First US Patients Enroll in Boehringer Ingelheim's Global RE-DUAL PCI and RE-CIRCUIT Trials Evaluating Pradaxa
Boehringer Ingelheim has announced that the first US patients have been enrolled in two of the company's international clinical trials, RE-DUAL PCI (NCT02164864) and RE-CIRCUIT (NCT02348723). RE-DUAL PCI will evaluate the efficacy and safety of Pradaxa (dabigatran etexilate mesylate) in patients with non-valvular atrial fibrillation (NVAF) who have undergone percutaneous coronary intervention (PCI), also known as angioplasty, with stent placement. RE-CIRCUIT will evaluate the safety of PRADAXA in NVAF patients undergoing a first ablation procedure, which is conducted to help prevent heart rhythm problems.
"Despite current strategies for reducing vascular risk factors in NVAF, there is still a need to decrease the risk of stroke in patients requiring anticoagulation during interventions such as PCI and ablation," said Sabine Luik, senior vice president, Medicine & Regulatory Affairs, Boehringer Ingelheim Pharmaceuticals, Inc. "The initiation of these two studies reinforces Boehringer Ingelheim's commitment to examining appropriate anticoagulation with Pradaxa to improve outcomes in patients undergoing these procedures."
Both trials are part of Boehringer Ingelheim's extensive RE-VOLUTION clinical trial program for Pradaxa. The program includes 14 studies and is expected to involve more than 50,000 patients in more than 44 countries globally. Pradaxa was initially approved by the FDA in 2010 to reduce the risk of stroke and systemic embolism in patients with NVAF. In 2014, the FDA approved two additional indications for Pradaxa for the treatment of DVT and PE in patients who have been treated with a parenteral anticoagulant for five to 10 days, and to reduce the risk of recurrent DVT and PE in patients who have been previously treated.
Related News
-
News BioNTech to begin mRNA vaccine manufacturing in Rwanda by 2025
German biotechnology company BioNTech has stated their intentions to begin production at their mRNA vaccine factory in Rwanda by 2025, which will mark the first foreign mRNA vaccine manufacturing site on the continent of Africa. -
News Identifying Alzheimer’s Disease biomarker proteins with whole blood tests
A University of Manchester spin-out pharmaceutical company, PharmaKure, has reported successful study results for the quantification of Alzheimer’s Disease biomarker proteins with a whole blood test. -
News Bill & Melinda Gates Foundation to boost mRNA vaccine initiatives in Africa with USD $40m
To address vaccine inequality and accessibility issues, the Bill & Melinda Gates Foundation aims to deliver USD $40m to various biotech companies and vaccine manufacturers in support of mRNA vaccine development. -
News CPHI Podcast Series: Exploring neurological frontiers in Alzheimer's and beyond
The next episode of the CPHI Podcast Series delves into the science and background behind some recent developments in the field of Alzheimer's disease and neurological disorders. -
News Is patient centricity the future of pharmaceutical manufacturing?
In this interview with Sandra Sánchez y Oldenhage, President of PharmAdvice, she speaks to the importance of considering patients in the manufacturing stages of the pharmaceutical supply chain, and how it can redefine healthcare. -
News CPHI Podcast Series: How to leverage AI for Drug Discovery
Artificial intelligence is the topic of debate in the latest episode from the CPHI Podcast Series, where Digital Editor Lucy Chard speaks with Bill Whitford of DPS Group about the integration of AI in healthcare. -
News Pfizer forges ahead with blood cancer therapy after approval from FDA
Pfizer gains accelerated approval from the US FDA for their new bispecific antibody therapy for multiple myeloma, set to address an unmet need for patients. -
News Alzheimer's drug donanemab deemed effective in landmark clinical trial
Results from the TRAILBLAZER-ALZ 2 Randomised Clinical Trial into the use of donanemab to treat early symptoms of Alzheimer’s disease have been analysed.
Position your company at the heart of the global Pharma industry with a CPHI Online membership
-
Your products and solutions visible to thousands of visitors within the largest Pharma marketplace
-
Generate high-quality, engaged leads for your business, all year round
-
Promote your business as the industry’s thought-leader by hosting your reports, brochures and videos within your profile
-
Your company’s profile boosted at all participating CPHI events
-
An easy-to-use platform with a detailed dashboard showing your leads and performance