INGELHEIM, Germany - Tuesday, August 19th 2014 [ME NewsWire]
Worldwide RE-DUAL PCITM to enroll up to 8,500 patients with atrial fibrillation who have received a coronary stent1
Data intended to help understand how to reduce blood clot risk and minimise bleeding risk in this patient population
Study is cooperatively conducted by the Harvard Clinical Research Institute and Boehringer Ingelheim
For Non-US/Non-UK/Non-Canadian Media
Boehringer Ingelheim today announces that the first patients have been enrolled in the company’s new international phase III study, RE-DUAL PCITM.1 The study will evaluate the efficacy and safety of the oral anticoagulant dabigatran etexilate in patients with an irregular heartbeat called non-valvular atrial fibrillation (AF), who have undergone a percutaneous coronary intervention (PCI) with stent placement to widen their blocked coronary arteries.2 RE-DUAL PCITM aims to advance medical knowledge and guide future antithrombotic treatment choice for greatest patient benefit. It addresses the need for innovative new treatment regimens to improve patient prognosis.
AF is associated with a risk of stroke caused by blood clots from the heart.3 PCI, also known as angioplasty, is a medical procedure where a stent (a small mesh tube) is used to widen the arteries of the heart to restore or improve blood flow in patients with coronary artery disease.4 However the procedure is also associated with a risk of serious complications caused by blood clots, including stroke and other major adverse cardiac events.5,6 Patients with AF who undergo PCI are thus at special risk of these complications. To prevent them, patients receive antithrombotic therapy. Current standard care is linked to an increased risk of bleeding, because it currently involves taking three antithrombotic treatments together, one of them an anticoagulant.7
“Currently there are limited data about appropriate anticoagulation treatment in patients with AF undergoing PCI,” said Professor Christopher Cannon, RE-DUAL PCITM Lead Investigator and Executive Director, Cardiometabolic Trials, Harvard Clinical Research Institute. “We expect this study to provide data that can help us better understand how to prevent stroke and stent thrombosis while at the same time minimising bleeding risk in this especially vulnerable patient population,” said Cannon, who also is a cardiologist at Brigham and Women’s Hospital in Boston and a Professor of Medicine, Harvard Medical School.
The RE-DUAL PCITM study will compare the efficacy and safety of dual antithrombotic therapy with dabigatran etexilate (110mg or 150mg twice daily) plus clopidogrel or ticagrelor versus the currently recommended standard triple antithrombotic therapy regimen with warfarin (INR 2.0 – 3.0) plus clopidogrel or ticagrelor plus acetylsalicylic acid.2 The study will enroll approximately 8,500 patients at 700 sites in over 40 countries around the globe.1 Boehringer Ingelheim is conducting the study cooperatively with the Harvard Clinical Research Institute.
“Boehringer Ingelheim is confident in the ability of dabigatran etexilate to safely reduce the risk of thromboembolic events when used as directed and is committed to expanding the scientific knowledge of dabigatran use in AF patients who undergo significant procedures for their cardiac conditions,” said Professor Klaus Dugi, Chief Medical Officer, Boehringer Ingelheim. “We look forward to the continuing enrollment of patients in RE-DUAL PCITM and expect to have full results in 2017.”
RE-DUAL PCITM is part of Boehringer Ingelheim’s extensive clinical trial program, RE-VOLUTIONTM. With the recently announced RE-CIRCUITTM and RE-SPECT ESUSTM studies, the entire programme will include 15 clinical trials involving over 60,000 patients in more than 100 countries globally.2,8-20
Please click on the link below for ‘Notes to Editors’ and ‘References’: http://www.boehringer-ingelheim.com/news/news_releases/press_releases/2014/19_august_2014_dabigatranetexilate.html
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