A Clinical Trial Comparing Efficacy and Safety of Dabigatran Etexilate With Warfarin in Patients With Cerebral Venous and Dural Sinus Thrombosis (RE-SPECT CVT)
NCT ID: NCT02913326
Last Updated: 2019-08-15
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
120 participants
INTERVENTIONAL
2016-12-13
2018-06-22
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Dabigatran etexilate
Dabigatran etexilate
Warfarin
Warfarin
Interventions
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Dabigatran etexilate
Warfarin
Eligibility Criteria
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Inclusion Criteria
* Confirmed diagnosis of Cerebral Venous or dural sinus thrombosis (CVT), with or without intracranial haemorrhage
* Completion of anticoagulation therapy for 5-15 days which has been administered until randomisation; anticoagulation must include full-dose low molecular weight heparin or unfractionated heparin
* Eligibility for treatment with an oral anticoagulant
Exclusion Criteria
* Planned surgical treatment for CVT
* Conditions associated with increased risk of bleeding
* History of symptomatic non-traumatic intracranial haemorrhage with risk of recurrence according to Investigator judgment
* Treatment with an antithrombotic regimen for an indication other than CVT and requiring continuation of that treatment for the original diagnosis without change in the regimen
* Severe renal impairment
* Active liver disease
* Pregnancy, nursing or planning to become pregnant while in the trial
18 Years
78 Years
ALL
No
Sponsors
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Boehringer Ingelheim
INDUSTRY
Responsible Party
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Principal Investigators
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Boehringer Ingelheim
Role: STUDY_CHAIR
Boehringer Ingelheim
Locations
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HOP Pellegrin
Bordeaux, , France
HOP Lariboisière
Paris, , France
Vivantes Netzwerk für Gesundheit GmbH
Berlin, , Germany
Universitätsklinikum Essen AöR
Essen, , Germany
Asklepios Klinik Wandsbek
Hamburg, , Germany
Universitätsklinikum Heidelberg
Heidelberg, , Germany
Universitätsklinikum Tübingen
Tübingen, , Germany
Mazumdar Shaw Medical centre
Bangalore, , India
Nizam's Institute of Medical Sciences
Hyderabad, , India
Caritas Hospital
Kottayam, , India
Magnum Heart Institute
Nashik, , India
All India Institute of Medical Sciences
New Delhi, , India
Sahyadri Speciality Hospital
Pune, , India
ASST di Cremona
Cremona, , Italy
Fondazione Centro San Raffaele del Monte Tabor
Milan, , Italy
Nuovo Ospedale Civile S. Agostino-Estense
Modena, , Italy
A.O. San Camillo Forlanini
Roma, , Italy
Umberto I Pol. di Roma-Università di Roma La Sapienza
Roma, , Italy
A. O. Ospedale Circolo Fond. Macchi
Varese, , Italy
Academisch Medisch Centrum (AMC)
Amsterdam, , Netherlands
Universitair Medisch Centrum Utrecht
Utrecht, , Netherlands
University Clinical Center, Gdansk
Gdansk, , Poland
Copernicus Med.Company.Ltd,Hosp.Nicolaus, Gdansk
Gdansk, , Poland
Independent Public Clin.Hospital No.4,Neurol.Dept,Lublin
Lublin, , Poland
Psychiatry&Neurol.Instit.Interv.Stroke&Cerebrov.Treatm.Cntr
Warsaw, , Poland
Hospital Fernando Fonseca, EPE
Amadora, , Portugal
CHLO, EPE - Hospital Egas Moniz
Lisbon, , Portugal
CHULN, EPE - Hospital de Santa Maria
Lisbon, , Portugal
Centro Hospitalar São João,EPE
Porto, , Portugal
Centro Hospitalar de Entre o Douro e Vouga, E.P.E. - Hospital de São Sebastião
Santa Maria da Feira, , Portugal
Reg.State Budget Hlthcare,City Hosp#5,Neurology Dept,Barnaul
Barnaul, , Russia
Interreg. Clinical & Diagnostic Center, Neurol. Dept., Kazan
Kazan', , Russia
St.Petersb,State Hlthcare Instit. Elisabeth Hosp,Neurol.dept
Saint Petersburg, , Russia
Sverdlovsk Reg.Clin.Hosp.No.1
Yekaterinburg, , Russia
Hospital Ramón y Cajal
Madrid, , Spain
Hospital La Paz
Madrid, , Spain
Countries
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References
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Ferro JM, Bendszus M, Jansen O, Coutinho JM, Dentali F, Kobayashi A, Aguiar de Sousa D, Neto LL, Miede C, Caria J, Huisman H, Diener HC; RE-SPECT CVT Study Group. Recanalization after cerebral venous thrombosis. A randomized controlled trial of the safety and efficacy of dabigatran etexilate versus dose-adjusted warfarin in patients with cerebral venous and dural sinus thrombosis. Int J Stroke. 2022 Feb;17(2):189-197. doi: 10.1177/17474930211006303. Epub 2021 Apr 4.
Ferro JM, Coutinho JM, Jansen O, Bendszus M, Dentali F, Kobayashi A, van der Veen B, Miede C, Caria J, Huisman H, Diener HC; RE-SPECT CVT Study Group. Dural Arteriovenous Fistulae After Cerebral Venous Thrombosis. Stroke. 2020 Nov;51(11):3344-3347. doi: 10.1161/STROKEAHA.120.031235. Epub 2020 Sep 25.
Ferro JM, Coutinho JM, Dentali F, Kobayashi A, Alasheev A, Canhao P, Karpov D, Nagel S, Posthuma L, Roriz JM, Caria J, Frassdorf M, Huisman H, Reilly P, Diener HC; RE-SPECT CVT Study Group. Safety and Efficacy of Dabigatran Etexilate vs Dose-Adjusted Warfarin in Patients With Cerebral Venous Thrombosis: A Randomized Clinical Trial. JAMA Neurol. 2019 Dec 1;76(12):1457-1465. doi: 10.1001/jamaneurol.2019.2764.
Ferro JM, Dentali F, Coutinho JM, Kobayashi A, Caria J, Desch M, Fraessdorf M, Huisman H, Diener HC. Rationale, design, and protocol of a randomized controlled trial of the safety and efficacy of dabigatran etexilate versus dose-adjusted warfarin in patients with cerebral venous thrombosis. Int J Stroke. 2018 Oct;13(7):766-770. doi: 10.1177/1747493018778125. Epub 2018 May 18.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2015-004412-38
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
1160.248
Identifier Type: -
Identifier Source: org_study_id
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