A Clinical Trial Comparing Efficacy and Safety of Dabigatran Etexilate With Warfarin in Patients With Cerebral Venous and Dural Sinus Thrombosis (RE-SPECT CVT)
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
2 other identifiers
interventional
120
9 countries
36
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Dec 2016
36 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 21, 2016
CompletedFirst Posted
Study publicly available on registry
September 23, 2016
CompletedStudy Start
First participant enrolled
December 13, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 22, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
June 22, 2018
CompletedResults Posted
Study results publicly available
August 15, 2019
CompletedAugust 15, 2019
August 1, 2019
1.5 years
September 21, 2016
June 3, 2019
August 9, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
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.
Composite of the percentage of participants with MBE according to ISTH criteria and VTE (recurring cerebral venous thrombosis (CVT); deep venous thrombosis (DVT) of any limb, pulmonary embolism (PE), splanchnic vein thrombosis) in full observation period. All components were adjudicated in a blinded manner. Major bleeds were defined according to the ISTH definition of a major bleed, as follows: * Symptomatic bleeding in a critical area or organ, such as intracranial, intraspinal, intraocular, retroperitoneal, intra-articular or pericardial, or intramuscular with compartment syndrome and/or * Bleeding associated with a reduction in haemoglobin of at least 2 grams/deciLitre (1.24 millimole/Litre) within 24 h, or leading to transfusion of 2 or more units of blood or packed cells and/or * Fatal bleed
From first administration of trial medication until 6 days after last administration of trial medication, up to 25 weeks.
Secondary Outcomes (7)
Percentage of Participants With Recurring Cerebral Venous and Dural Sinus Thrombosis; DVT of Any Limb, PE or Splanchnic Vein Thrombosis in Full Observation Period
From first administration of trial medication until 6 days after last administration of trial medication, up to 25 weeks.
Cerebral Venous Recanalisation as Measured by the Change in Number of Occluded Cerebral Veins and Sinuses at Week 24
Baseline and week 24
Percentage of Participants With Major Bleeding According to ISTH Criteria in Full Observation Period
From first administration of trial medication until 6 days after last administration of trial medication, up to 25 weeks.
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
From first administration of trial medication until end of treatment visit, up to 24 weeks.
Percentage of Participants With Clinically Relevant Non-major Bleeding Events in Full Observation Period.
From first administration of trial medication until 6 days after last administration of trial medication, up to 25 weeks.
- +2 more secondary outcomes
Study Arms (2)
Dabigatran etexilate
EXPERIMENTALWarfarin
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (36)
HOP Pellegrin
Bordeaux, 33076, France
HOP Lariboisière
Paris, 75475, France
Vivantes Netzwerk für Gesundheit GmbH
Berlin, 12351, Germany
Universitätsklinikum Essen AöR
Essen, 45147, Germany
Asklepios Klinik Wandsbek
Hamburg, 22043, Germany
Universitätsklinikum Heidelberg
Heidelberg, 69120, Germany
Universitätsklinikum Tübingen
Tübingen, 72076, Germany
Mazumdar Shaw Medical centre
Bangalore, 560099, India
Nizam's Institute of Medical Sciences
Hyderabad, 500082, India
Caritas Hospital
Kottayam, 686630, India
Magnum Heart Institute
Nashik, 422005, India
All India Institute of Medical Sciences
New Delhi, 110029, India
Sahyadri Speciality Hospital
Pune, 411004, India
ASST di Cremona
Cremona, 26100, Italy
Fondazione Centro San Raffaele del Monte Tabor
Milan, 20132, Italy
Nuovo Ospedale Civile S. Agostino-Estense
Modena, 41126, Italy
A.O. San Camillo Forlanini
Roma, 00152, Italy
Umberto I Pol. di Roma-Università di Roma La Sapienza
Roma, 00161, Italy
A. O. Ospedale Circolo Fond. Macchi
Varese, 21100, Italy
Academisch Medisch Centrum (AMC)
Amsterdam, 1105 AZ, Netherlands
Universitair Medisch Centrum Utrecht
Utrecht, 3584 CX, Netherlands
University Clinical Center, Gdansk
Gdansk, 80211, Poland
Copernicus Med.Company.Ltd,Hosp.Nicolaus, Gdansk
Gdansk, 80803, Poland
Independent Public Clin.Hospital No.4,Neurol.Dept,Lublin
Lublin, 20-954, Poland
Psychiatry&Neurol.Instit.Interv.Stroke&Cerebrov.Treatm.Cntr
Warsaw, 02-957, Poland
Hospital Fernando Fonseca, EPE
Amadora, 2720-276, Portugal
CHLO, EPE - Hospital Egas Moniz
Lisbon, 1349-019, Portugal
CHULN, EPE - Hospital de Santa Maria
Lisbon, 1649-035, Portugal
Centro Hospitalar São João,EPE
Porto, 4202-451, Portugal
Centro Hospitalar de Entre o Douro e Vouga, E.P.E. - Hospital de São Sebastião
Santa Maria da Feira, 4520-211, Portugal
Reg.State Budget Hlthcare,City Hosp#5,Neurology Dept,Barnaul
Barnaul, 656045, Russia
Interreg. Clinical & Diagnostic Center, Neurol. Dept., Kazan
Kazan', 420101, Russia
St.Petersb,State Hlthcare Instit. Elisabeth Hosp,Neurol.dept
Saint Petersburg, 195257, Russia
Sverdlovsk Reg.Clin.Hosp.No.1
Yekaterinburg, 620102, Russia
Hospital Ramón y Cajal
Madrid, 28034, Spain
Hospital La Paz
Madrid, 28046, Spain
Related Publications (4)
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.
PMID: 33724104DERIVEDFerro 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.
PMID: 32972315DERIVEDFerro 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.
PMID: 31479105DERIVEDFerro 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.
PMID: 29775170DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Boehringer Ingelheim, Call Center
- Organization
- Boehringer Ingelheim
Study Officials
- STUDY CHAIR
Boehringer Ingelheim
Boehringer Ingelheim
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 21, 2016
First Posted
September 23, 2016
Study Start
December 13, 2016
Primary Completion
June 22, 2018
Study Completion
June 22, 2018
Last Updated
August 15, 2019
Results First Posted
August 15, 2019
Record last verified: 2019-08