Stroke, AcuteRARETBASNCT04177615
Randomized Assessment of Rapid Endovascular Treatment in Basilar Artery Occlusion Stroke in 115 Hospital
A study testing Thromboectomy in people with Stroke, Acute and Basilar Artery Occlusion, run by University of Medicine and Pharmacy at Ho Chi Minh City.
Trial summary
This is a prospective, open lable studies conducted in 115 hospital to compare between thromboectomy and Recombinant Tisue Plasminogen Activator only to evaluate the eficacy and safety of endovascular treatment in basilar artery occlusion stroke patients Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Stroke, Acute, Basilar Artery Occlusion
- What is being tested?
- Thromboectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 109 participants
- Where
- No sites listed yet
- Study dates
- 19 Nov 2019to 30 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients admit to 115 hospital in 24h of Basilar Artery Occlusion Stroke
- NIHSS > 4 points
Who cannot join
- Patients refuse to participate in studies
- Patients with contraindication of either rTPA or thromboectomy
Trial locations and contacts
No sites are listed yet.
THANG H Nguyen, MD, PhD contact
About this study
This is a prospective, open lable studies conducted in 115 hospital to compare between thromboectomy and Recombinant Tisue Plasminogen Activator only to evaluate the eficacy and safety of endovascular treatment in basilar artery occlusion stroke patients
Read the detailed description
Acute basilar artery thrombosis is associated with a poor prognosis. Prevalence of basilar artery occlusion are not known. Although basilar artery occlusion has been reported in 2 per 1000 autopsy cases, basilar artery thrombosis may, in stroke registries, explain as many as 27% of ischemic strokes occurring in the posterior circulation.Various treatments were tried in groups of patients with vertebrobasilar territory infarction but evidence based was not cleared previous studies. Therefore, we conduct this study to evaluate the eficacy and safety of endovascular treatment in basilar artery occlusion stroke patients
- Conditions
- Stroke, Acute, Basilar Artery Occlusion
- Being tested
- Thromboectomy
- Keywords
- Ischemic stroke, Basilar Artery Occlusion
- Medical subject headings
- Stroke, Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ThromboectomyProcedure or surgery
Thromboectomy in Basilar Artery Occlusion patients
| Study group | Role | What they receive |
|---|---|---|
| Thromboectomy and rTPA | Experimental | use thromboectomy and rtpa for patient with basilar artery occlusion stroke in 24 hour Receives: Procedure: Thromboectomy |
| rTPA( recombinant tissue plasminogen activator ) | No intervention | use rtpa for patient with basilar artery occlusion stroke in 24 hour |
What is being measured
The primary outcome is the main question the study is designed to answer.
NIHSS in patients wtih Basilar Artery Occlusion Stroke after 24hour admission
NIHSS in patients wtih Basilar Artery Occlusion Stroke after 24hour admission
Measured: 24 hours from admission
Survival rate in patients with Basilar Artery Occlusion Stroke
Survival rate in patients with Basilar Artery Occlusion Stroke
Measured: 3 months from admission
Secondary outcomes (1)
mRS in patients with Basilar Artery Occlusion Stroke
mRS in patients with Basilar Artery Occlusion Stroke
Measured: 3 months from admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2019
- Study start19 Nov 2019 (estimated)
- Primary completion19 Nov 2020 (estimated)
- Study completion30 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke, AcuteStudies of the same condition, open and under way.
- More trials run by University of Medicine and Pharmacy at Ho Chi Minh CityThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 109 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tran Nguyen Uyen Dung, University of Medicine and Pharmacy at Ho Chi Minh City
- Investigators
- TUAN D Tran, MD, Study chair, UMP university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04177615
- Sponsor's protocol ID
- yds2019
- Acronym
- RARETBAS
- Status last verified
- Nov 2019
- First submitted
- 24 Nov 2019
- Last updated
- 26 Nov 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Assessment of Rapid Endovascular Treatment in Basilar Artery Occlusion Stroke in 115 Hospital
- ClinicalTrials.gov ID
- NCT04177615
- Acronym / sponsor ID
- RARETBAS / yds2019
- Conditions
- Stroke, Acute, Basilar Artery Occlusion
- Keywords
- Ischemic stroke, Basilar Artery Occlusion
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 109 participants (estimated)
- Lead sponsor
- University of Medicine and Pharmacy at Ho Chi Minh CityUniversity, hospital or other
- Study start
- 19 Nov 2019 (estimated)
- Primary completion
- 19 Nov 2020 (estimated)
- Study completion
- 30 Dec 2020 (estimated)
- First posted
- 26 Nov 2019 (actual)
- Results
- Not posted in the source record
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 prospective, open lable studies conducted in 115 hospital to compare between thromboectomy and Recombinant Tisue Plasminogen Activator only to evaluate the eficacy and safety of endovascular treatment in basilar artery occlusion stroke patients
Detailed description
Acute basilar artery thrombosis is associated with a poor prognosis. Prevalence of basilar artery occlusion are not known. Although basilar artery occlusion has been reported in 2 per 1000 autopsy cases, basilar artery thrombosis may, in stroke registries, explain as many as 27% of ischemic strokes occurring in the posterior circulation.Various treatments were tried in groups of patients with vertebrobasilar territory infarction but evidence based was not cleared previous studies. Therefore, we conduct this study to evaluate the eficacy and safety of endovascular treatment in basilar artery occlusion stroke patients
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Thromboectomy and rTPA | Experimental | Procedure: Thromboectomyuse thromboectomy and rtpa for patient with basilar artery occlusion stroke in 24 hour |
| rTPA( recombinant tissue plasminogen activator ) | No intervention | –use rtpa for patient with basilar artery occlusion stroke in 24 hour |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients admit to 115 hospital in 24h of Basilar Artery Occlusion Stroke
- NIHSS > 4 points
Key exclusion criteria (2 listed)
- Patients refuse to participate in studies
- Patients with contraindication of either rTPA or thromboectomy
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 |
|---|---|---|
| ThromboectomyThromboectomy in Basilar Artery Occlusion patients | Procedure or surgery | Thromboectomy and rTPA |
Primary outcome
NIHSS in patients wtih Basilar Artery Occlusion Stroke after 24hour admission
Time frame: 24 hours from admission
NIHSS in patients wtih Basilar Artery Occlusion Stroke after 24hour admission
Survival rate in patients with Basilar Artery Occlusion Stroke
Time frame: 3 months from admission
Survival rate in patients with Basilar Artery Occlusion Stroke
1 secondary outcome
mRS in patients with Basilar Artery Occlusion Stroke
Time frame: 3 months from admission
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2019.
- Individual participant dataSharing planned: No
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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.
THANG H Nguyen, MD, PhD contact
TUAN D Tran, MD study chair
UMP university
Questions about this trial
What is this clinical trial studying?
A study testing Thromboectomy in people with Stroke, Acute and Basilar Artery Occlusion, run by University of Medicine and Pharmacy at Ho Chi Minh City.
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 2 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 26 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact DUNG U Tran Nguyen (0902610832, uyendungtrannguyen@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
NIHSS in patients wtih Basilar Artery Occlusion Stroke after 24hour admission (time frame: 24 hours from admission). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Nov 2019.