Boehringer Ingelheim has planned to start two large, global clinical trials of Pradaxa (dabigatran etexilate) evaluating its efficacy and safety in stroke prevention therapy in two clinically highly relevant conditions.
The RE-SPECT ESUS trial will investigate the efficacy and safety of Pradaxa in patients whose first stroke was of embolic origin with unknown source (ESUS). Embolic strokes occur when a blood clot forms somewhere in the body and travels through the bloodstream to the brain.
The RE-DUAL PCI trial will 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 stenting.
Both the trials are scheduled to begin enrolment in mid-2014 and respectively, early 2015 and will form part of the extensive RE-VOLUTION clinical trial programme for Pradaxa, which will include 14 clinical trials involving over 55,000 patients in more than 44 countries globally when the two new trials are completed.
"Pradaxa was approved in 2010 to reduce the risk of stroke and systemic embolism in patients with atrial fibrillation, making it the first oral anticoagulant approved since warfarin was launched more than 50 years ago," said Professor Klaus Dugi, corporate senior vice president Medicine, Boehringer Ingelheim "These plans for new trials reflect our confidence in the future of Pradaxa and our belief in its potential to benefit patient populations with the greatest unmet needs. We are hopeful the results of the trials will provide greater understanding of Pradaxa’s potential to reduce the risk of stroke and other life-threatening events for these patients."
Higher rates of morbidity and mortality are seen in patients suffering a recurrent stroke after an ESUS. There is limited knowledge and data available to guide treatment decisions regarding secondary prevention of stroke in these patients, resulting in considerable unmet need.
The RE-SPECT ESUS trial (Randomized Evaluation in Secondary stroke Prevention Comparing the Thrombin inhibitor dabigatran etexilate versus ASA in Embolic Stroke of Undetermined Source) will be led by Professor Hans-Christoph Diener, professor of Neurology and chairman of the Department of Neurology, University of Essen, Germany. The trial aims to include 6,000 patients who had an ESUS within three months of enrolment.
Detailed plans include: evaluating Pradaxa compared to acetylsalicylic acid 100 mg once daily (the current standard of care) for reduction of recurrent stroke. The majority of patients will receive Pradaxa 150 mg twice daily. Patients aged 75 or older or who have moderate renal impairment (CrCl 30-50 mL/min) will receive Pradaxa 110 mg twice daily; treatments will be given for six months to three years, and major outcomes will be assessed up to 30 days after the end of treatment.
Research shows that patients with atrial fibrillation undergoing PCI with stenting are at high risk of stroke and other major adverse cardiac events, which can be reduced by anticoagulation therapy. Currently, about one in every 10 patients undergoing PCI with stenting requires anticoagulant therapy to reduce their risk of stroke due to either atrial fibrillation or other conditions.
The RE-DUAL PCI trial (Randomized Evaluation of Dual Therapy with Dabigatran vs. Triple Therapy Strategy with Warfarin in Patients with NVAF that have undergone PCI with Stenting) is planned to run in cooperation with Harvard Clinical Research Institute (HCRI), led by Professor Christopher Cannon, MD, cardiologist at Brigham and Women’s Hospital in Boston and Professor of Medicine at Harvard Medical School in the US.
Detailed plans include: event-driven trial will evaluate Pradaxa (150 mg or 110 mg twice daily) plus single antiplatelet therapy with a P2Y12 protein inhibitor, 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.
Boehringer Ingelheim is committed to expanding scientific knowledge in stroke prevention and interventional cardiology with Pradaxa - with an extensive and robust real-world experience of over 2 million patient years in all indications Pradaxa has already established a safety and efficacy profile that delivers meaningful clinical benefits to patients.
The Boehringer Ingelheim group is committed to researching, developing, manufacturing and marketing novel medications of high therapeutic value for human and veterinary medicine.