Clinical trial NCT02913326: A Clinical Trial Comparing Efficacy and Safety of Dabigatran Etexilate With Warfarin in Patients With Cerebral Venous and Dural Sinus Thrombosis (RE-SPECT CVT)
Official title: RE-SPECT CVT: a Randomised, Open-label, Exploratory Trial With Blinded Endpoint Adjudication (PROBE), Comparing Efficacy and Safety of Oral Dabigatran Etexilate Versus Oral Warfarin in Patients With Cerebral Venous and Dural Sinus Thrombosis Over a 24-week Period
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Thromboembolism
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2016-09-23
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 78
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a multi-center, prospective, international, randomized (1:1), open-label study with two parallel groups. This phase III study is planned to investigate the efficacy and safety of dabigatran etexilate versus dose-adjusted warfarin on a net clinical benefit endpoint of major bleeding (ISTH criteria) and new venous thrombotic event (VTE) (primary endpoint) with blinded endpoint adjudication.


Eligibility criteria: Inclusion criteria:

* Written informed consent in accordance with International Conference on Harmonization (ICH) Good Clinical Practice (GCP) guidelines and local legislation and/or regulations
* 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
* Further inclusion criteria apply

Exclusion criteria:

* Cerebral Venous or dural sinus thrombosis (CVT) associated with central nervous system infection or due to head trauma
* 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
* Further exclusion criteria apply

Primary outcomes:
measure: Percentage of Participants With Composite of Venous Thrombotic Event (VTE) or Major Bleeding Event (MBE) According to International Society on Thrombosis and Haemostasis (ISTH) Criteria in Full Observation Period.
timeFrame: From first administration of trial medication until 6 days after last administration of trial medication, up to 25 weeks.
Secondary outcomes:
measure: Percentage of Participants With Recurring Cerebral Venous and Dural Sinus Thrombosis; DVT of Any Limb, PE or Splanchnic Vein Thrombosis in Full Observation Period
timeFrame: From first administration of trial medication until 6 days after last administration of trial medication, up to 25 weeks.
measure: Cerebral Venous Recanalisation as Measured by the Change in Number of Occluded Cerebral Veins and Sinuses at Week 24
timeFrame: Baseline and week 24
measure: Percentage of Participants With Major Bleeding According to ISTH Criteria in Full Observation Period
timeFrame: From first administration of trial medication until 6 days after last administration of trial medication, up to 25 weeks.
measure: Composite Endpoint of Percentage of Participants With New Intracranial Haemorrhage or Worsening of the Haemorrhagic Component of a Previous Lesion After up to 24 Weeks
timeFrame: From first administration of trial medication until end of treatment visit, up to 24 weeks.
measure: Percentage of Participants With Clinically Relevant Non-major Bleeding Events in Full Observation Period.
timeFrame: From first administration of trial medication until 6 days after last administration of trial medication, up to 25 weeks.
measure: Percentage of Participants With Major Bleeding According to ISTH Criteria or CRNMBEs After up to 24 Weeks
timeFrame: From first administration of trial medication until end of treatment visit, up to 24 weeks.
measure: Percentage of Participants With Any Bleeding Event After up to 24 Weeks
timeFrame: From first administration of trial medication until end of treatment visit, up to 24 weeks.
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: HOP Pellegrin
city: Paris
country: France
facility: HOP Lariboisière
city: Berlin
country: Germany
facility: Vivantes Netzwerk für Gesundheit GmbH
city: Essen
country: Germany
facility: Universitätsklinikum Essen AöR
city: Hamburg
country: Germany
facility: Asklepios Klinik Wandsbek
city: Heidelberg
country: Germany
facility: Universitätsklinikum Heidelberg
city: Tübingen
country: Germany
facility: Universitätsklinikum Tübingen
city: Bangalore
country: India
facility: Mazumdar Shaw Medical centre
city: Hyderabad
country: India
facility: Nizam's Institute of Medical Sciences
city: Kottayam
country: India
facility: Caritas Hospital
city: Nashik
country: India
facility: Magnum Heart Institute
city: New Delhi
country: India
facility: All India Institute of Medical Sciences
city: Pune
country: India
facility: Sahyadri Speciality Hospital
city: Cremona
country: Italy
facility: ASST di Cremona
city: Milano
country: Italy
facility: Fondazione Centro San Raffaele del Monte Tabor
city: Modena
country: Italy
facility: Nuovo Ospedale Civile S. Agostino-Estense
city: Roma
country: Italy
facility: A.O. San Camillo Forlanini
city: Roma
country: Italy
facility: Umberto I Pol. di Roma-Università di Roma La Sapienza
city: Varese
country: Italy
facility: A. O. Ospedale Circolo Fond. Macchi
city: Amsterdam
country: Netherlands
facility: Academisch Medisch Centrum (AMC)
city: Utrecht
country: Netherlands
facility: Universitair Medisch Centrum Utrecht
city: Gdansk
country: Poland
facility: University Clinical Center, Gdansk
city: Gdansk
country: Poland
facility: Copernicus Med.Company.Ltd,Hosp.Nicolaus, Gdansk
city: Lublin
country: Poland
facility: Independent Public Clin.Hospital No.4,Neurol.Dept,Lublin
city: Warsaw
country: Poland
facility: Psychiatry&Neurol.Instit.Interv.Stroke&Cerebrov.Treatm.Cntr
city: Amadora
country: Portugal
facility: Hospital Fernando Fonseca, EPE
city: Lisboa
country: Portugal
facility: CHLO, EPE - Hospital Egas Moniz
city: Lisboa
country: Portugal
facility: CHULN, EPE - Hospital de Santa Maria
city: Porto
country: Portugal
facility: Centro Hospitalar São João,EPE
city: Santa Maria da Feira
country: Portugal
facility: Centro Hospitalar de Entre o Douro e Vouga, E.P.E. - Hospital de São Sebastião
city: Barnaul
country: Russian Federation
facility: Reg.State Budget Hlthcare,City Hosp#5,Neurology Dept,Barnaul
city: Kazan
country: Russian Federation
facility: Interreg. Clinical & Diagnostic Center, Neurol. Dept., Kazan
city: Saint Petersburg
country: Russian Federation
facility: St.Petersb,State Hlthcare Instit. Elisabeth Hosp,Neurol.dept
city: Yekaterinburg
country: Russian Federation
facility: Sverdlovsk Reg.Clin.Hosp.No.1
city: Madrid
country: Spain
facility: Hospital Ramón y Cajal
city: Madrid
country: Spain
facility: Hospital La Paz
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.