Boehringer Ingelheim Pharmaceuticals plans to initiate two new global clinical trials of PRADAXA. One of the new trials, RE-DUAL PCI (Randomized Evaluation of Dual Therapy with Dabigatran v. Triple Therapy Strategy with Warfarin in Patients with NVAF that have undergone PCI with Stenting), is designed to evaluate the efficacy and safety of PRADAXA in patients with non-valvular atrial fibrillation (NVAF) who have undergone percutaneous coronary intervention (PCI), also known as angioplasty, with stent placement. The second of the new trials, RE-SPECT ESUS(TM) (Randomized Evaluation in Secondary stroke Prevention Comparing the Thrombin inhibitor dabigatran etexilate v. ASA in Embolic Stroke of Undetermined Source), is designed to evaluate the efficacy and safety of PRADAXA as a secondary stroke prevention therapy in patients who have suffered an embolic stroke of undetermined source (ESUS). Embolic strokes occur when a blood clot forms somewhere in the body and travels through the bloodstream to the brain.
Both trials would become part of the extensive RE-VOLUTION clinical trial program for PRADAXA, which includes 10 completed phase III clinical trials involving approximately 40,000 patients in more than 44 countries globally, and are planning to begin enrollment in 2014 and 2015, respectively.
"Despite current management options, many patients, including those who have already had a stroke and those with NVAF who are about to undergo PCI, continue to face a high stroke risk," said John Smith, M.D., Ph.D., senior vice president, Clinical Development and Medical Affairs, Boehringer Ingelheim. "BI is committed to advancing innovation and research in cardiovascular disease. We are hopeful that the results of the trials will provide greater understanding of PRADAXA's potential to reduce stroke risk in these patient populations."
RE-DUAL PCI is planned to be run cooperatively with Harvard Clinical Research Institute (HCRI) and led by Christopher Cannon, M.D., cardiologist at Brigham and Women's Hospital in Boston and professor of medicine at Harvard Medical School. This event-driven trial will evaluate PRADAXA (150mg or 110mg twice daily) plus single antiplatelet therapy compared to the current standard of care which includes warfarin and two antiplatelet agents, to assess key outcomes of clinically relevant bleeding and thrombotic events (defined as the combined rate of death, myocardial infarction and stroke) following PCI.
Research shows that patients with atrial fibrillation undergoing PCI with stent placement are at high risk of stroke and other major adverse cardiac events, which can be reduced by anticoagulation therapy. Currently, about one in every 20 patients undergoing PCI with stent placement requires anticoagulant therapy to reduce their risk of stroke due to either atrial fibrillation or another condition.
RE-SPECT ESUS is planned to be run by Professor Hans-Christoph Diener, professor of neurology and chairman of the department of neurology, University of Essen, Germany. The trial plans to include approximately 6,000 patients who had an ESUS within three months prior to enrollment. The trial will evaluate two doses of PRADAXA compared to acetylsalicylic acid 100mg once daily for secondary stroke prevention. Patients who are 75 years old or younger and who have normal kidney function will receive PRADAXA 150mg twice daily. Patients older than 75 or who have reduced renal function will receive PRADAXA 110mg twice daily. The treatment duration is planned to be six months to three years, with outcomes assessed up until 30 days after the end of treatment.
According to the American Heart Association, approximately 795,000 Americans each year suffer a stroke, with nearly one in four patients having already suffered a prior stroke. It is estimated that up to 14% of people who have a stroke will have another within one year.
"PRADAXA was approved in the U.S. in 2010 to reduce the risk of stroke and systemic embolism in patients with NVAF, making it the first oral anticoagulant approved since warfarin was launched for this use more than 50 years ago," said Sabine Luik, M.D., senior vice president, Medicine and Regulatory Affairs, U.S. regional medical director, Boehringer Ingelheim.
"These planned new trials reflect our confidence in the future of PRADAXA and our belief in its potential to benefit different patient populations."