ThromboembolismPhase 3NCT02913326
A Clinical Trial Comparing Efficacy and Safety of Dabigatran Etexilate With Warfarin in Patients With Cerebral Venous and Dural Sinus Thrombosis (RE-SPECT CVT)
A Phase 3 study testing Dabigatran etexilate and Warfarin in people with Thromboembolism, run by Boehringer Ingelheim at 36 sites in 9 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 78 years
- Conditions the study is for
- Thromboembolism
- What is being tested?
- Dabigatran etexilate and Warfarin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 36 sitesin 9 countries
- Study dates
- 13 Dec 2016to 22 Jun 2018
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 78 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- Active liver disease
- Pregnancy, nursing or planning to become pregnant while in the trial
- Further exclusion criteria apply
Trial locations and contacts
36 sites in 9 countries.
36 sites in 9 countries
India6 sites
Mazumdar Shaw Medical centre
Bangalore, 560099
Nizam's Institute of Medical Sciences
Hyderabad, 500082
Caritas Hospital
Kottayam, 686630
Magnum Heart Institute
Nashik, 422005
All India Institute of Medical Sciences
New Delhi, 110029
Sahyadri Speciality Hospital
Pune, 411004
Italy6 sites
ASST di Cremona
Cremona, 26100
Fondazione Centro San Raffaele del Monte Tabor
Milan, 20132
Nuovo Ospedale Civile S. Agostino-Estense
Modena, 41126
A.O. San Camillo Forlanini
Roma, 00152
Umberto I Pol. di Roma-Università di Roma La Sapienza
Roma, 00161
A. O. Ospedale Circolo Fond. Macchi
Varese, 21100
Germany5 sites
Vivantes Netzwerk für Gesundheit GmbH
Berlin, 12351
Universitätsklinikum Essen AöR
Essen, 45147
Asklepios Klinik Wandsbek
Hamburg, 22043
Universitätsklinikum Heidelberg
Heidelberg, 69120
Universitätsklinikum Tübingen
Tübingen, 72076
Portugal5 sites
Hospital Fernando Fonseca, EPE
Amadora, 2720-276
CHLO, EPE - Hospital Egas Moniz
Lisbon, 1349-019
CHULN, EPE - Hospital de Santa Maria
Lisbon, 1649-035
Centro Hospitalar São João,EPE
Porto, 4202-451
Centro Hospitalar de Entre o Douro e Vouga, E.P.E. - Hospital de São Sebastião
Santa Maria da Feira, 4520-211
Poland4 sites
University Clinical Center, Gdansk
Gdansk, 80211
Copernicus Med.Company.Ltd,Hosp.Nicolaus, Gdansk
Gdansk, 80803
Independent Public Clin.Hospital No.4,Neurol.Dept,Lublin
Lublin, 20-954
Psychiatry&Neurol.Instit.Interv.Stroke&Cerebrov.Treatm.Cntr
Warsaw, 02-957
Russia4 sites
Reg.State Budget Hlthcare,City Hosp#5,Neurology Dept,Barnaul
Barnaul, 656045
Interreg. Clinical & Diagnostic Center, Neurol. Dept., Kazan
Kazan', 420101
St.Petersb,State Hlthcare Instit. Elisabeth Hosp,Neurol.dept
Saint Petersburg, 195257
Sverdlovsk Reg.Clin.Hosp.No.1
Yekaterinburg, 620102
Netherlands2 sites
Academisch Medisch Centrum (AMC)
Amsterdam, 1105 AZ
Universitair Medisch Centrum Utrecht
Utrecht, 3584 CX
About this study
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
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.
- Conditions
- Thromboembolism
- Being tested
- Dabigatran etexilate, Warfarin
- Medical subject headings
- Thromboembolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dabigatran etexilateDrug
WarfarinDrug
| Study group | Role | What they receive |
|---|---|---|
| Dabigatran etexilate | Experimental | Not described Receives: Drug: Dabigatran etexilate |
| Warfarin | Active comparator | Not described Receives: Drug: Warfarin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
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.
Measured: 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
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.
Measured: Baseline and week 24
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
Measured: 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
Intracranial haemorrhage (ICH) comprised the subtypes of intracerebral bleeds, subdural bleeds, epidural bleeds and subarachnoid bleeds that were recorded.
Measured: 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.
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.
Measured: From first administration of trial medication until 6 days after last administration of trial medication, up to 25 weeks.
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.
Measured: 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
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.
Measured: From first administration of trial medication until end of treatment visit, up to 24 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2016 (estimated)
- Study start13 Dec 2016
- Primary completion22 Jun 2018
- Study completion22 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for ThromboembolismStudies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Boehringer Ingelheim, Study chair, Boehringer Ingelheim
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02913326
- Sponsor's protocol ID
- 1160.248
- Other IDs
- 2015-004412-38, 2015
- Status last verified
- Aug 2019
- First submitted
- 21 Sep 2016
- Last updated
- 15 Aug 2019
- Results posted
- Yes, on ClinicalTrials.gov
Publications
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.
PubMed 33724104Ferro 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.
PubMed 32972315Ferro 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.
PubMed 31479105Ferro 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.
PubMed 29775170
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02913326
- Acronym / sponsor ID
- 1160.248
- Conditions
- Thromboembolism
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- 13 Dec 2016 (actual)
- Primary completion
- 22 Jun 2018 (actual)
- Study completion
- 22 Jun 2018 (actual)
- First posted
- 23 Sep 2016 (estimated)
- Results
- Posted 15 Aug 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dabigatran etexilate | Experimental | Drug: Dabigatran etexilate |
| Warfarin | Active comparator | Drug: Warfarin |
Who may qualify
- Ages
- 18 to 78 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dabigatran etexilate | Drug | Dabigatran etexilate |
| Warfarin | Drug | Warfarin |
Primary outcome
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
7 secondary outcomes
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.
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
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.
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.
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.
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 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33724104Ferro 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.
- Derived from this study: PubMed 32972315Ferro 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.
- Derived from this study: PubMed 31479105Ferro 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.
- Derived from this study: PubMed 29775170Ferro 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.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Boehringer Ingelheim study chair
Boehringer Ingelheim
36 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Dabigatran etexilate and Warfarin in people with Thromboembolism, run by Boehringer Ingelheim at 36 sites in 9 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 36 sites in India, Italy, Germany, Portugal, Poland and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Aug 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: From first administration of trial medication until 6 days after last administration of trial medication, up to 25 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02913326, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2019.