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.
