Drug Discovery and Development

  • Home Drug Discovery and Development
  • Drug Discovery
  • Women in Pharma and Biotech
  • Oncology
  • Neurological Disease
  • Infectious Disease
  • Resources
    • Video features
    • Podcast
    • Voices
    • Webinars
  • Pharma 50
    • 2025 Pharma 50
    • 2024 Pharma 50
    • 2023 Pharma 50
    • 2022 Pharma 50
    • 2021 Pharma 50
  • Advertise
  • SUBSCRIBE

Xarelto Study Stopping Early After Meeting Primary Endpoint

By Janssen Research & Development, LLC | February 9, 2017

Phase 3 COMPASS study of Xarelto (rivaroxaban) stopping early for efficacy; study meets primary endpoint of prevention of major adverse cardiac events in patients with coronary artery disease or peripheral artery disease.

Janssen Research & Development, LLC announced that the Phase 3 COMPASS trial, 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), is stopping earlier than planned. 

The decision 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, 2018i. 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.

“Despite established and effective treatments, incidences of CAD and PAD are rising globally,” said Paul Burton, M.D., Ph.D., FACC, vice president, medical affairs, Janssen. “We are excited about the possibility of making rivaroxaban available to patients with CAD and PAD to reduce their risk of major adverse cardiac events, and look forward to discussing the COMPASS trial data with the U.S. Food and Drug Administration as quickly as possible.”

CAD affects 16.5 million Americansii. PAD affects more than 10 million Americansiii, and is a powerful risk marker of cardiovascular disease. Globally, screening studies suggest approximately 20 percent of adults older than 55 years have evidence of PADiv.
__________________________________________________

References:

i https://clinicaltrials.gov/ct2/show/NCT01776424

ii Circulation. 2017; CIR.0000000000000485;ii AHA Statistical Update, Heart Disease and Stroke Statistics—2017 Update: A Report From the American Heart Association, Originally published January 25, 2017, page 360, downloaded from https://circ.ahajournals.org/content/early/2017/01/25/CIR.0000000000000485

iii Circulation. 2017;CIR.0000000000000485; AHA Statistical Update, Heart Disease and Stroke Statistics—2017 Update: A Report From the American Heart Association, Originally published January 25, 2017, page 408, downloaded from https://circ.ahajournals.org/content/early/2017/01/25/CIR.0000000000000485

iv Hankey GJ, Norman PE, Eikelboom JW. Medical Treatment of Peripheral Arterial Disease. JAMA. 2006;295(5):547-553

(Source: PR Newswire)


Filed Under: Drug Discovery

 

Related Articles Read More >

Sanders, King target DTC pharma ads but the industry worries more about threats to its $2B R&D model
Zoliflodacin wins FDA nod for treatment of gonorrhea
FDA approved ENFLONSIA for the prevention of RSV in Infants
First clinical study results of Dupixent for atopic dermatitis in patients with darker skin tones 
“ddd
EXPAND YOUR KNOWLEDGE AND STAY CONNECTED
Get the latest news and trends happening now in the drug discovery and development industry.

MEDTECH 100 INDEX

Medtech 100 logo
Market Summary > Current Price
The MedTech 100 is a financial index calculated using the BIG100 companies covered in Medical Design and Outsourcing.
Drug Discovery and Development
  • MassDevice
  • DeviceTalks
  • Medtech100 Index
  • Medical Design Sourcing
  • Medical Design & Outsourcing
  • Medical Tubing + Extrusion
  • Subscribe to our E-Newsletter
  • Contact Us
  • About Us
  • R&D World
  • Drug Delivery Business News
  • Pharmaceutical Processing World

Copyright © 2025 WTWH Media LLC. All Rights Reserved. The material on this site may not be reproduced, distributed, transmitted, cached or otherwise used, except with the prior written permission of WTWH Media
Privacy Policy | Advertising | About Us

Search Drug Discovery & Development

  • Home Drug Discovery and Development
  • Drug Discovery
  • Women in Pharma and Biotech
  • Oncology
  • Neurological Disease
  • Infectious Disease
  • Resources
    • Video features
    • Podcast
    • Voices
    • Webinars
  • Pharma 50
    • 2025 Pharma 50
    • 2024 Pharma 50
    • 2023 Pharma 50
    • 2022 Pharma 50
    • 2021 Pharma 50
  • Advertise
  • SUBSCRIBE