News | October 31, 2013

Abbott’s U.S. Clinical Trial to Evaluate Three-Month Duration for Anti-Clotting Medications with its Xience Drug Eluting Stent System

xience prime xpedition V antiplatelet stents eluting clinical trial study cath
October 31, 2013 — Abbott announced it plans to initiate a randomized, controlled trial in the United States to evaluate the use of dual anti-platelet therapy (DAPT) for a three-month duration following treatment with the company's Xience family of drug eluting stents (DES)
 
The trial is designed to support regulatory filings to update the product labeling for Abbott's Xience family of DES in the United States, where dual anti-platelet therapy duration is currently recommended for a minimum of 12 months after treatment with a drug eluting stent. Mitch Krucoff, M.D., professor of Medicine and Cardiology, Duke University Medical Center, director, Cardiovascular Devices Unit and director, eECG Core Laboratory, Duke Clinical Research Institute, Durham, N.C., and Roxanna Mehran, M.D., professor of Medicine, Evidence and Health Policy, Icahn School of Medicine and director, Interventional Cardiovascular Research and Clinical Trials, Mount Sinai School of Medicine, New York are the primary investigators for the trial. 
 
"The appropriate duration of DAPT following treatment with a drug eluting stent is one of the most important and highly debated topics among cardiologists," said Krucoff. "Prolonged use of DAPT can be associated with issues such as bleeding complications, patient non-compliance and increased cost, and it is not clear that it is associated with a marked safety benefit. Abbott's leadership in embarking on this clinical trial is an important step in addressing a key question about optimizing therapy with drug eluting stents."
 
The trial will randomize more than 4,000 patients to either a three-month or a 12-month DAPT regimen following implantation with a Xience drug eluting stent. Patients will be blinded to which regimen they are taking. The primary endpoint of the trial will be the difference in the rate of major adverse cerebral and cardiovascular events (MACCE).
 
"Patients often struggle with taking blood thinners for a year or more following implantation of their stent," said Mehran. "This randomized trial will provide the highest level of clinical evidence to inform physicians about the appropriate duration of dual anti-platelet therapy for patients in the U.S. treated with the Xience family of drug eluting stents."
 
Xience Xpedition is available in the United States, Japan, Europe, the Middle East and parts of Asia. Xience Prime and Xience V are available in countries throughout the world.
 
For more information: www.abbott.com
 

Related Content

The first 3-D images have been created of an RNA molecule known as "Braveheart" for its role in transforming stem cells into heart cells. Credit: Image courtesy Los Alamos National Laboratory

The first 3-D images have been created of an RNA molecule known as "Braveheart" for its role in transforming stem cells into heart cells. Credit: Image courtesy Los Alamos National Laboratory

News | Cardiovascular Clinical Studies | January 20, 2020
January 20, 2020 — Scientists at Los Alamos and international partners have created the first 3-D images of a special
Top Cardiology New in 2019 From the European Society of Cardioloigy (ESC)
News | Cardiovascular Clinical Studies | December 23, 2019
Environmental and lifestyle issues were popular this year, with pick up from both...
News | Cardiovascular Clinical Studies | November 26, 2019
November 26, 2019 — The University of Connecticut (UConn) Department of Kinesiology and Hartford Healthcare have sele
FDA Issues Final Guidance on Live Case Presentations During IDE Clinical Trials
News | Cardiovascular Clinical Studies | July 10, 2019
The U.S. Food and Drug Administration (FDA) issued the final guidance “Live Case Presentations During Investigational...
Veradigm Partners With American College of Cardiology on Next-generation Research Registries
News | Cardiovascular Clinical Studies | July 03, 2019
The American College of Cardiology (ACC) has partnered with Veradigm, an Allscripts business unit, to power the next...
New FDA Proposed Rule Alters Informed Consent for Clinical Studies
News | Cardiovascular Clinical Studies | November 19, 2018
The U.S. Food and Drug Administration (FDA) is proposing to add an exception to informed consent requirements for...
A key slide from Elnabawi's presentation, showing cardiac CT plaque evaluations, showing the impact of psoriasis medication on coronary plaques at baseline and one year of treatment. It shows a reversal of vulnerable plaque development. #SCAI, #SCAI2018

A key slide from Elnabawi's presentation, showing cardiac CT plaque evaluations, showing the impact of psoriasis medication on coronary plaques at baseline and one year of treatment. It shows a reversal of vulnerable plaque development.  

Feature | Cardiovascular Clinical Studies | May 14, 2018
May 14, 2018 – New clinical evidance shows common therapy options for psoriasis (PSO), a chronic inflammatory skin di
Intravenous Drug Use is Causing Rise in Heart Valve Infections, Healthcare Costs. #SCAI, #SCAI2018
News | Cardiovascular Clinical Studies | May 14, 2018
May 14, 2018 — The opioid drug epidemic is impacting cardiology, with a new study finding the number of patients hosp
Patient Enrollment Completed in U.S. IDE Study of THERMOCOOL SMARTTOUCH SF Catheter
News | Cardiovascular Clinical Studies | March 15, 2018
March 15, 2018 –  Johnson & Johnson Medical Devices Companies announced today that Biosense Webster, Inc., who wo