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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)

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ClinicalTrials.gov Identifier: NCT02913326
Recruitment Status : Completed
First Posted : September 23, 2016
Results First Posted : August 15, 2019
Last Update Posted : August 15, 2019
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Tracking Information
First Submitted Date  ICMJE September 21, 2016
First Posted Date  ICMJE September 23, 2016
Results First Submitted Date  ICMJE June 3, 2019
Results First Posted Date  ICMJE August 15, 2019
Last Update Posted Date August 15, 2019
Actual Study Start Date  ICMJE December 13, 2016
Actual Primary Completion Date June 22, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 9, 2019)
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. [ Time Frame: From first administration of trial medication until 6 days after last administration of trial medication, up to 25 weeks. ]
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
Original Primary Outcome Measures  ICMJE
 (submitted: September 21, 2016)
Composite of the number of patients with major bleeding according to ISTH criteria and Venous Thrombotic Event (VTE) (recurring CVT; deep venous thrombosis of any limb, pulmonary embolism, splanchnic vein thrombosis) after up to 24 weeks [ Time Frame: up to 24 weeks ]
Change History Complete list of historical versions of study NCT02913326 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 9, 2019)
  • Percentage of Participants With Recurring Cerebral Venous and Dural Sinus Thrombosis; DVT of Any Limb, PE or Splanchnic Vein Thrombosis in Full Observation Period [ Time Frame: From first administration of trial medication until 6 days after last administration of trial medication, up to 25 weeks. ]
    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 [ Time Frame: Baseline and 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 [ Time Frame: From first administration of trial medication until 6 days after last administration of trial medication, up to 25 weeks. ]
    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 [ Time Frame: From first administration of trial medication until end of treatment visit, 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. [ Time Frame: From first administration of trial medication until 6 days after last administration of trial medication, up to 25 weeks. ]
    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 [ Time Frame: From first administration of trial medication until end of treatment visit, 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 [ Time Frame: From first administration of trial medication until end of treatment visit, 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: September 21, 2016)
  • Cerebral venous recanalisation as measured by the change in number of occluded cerebral veins and sinuses after up to 24 weeks [ Time Frame: up to 24 weeks ]
  • Number of patients with any bleeding event after up to 24 weeks [ Time Frame: up to 24 weeks ]
  • Number of patients with recurring cerebral venous and dural sinus thrombosis; deep venous thrombosis of any limb, pulmonary embolism or splanchnic vein thrombosis after up to 24 weeks [ Time Frame: up to 24 weeks ]
  • Number of patients with major bleeding according to International Society on Thrombosis and Haemostasis criteria after up to 24 weeks [ Time Frame: up to 24 weeks ]
  • Composite endpoint of number of patients with new Intracranial haemorrhage or worsening of the haemorrhagic component of a previous lesion after up to 24 weeks [ Time Frame: up to 24 weeks ]
  • Number of patients with clinically relevant non-major bleeding events after up to 24 weeks [ Time Frame: up to 24 weeks ]
  • Number of patients with major bleeding according to International Society on Thrombosis and Haemostasis criteria or clinically relevant non-major bleeding events after up to 24 weeks [ Time Frame: up to 24 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Thromboembolism
Intervention  ICMJE
  • Drug: Dabigatran etexilate
  • Drug: Warfarin
Study Arms  ICMJE
  • Experimental: Dabigatran etexilate
    Intervention: Drug: Dabigatran etexilate
  • Active Comparator: Warfarin
    Intervention: Drug: Warfarin
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 19, 2016)
120
Original Estimated Enrollment  ICMJE
 (submitted: September 21, 2016)
180
Actual Study Completion Date  ICMJE June 22, 2018
Actual Primary Completion Date June 22, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 78 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France,   Germany,   India,   Italy,   Netherlands,   Poland,   Portugal,   Russian Federation,   Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02913326
Other Study ID Numbers  ICMJE 1160.248
2015-004412-38 ( EudraCT Number )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Boehringer Ingelheim
Study Sponsor  ICMJE Boehringer Ingelheim
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
PRS Account Boehringer Ingelheim
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP