Boehringer Ingelheim has announced the publication of primary analysis from RE-SPECT CVT, the first exploratory, prospective, randomised controlled study of a NOAC in patients with blood clots in the veins or venous sinuses of the brain. The trial investigated the safety and efficacy of Pradaxa (dabigatran etexilate) and dose-adjusted warfarin in patients with CVT.
RE-SPECT CVT is a prospective, randomised exploratory study assessing the safety and efficacy of dabigatran etexilate and warfarin in patients who suffer from CVT. The open-label study involved 120 patients from nine countries and looked to evaluate the suitability of dabigatran etexilate and warfarin for the treatment and secondary prevention of blood clots in the veins or venous sinuses of the brain. Patients aged ≥ 18 years old with a confirmed diagnosis of CVT (with or without haemorrhagic stroke) were randomised to receive either warfarin or dabigatran etexilate.
According to a statement, the results provide an insight into the role of anticoagulation in patients with CVT of mild-moderate severity. In the study, there were no recurrent venous thromboembolism (VTE) events in either treatment group. The trial also found that the rate of bleeding was low, with two patients in the warfarin arm (3.3%) and one (1.7%) in the dabigatran arm developing a major bleed. There was no mortality in either treatment arm in this study.
“Cerebral venous thrombosis, CVT, which affects predominantly young patients and women, can cause death and disability. Patients who survive the acute phase of CVT may suffer recurrent venous thrombosis. To prevent that, the usual clinical practice is to prescribe vitamin K antagonists (VKAs, such as warfarin). VKAs present limitations in terms of safety, dosing, reversibility and patient preference,” said Professor José M. Ferro, director of the Department of Neurosciences and Mental Health at Hospital Santa Maria in Lisbon, Portugal, and chair of the RE-SPECT CVT Steering Committee.
“RE-SPECT CVT was the largest trial performed in patients with CVT to date, enrolling 120 patients. The trial showed that the risk of recurrent VTE in CVT patients of mild to moderate severity under anticoagulant therapy with dabigatran for six months was low and associated with few major or clinically relevant bleeding events.”
The trial forms part of Boehringer Ingelheim’s ongoing commitment to expanding scientific knowledge of thrombosis care. Additionally, it aims to further the understanding of the safety profile of dabigatran, which has been documented in the extensive RE-VOLUTION trial and registry programme.