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Main » 2016 » May » 12 » Pradaxa®: First NOAC to be assessed in prospective study in patients with blood clots in the veins or venous sinuses of the brain
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Pradaxa®: First NOAC to be assessed in prospective study in patients with blood clots in the veins or venous sinuses of the brain

INGELHEIM, Germany - Wednesday, May 11th 2016 [ME NewsWire]

  -  RE-SPECT CVT® is a Phase III study of dabigatran etexilate (Pradaxa®) vs. warfarin in patients with cerebral venous thrombosis (CVT)1
  -  Results will assist physicians in selecting an appropriate oral anticoagulant for acute treatment and secondary prevention of blood clots in the veins or venous sinuses of the brain1

(BUSINESS WIRE)-- Boehringer Ingelheim will undertake the first prospective, randomised controlled study of a non-vitamin K antagonist oral anticoagulant (NOAC) in patients with blood clots in the veins or venous sinuses of the brain. RE-SPECT CVT® will investigate the safety and efficacy of dabigatran etexilate (Pradaxa®) compared to warfarin for acute treatment and secondary prevention of cerebral venous thrombosis (CVT). The new study was announced at the 2nd European Stroke Organisation Conference 2016 in Barcelona, Spain.1

Cerebral venous thrombosis (CVT) occurs when a blood clot forms in the brain’s veins or venous sinuses, the channels that drain blood from the brain. If these veins or channels become blocked, blood is unable to leave the brain. This can lead to an increase in intracranial blood pressure, congestion and leakage of blood into the brain tissues, which can eventually lead to a haemorrhagic stroke.2

Although relatively rare, CVT requires immediate medical attention and can lead to serious long term complications.2 Standard therapy for acute CVT treatment and secondary prevention of recurrent blood clots currently involves anticoagulation with unfractionated or low-molecular-weight heparin, followed by a vitamin K antagonist (VKA - warfarin).1 Dabigatran etexilate has already been shown to be effective in the treatment and prevention of other types of blood clots with a favourable safety profile compared to VKA therapy.3-7 RE-SPECT CVT® will investigate whether dabigatran etexilate also provides treatment advantages to patients with CVT.1

“We are very excited about this new study. Patients with CVT need effective treatment and we believe that they can benefit from recent advances in anticoagulation care,” advised Prof. José M. Ferro, Department of Neurosciences and Mental Health, Hospital Santa Maria, Lisbon, Portugal. “The RE-SPECT CVT® study will provide physicians with additional knowledge to address unmet medical need in this indication.”

The RE-SPECT CVT® study is the latest part of Boehringer Ingelheim’s innovation in anticoagulation care for patients and physicians. Boehringer Ingelheim launched dabigatran etexilate, the first NOAC for stroke prevention in patients with atrial fibrillation,8 and in 2015 gained approval for idarucizumab, the first and only specific NOAC reversal agent to be approved for use in emergency situations when immediate reversal of the anticoagulant effect of dabigatran is required.9

This press release is issued from our Corporate Headquarters in Ingelheim, Germany and is intended to provide information about our global business. 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.


Please click on the link below for ‘Notes to Editors and References’:



Boehringer Ingelheim GmbH

Friederike Middeke

Phone: +49 6132 – 77 141575

Fax: +49 6132 – 77 6601

E-mail: press@boehringer-ingelheim.com

Twitter: http://twitter.com/Boehringer


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