Home June 21, 2021
Home
News | Antiplatelet and Anticoagulation Therapies

May 15, 2021 — The ADAPTABLE trial found no significant differences in cardiovascular events or major bleeding in ...

Home May 15, 2021
Home
News | Antiplatelet and Anticoagulation Therapies

April 28, 2021 — An analysis of the prospective Chinese Fuwai PCI Registry, confirms long-term, dual-antiplatelet ...

Home April 28, 2021
Home
Feature | Antiplatelet and Anticoagulation Therapies | By Dave Fornell, Editor

A comprehensive review or more than 80 randomized controlled trials (RCTs) investigating how to best manage optimal ...

Home March 22, 2021
Home
Videos | Antiplatelet and Anticoagulation Therapies

The COMPARE CRUSH Trial looked at the effect of per-hospital crushed prasugrel tablets in patients with STEMI planned ...

Home October 19, 2020
Home
Subscribe Now