• First exploratory study of a non-vitamin K antagonist oral anticoagulant (NOAC) in this population
• The study is part of Boehringer Ingelheim’s commitment to advancing thrombosis care
INGELHEIM, Germany-Wednesday 4 September 2019 [ AETOS Wire ]
Randomised evaluation of the safety and efficacy of dabigatran etexilate versus dose adjusted warfarin in patients with cerebral venous thrombosis (RE-SPECT CVT®)1
RE-SPECT CVT® was 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.1
(BUSINESS WIRE) -- Boehringer Ingelheim today 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.
The
results provide 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.1
“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 the
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
furthers the understanding of the safety profile of dabigatran, which
has been documented in the extensive RE-VOLUTION® trial and registry programme.2-24
About the RE-SPECT CVT® study
Randomised evaluation of the safety and efficacy of dabigatran etexilate versus dose adjusted warfarin in patients with cerebral venous thrombosis (RE-SPECT CVT®)1
RE-SPECT CVT® was 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.1
Please click on the following link for ‘Notes to Editors’ and ‘References’: http://www.boehringer-ingelheim.com/press-release/re-spect-cvt-study-data-published
Intended audiences:
This press release is issued from our Corporate Headquarters in Ingelheim, Germany and is intended to provide information about our global business. It is directed to the international audience outside Germany. Please be aware that information relating to the approval status and labels of approved products may vary from country to country, and a country-specific press release on this topic may have been issued in the countries where we do business.
This press release is issued from our Corporate Headquarters in Ingelheim, Germany and is intended to provide information about our global business. It is directed to the international audience outside Germany. Please be aware that information relating to the approval status and labels of approved products may vary from country to country, and a country-specific press release on this topic may have been issued in the countries where we do business.
View source version on businesswire.com: https://www.businesswire.com/news/home/20190903005991/en/
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55216 Ingelheim/Germany
Phone: +49 6132 77 182085
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Fax: +49 6132 77 6601
Email: press@boehringer-ingelheim.com
