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A Clinical Trial Comparing Efficacy and Safety of Dabigatran Etexilate With Warfarin in Patients With Cerebral Venous and Dural Sinus Thrombosis (RE-SPECT CVT)

Primary Purpose

Thromboembolism

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Dabigatran etexilate
Warfarin
Sponsored by
Boehringer Ingelheim
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Thromboembolism

Eligibility Criteria

18 Years - 78 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • HOP Pellegrin
  • HOP Lariboisière
  • Vivantes Netzwerk für Gesundheit GmbH
  • Universitätsklinikum Essen AöR
  • Asklepios Klinik Wandsbek
  • Universitätsklinikum Heidelberg
  • Universitätsklinikum Tübingen
  • Mazumdar Shaw Medical centre
  • Nizam's Institute of Medical Sciences
  • Caritas Hospital
  • Magnum Heart Institute
  • All India Institute of Medical Sciences
  • Sahyadri Speciality Hospital
  • ASST di Cremona
  • Fondazione Centro San Raffaele del Monte Tabor
  • Nuovo Ospedale Civile S. Agostino-Estense
  • A.O. San Camillo Forlanini
  • Umberto I Pol. di Roma-Università di Roma La Sapienza
  • A. O. Ospedale Circolo Fond. Macchi
  • Academisch Medisch Centrum (AMC)
  • Universitair Medisch Centrum Utrecht
  • University Clinical Center, Gdansk
  • Copernicus Med.Company.Ltd,Hosp.Nicolaus, Gdansk
  • Independent Public Clin.Hospital No.4,Neurol.Dept,Lublin
  • Psychiatry&Neurol.Instit.Interv.Stroke&Cerebrov.Treatm.Cntr
  • Hospital Fernando Fonseca, EPE
  • CHLO, EPE - Hospital Egas Moniz
  • CHULN, EPE - Hospital de Santa Maria
  • Centro Hospitalar São João,EPE
  • Centro Hospitalar de Entre o Douro e Vouga, E.P.E. - Hospital de São Sebastião
  • Reg.State Budget Hlthcare,City Hosp#5,Neurology Dept,Barnaul
  • Interreg. Clinical & Diagnostic Center, Neurol. Dept., Kazan
  • St.Petersb,State Hlthcare Instit. Elisabeth Hosp,Neurol.dept
  • Sverdlovsk Reg.Clin.Hosp.No.1
  • Hospital Ramón y Cajal
  • Hospital La Paz

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Dabigatran etexilate

Warfarin

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Percentage of Participants With Recurring Cerebral Venous and Dural Sinus Thrombosis; DVT of Any Limb, PE or Splanchnic Vein Thrombosis in Full Observation Period
VTE criterions: New neurological signs/symptoms or worsening of previous signs/symptoms with new CVT on neuroimaging. DVT of any limb was documented by: Abnormal compression ultrasonography; An intraluminal filling defect on venography; At autopsy Splanchnic vein thrombosis: The presence of endoluminal material/absence of flow in the extrahepatic portal veins/mesenteric veins as shown by duplex-Doppler ultrasound/contrast-enhanced CT scan/MRI. PE was documented by: An intraluminal filling defect in segmental/more proximal branches on spiral CT scan; An intraluminal filling defect/an extension of an existing defect/a sudden cut-off of vessels>2.5 mm in diameter on the pulmonary angiogram; Perfusion defect of at least 75% of a segment with a local normal ventilation result on ventilation/perfusion lung scan; Inconclusive spiral CT, pulmonary angiography/lung scintigraphy with demonstration of DVT in the lower extremities by compression ultrasonography/venography; At autopsy.
Cerebral Venous Recanalisation as Measured by the Change in Number of Occluded Cerebral Veins and Sinuses at Week 24
Cerebral venous recanalisation was assessed by imaging and was adjudicated. Occlusion of cerebral veins and sinuses was scored as: 1 = full occlusion; 0 = no occlusion/partial occlusion. This score was applied using the below conventions: Superior sagittal, straight, cavernous sinuses, left and right jugular veins each scored individually as either 0 or 1; Right lateral transverse and sigmoid sinus were scored together, Left lateral transverse and sigmoid sinus were scored together, Superior petrous sinus and inferior petrous sinus were scored together; Deep venous system, Superficial cortical veins, Cerebellar veins were scored as systems. For each patient a total score was calculated at baseline and at EOT and the recanalisation score was calculated as EOT - baseline total scores with conventions as 0 = no cerebral veins or sinuses fully occluded and 11 = all cerebral veins and sinuses fully occluded; the lower the score, the better.
Percentage of Participants With Major Bleeding According to ISTH Criteria in Full Observation Period
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
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
Intracranial haemorrhage (ICH) comprised the subtypes of intracerebral bleeds, subdural bleeds, epidural bleeds and subarachnoid bleeds that were recorded.
Percentage of Participants With Clinically Relevant Non-major Bleeding Events in Full Observation Period.
A clinically relevant non-major bleeding event (CRNMBE) was a clinically overt bleed that did not meet the criteria for a major bleed but prompted a clinical response, in that it led to at least 1 of the following: A hospital admission (i.e. overnight stay in the hospital) for bleeding / A physician guided medical or surgical treatment for bleeding / A physician guided change, interruption or discontinuation of trial medication.
Percentage of Participants With Major Bleeding According to ISTH Criteria or CRNMBEs After up to 24 Weeks
Percentage of participants with major bleeding according to ISTH criteria or CRNMBEs after up to 24 weeks.
Percentage of Participants With Any Bleeding Event After up to 24 Weeks
Percentage of participants with any bleeding event after up to 24 weeks where any bleeding event is the sum of all major and non-major bleeding events.

Full Information

First Posted
September 21, 2016
Last Updated
August 9, 2019
Sponsor
Boehringer Ingelheim
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1. Study Identification

Unique Protocol Identification Number
NCT02913326
Brief Title
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

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
December 13, 2016 (Actual)
Primary Completion Date
June 22, 2018 (Actual)
Study Completion Date
June 22, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boehringer Ingelheim

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thromboembolism

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dabigatran etexilate
Arm Type
Experimental
Arm Title
Warfarin
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Dabigatran etexilate
Intervention Type
Drug
Intervention Name(s)
Warfarin
Primary Outcome Measure Information:
Title
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.
Description
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
Time Frame
From first administration of trial medication until 6 days after last administration of trial medication, up to 25 weeks.
Secondary Outcome Measure Information:
Title
Percentage of Participants With Recurring Cerebral Venous and Dural Sinus Thrombosis; DVT of Any Limb, PE or Splanchnic Vein Thrombosis in Full Observation Period
Description
VTE criterions: New neurological signs/symptoms or worsening of previous signs/symptoms with new CVT on neuroimaging. DVT of any limb was documented by: Abnormal compression ultrasonography; An intraluminal filling defect on venography; At autopsy Splanchnic vein thrombosis: The presence of endoluminal material/absence of flow in the extrahepatic portal veins/mesenteric veins as shown by duplex-Doppler ultrasound/contrast-enhanced CT scan/MRI. PE was documented by: An intraluminal filling defect in segmental/more proximal branches on spiral CT scan; An intraluminal filling defect/an extension of an existing defect/a sudden cut-off of vessels>2.5 mm in diameter on the pulmonary angiogram; Perfusion defect of at least 75% of a segment with a local normal ventilation result on ventilation/perfusion lung scan; Inconclusive spiral CT, pulmonary angiography/lung scintigraphy with demonstration of DVT in the lower extremities by compression ultrasonography/venography; At autopsy.
Time Frame
From first administration of trial medication until 6 days after last administration of trial medication, up to 25 weeks.
Title
Cerebral Venous Recanalisation as Measured by the Change in Number of Occluded Cerebral Veins and Sinuses at Week 24
Description
Cerebral venous recanalisation was assessed by imaging and was adjudicated. Occlusion of cerebral veins and sinuses was scored as: 1 = full occlusion; 0 = no occlusion/partial occlusion. This score was applied using the below conventions: Superior sagittal, straight, cavernous sinuses, left and right jugular veins each scored individually as either 0 or 1; Right lateral transverse and sigmoid sinus were scored together, Left lateral transverse and sigmoid sinus were scored together, Superior petrous sinus and inferior petrous sinus were scored together; Deep venous system, Superficial cortical veins, Cerebellar veins were scored as systems. For each patient a total score was calculated at baseline and at EOT and the recanalisation score was calculated as EOT - baseline total scores with conventions as 0 = no cerebral veins or sinuses fully occluded and 11 = all cerebral veins and sinuses fully occluded; the lower the score, the better.
Time Frame
Baseline and week 24
Title
Percentage of Participants With Major Bleeding According to ISTH Criteria in Full Observation Period
Description
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
Time Frame
From first administration of trial medication until 6 days after last administration of trial medication, up to 25 weeks.
Title
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
Description
Intracranial haemorrhage (ICH) comprised the subtypes of intracerebral bleeds, subdural bleeds, epidural bleeds and subarachnoid bleeds that were recorded.
Time Frame
From first administration of trial medication until end of treatment visit, up to 24 weeks.
Title
Percentage of Participants With Clinically Relevant Non-major Bleeding Events in Full Observation Period.
Description
A clinically relevant non-major bleeding event (CRNMBE) was a clinically overt bleed that did not meet the criteria for a major bleed but prompted a clinical response, in that it led to at least 1 of the following: A hospital admission (i.e. overnight stay in the hospital) for bleeding / A physician guided medical or surgical treatment for bleeding / A physician guided change, interruption or discontinuation of trial medication.
Time Frame
From first administration of trial medication until 6 days after last administration of trial medication, up to 25 weeks.
Title
Percentage of Participants With Major Bleeding According to ISTH Criteria or CRNMBEs After up to 24 Weeks
Description
Percentage of participants with major bleeding according to ISTH criteria or CRNMBEs after up to 24 weeks.
Time Frame
From first administration of trial medication until end of treatment visit, up to 24 weeks.
Title
Percentage of Participants With Any Bleeding Event After up to 24 Weeks
Description
Percentage of participants with any bleeding event after up to 24 weeks where any bleeding event is the sum of all major and non-major bleeding events.
Time Frame
From first administration of trial medication until end of treatment visit, up to 24 weeks.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
78 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Organizational Affiliation
Boehringer Ingelheim
Official's Role
Study Chair
Facility Information:
Facility Name
HOP Pellegrin
City
Bordeaux
ZIP/Postal Code
33076
Country
France
Facility Name
HOP Lariboisière
City
Paris
ZIP/Postal Code
75475
Country
France
Facility Name
Vivantes Netzwerk für Gesundheit GmbH
City
Berlin
ZIP/Postal Code
12351
Country
Germany
Facility Name
Universitätsklinikum Essen AöR
City
Essen
ZIP/Postal Code
45147
Country
Germany
Facility Name
Asklepios Klinik Wandsbek
City
Hamburg
ZIP/Postal Code
22043
Country
Germany
Facility Name
Universitätsklinikum Heidelberg
City
Heidelberg
ZIP/Postal Code
69120
Country
Germany
Facility Name
Universitätsklinikum Tübingen
City
Tübingen
ZIP/Postal Code
72076
Country
Germany
Facility Name
Mazumdar Shaw Medical centre
City
Bangalore
ZIP/Postal Code
560099
Country
India
Facility Name
Nizam's Institute of Medical Sciences
City
Hyderabad
ZIP/Postal Code
500082
Country
India
Facility Name
Caritas Hospital
City
Kottayam
ZIP/Postal Code
686630
Country
India
Facility Name
Magnum Heart Institute
City
Nashik
ZIP/Postal Code
422005
Country
India
Facility Name
All India Institute of Medical Sciences
City
New Delhi
ZIP/Postal Code
110029
Country
India
Facility Name
Sahyadri Speciality Hospital
City
Pune
ZIP/Postal Code
411004
Country
India
Facility Name
ASST di Cremona
City
Cremona
ZIP/Postal Code
26100
Country
Italy
Facility Name
Fondazione Centro San Raffaele del Monte Tabor
City
Milano
ZIP/Postal Code
20132
Country
Italy
Facility Name
Nuovo Ospedale Civile S. Agostino-Estense
City
Modena
ZIP/Postal Code
41126
Country
Italy
Facility Name
A.O. San Camillo Forlanini
City
Roma
ZIP/Postal Code
00152
Country
Italy
Facility Name
Umberto I Pol. di Roma-Università di Roma La Sapienza
City
Roma
ZIP/Postal Code
00161
Country
Italy
Facility Name
A. O. Ospedale Circolo Fond. Macchi
City
Varese
ZIP/Postal Code
21100
Country
Italy
Facility Name
Academisch Medisch Centrum (AMC)
City
Amsterdam
ZIP/Postal Code
1105 AZ
Country
Netherlands
Facility Name
Universitair Medisch Centrum Utrecht
City
Utrecht
ZIP/Postal Code
3584 CX
Country
Netherlands
Facility Name
University Clinical Center, Gdansk
City
Gdansk
ZIP/Postal Code
80211
Country
Poland
Facility Name
Copernicus Med.Company.Ltd,Hosp.Nicolaus, Gdansk
City
Gdansk
ZIP/Postal Code
80803
Country
Poland
Facility Name
Independent Public Clin.Hospital No.4,Neurol.Dept,Lublin
City
Lublin
ZIP/Postal Code
20-954
Country
Poland
Facility Name
Psychiatry&Neurol.Instit.Interv.Stroke&Cerebrov.Treatm.Cntr
City
Warsaw
ZIP/Postal Code
02-957
Country
Poland
Facility Name
Hospital Fernando Fonseca, EPE
City
Amadora
ZIP/Postal Code
2720-276
Country
Portugal
Facility Name
CHLO, EPE - Hospital Egas Moniz
City
Lisboa
ZIP/Postal Code
1349-019
Country
Portugal
Facility Name
CHULN, EPE - Hospital de Santa Maria
City
Lisboa
ZIP/Postal Code
1649-035
Country
Portugal
Facility Name
Centro Hospitalar São João,EPE
City
Porto
ZIP/Postal Code
4202-451
Country
Portugal
Facility Name
Centro Hospitalar de Entre o Douro e Vouga, E.P.E. - Hospital de São Sebastião
City
Santa Maria da Feira
ZIP/Postal Code
4520-211
Country
Portugal
Facility Name
Reg.State Budget Hlthcare,City Hosp#5,Neurology Dept,Barnaul
City
Barnaul
ZIP/Postal Code
656045
Country
Russian Federation
Facility Name
Interreg. Clinical & Diagnostic Center, Neurol. Dept., Kazan
City
Kazan
ZIP/Postal Code
420101
Country
Russian Federation
Facility Name
St.Petersb,State Hlthcare Instit. Elisabeth Hosp,Neurol.dept
City
Saint Petersburg
ZIP/Postal Code
195257
Country
Russian Federation
Facility Name
Sverdlovsk Reg.Clin.Hosp.No.1
City
Yekaterinburg
ZIP/Postal Code
620102
Country
Russian Federation
Facility Name
Hospital Ramón y Cajal
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Facility Name
Hospital La Paz
City
Madrid
ZIP/Postal Code
28046
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
33724104
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.
Results Reference
derived
PubMed Identifier
32972315
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.
Results Reference
derived
PubMed Identifier
31479105
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.
Results Reference
derived
PubMed Identifier
29775170
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.
Results Reference
derived
Links:
URL
http://trials.boehringer-ingelheim.com/
Description
Related Info

Learn more about this trial

A Clinical Trial Comparing Efficacy and Safety of Dabigatran Etexilate With Warfarin in Patients With Cerebral Venous and Dural Sinus Thrombosis (RE-SPECT CVT)

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