Stroke, IschemicNCT04170647
Efficacy of Intravenous Tissue-type Plasminogen Activator on Acute Ischemic Stroke Patients With Large Vessel Occlusions
An observational study of Stroke, Ischemic and Stroke, Acute, run by University of Medicine and Pharmacy at Ho Chi Minh City at 1 site in Vietnam.
Trial summary
This is an observational prospective study about the reperfusion rate of intravenous thrombolysis on ischemic stroke patients with large vessel occlusions and predictor factors of successful recanalization. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Ischemic, Stroke, Acute
- What is being tested?
- Plasminogen Activators
- Type of treatment
- Injection or infusion
- How many people
- 81 participants
- Where
- 1 siteVietnam
- Study dates
- 1 Oct 2017to 1 Jan 2020
- How long will I take part?
- 7 Days
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Acute ischemic stroke patients presented at our hospital with LVO confirmed who received both intravenous tissue-type plasminogen activator and subsequent repeat angiography will be included in our study.
Who may be able to join
- Age 18 and older with consent form signed.
- Patients hospitalized in 115 People's Hospital for acute ischemic stroke.
- Patients receiving full dose of IVT, with a confirmed LVO (including MCA M1, MCA M2, ICA, BA and VA) on angiography and repeat vascular imaging within 24 hours of hospitalization.
Who cannot join
- Patients with evidence of chronic occlusion of large vessels.
- Patients without source angiography data to assess the characteristics of thrombus
Trial locations and contacts
1 site in 1 country.
Vietnam1 site, 1 recruiting
- Recruiting
115 People's Hospital
Ho Chi Minh City, 700000
THANG Nguyen Huy, MD, PhD, 0084 783629422
About this study
Official title: Reperfusion Rates of Intravenous Tissue-type Plasminogen Activator on Acute Ischemic Stroke Patients With Large Vessel Occlusions and Predictor Factors of Recanalization
This is an observational prospective study about the reperfusion rate of intravenous thrombolysis on ischemic stroke patients with large vessel occlusions and predictor factors of successful recanalization.
Read the detailed description
Stroke is one the most common cause of mortality and disabilities in the world, with the highest incidence in East Asia. Current American Stroke Association (ASA) and European Stroke Organisation (ESO) guidelines recommend bridging therapy with IVT for all eligible patients before indicating endovascular thrombectomy (EVT) for those with large vessel occlusions (LVO). Nevertheless, the decision to use IVT on stroke patients with LVO is still debatable, with many arguments against and supporting combined therapy or direct mechanical thrombectomy. At present, guideline in our hospital advocates the use of IVT in all patients who meet eligibility criteria and present within the 4,5 hour window for anterior circulation stroke and within 24 hour window for posterior circulation stroke. Due to the overcrowded nature of our center as a high-end specialization establishment in Vietnam, it is noted that our door-to-groin time is sub-optimal. This fact inadvertently prolongs the time of action of intravenous tissue-type plasminogen activator before the re-assessment of occlusion site on interventional radiography. Therefore, it is possible for us to better estimate the reperfusion effectiveness of IVT as well as analyse other factors that might have an influence on this rate. The goal of our study is to determine the recanalization rate of IVT and related predictor factors in AIS patients.
- Conditions
- Stroke, Ischemic, Stroke, Acute
- Being tested
- Plasminogen Activators
- Keywords
- reperfusion, IVT
- Medical subject headings
- Ischemic Stroke, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Plasminogen ActivatorsDrug
standard dosage of 0.9 mg/kg or reduced dosage of 0.6 mg/kg, divided into a 15% bolus and an 85% venous infusion
What is being measured
The primary outcome is the main question the study is designed to answer.
reperfusion rate
the reperfusion rate of intravenous thrombolysis in acute ischemic stroke with large vessel occlusion first confirmed by angiography and assessed later by a vascular imaging modality.
Measured: within 24 hours of hospitalization
Secondary outcomes (1)
symptomatic intracerebral hemorrhage
incidence of symptomatic intracerebral hemorrhage 48 hours after initiation of IVT
Measured: 48 hours after initiation of IVT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2019
- Study start1 Oct 2017
- Primary completion1 Jan 2020 (estimated)
- Study completion1 Jan 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke, IschemicStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 81 participants (estimated)
- Target duration
- 7 Days
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tinh Quang DANG, University of Medicine and Pharmacy at Ho Chi Minh City
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04170647
- Sponsor's protocol ID
- UMP11192019
- Status last verified
- Nov 2019
- First submitted
- 18 Nov 2019
- Last updated
- 20 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reperfusion Rates of Intravenous Tissue-type Plasminogen Activator on Acute Ischemic Stroke Patients With Large Vessel Occlusions and Predictor Factors of Recanalization
- ClinicalTrials.gov ID
- NCT04170647
- Acronym / sponsor ID
- UMP11192019
- Conditions
- Stroke, Ischemic, Stroke, Acute
- Keywords
- reperfusion, IVT
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 81 participants (estimated)
- Lead sponsor
- University of Medicine and Pharmacy at Ho Chi Minh CityUniversity, hospital or other
- Study start
- 1 Oct 2017 (actual)
- Primary completion
- 1 Jan 2020 (estimated)
- Study completion
- 1 Jan 2020 (estimated)
- First posted
- 20 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 an observational prospective study about the reperfusion rate of intravenous thrombolysis on ischemic stroke patients with large vessel occlusions and predictor factors of successful recanalization.
Detailed description
Stroke is one the most common cause of mortality and disabilities in the world, with the highest incidence in East Asia. Current American Stroke Association (ASA) and European Stroke Organisation (ESO) guidelines recommend bridging therapy with IVT for all eligible patients before indicating endovascular thrombectomy (EVT) for those with large vessel occlusions (LVO). Nevertheless, the decision to use IVT on stroke patients with LVO is still debatable, with many arguments against and supporting combined therapy or direct mechanical thrombectomy. At present, guideline in our hospital advocates the use of IVT in all patients who meet eligibility criteria and present within the 4,5 hour window for anterior circulation stroke and within 24 hour window for posterior circulation stroke. Due to the overcrowded nature of our center as a high-end specialization establishment in Vietnam, it is noted that our door-to-groin time is sub-optimal. This fact inadvertently prolongs the time of action of intravenous tissue-type plasminogen activator before the re-assessment of occlusion site on interventional radiography. Therefore, it is possible for us to better estimate the reperfusion effectiveness of IVT as well as analyse other factors that might have an influence on this rate. The goal of our study is to determine the recanalization rate of IVT and related predictor factors in AIS patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 7 Days
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Acute ischemic stroke patients presented at our hospital with LVO confirmed who received both intravenous tissue-type plasminogen activator and subsequent repeat angiography will be included in our study.
Key inclusion criteria (3 listed)
- Age 18 and older with consent form signed.
- Patients hospitalized in 115 People's Hospital for acute ischemic stroke.
- Patients receiving full dose of IVT, with a confirmed LVO (including MCA M1, MCA M2, ICA, BA and VA) on angiography and repeat vascular imaging within 24 hours of hospitalization.
Key exclusion criteria (2 listed)
- Patients with evidence of chronic occlusion of large vessels.
- Patients without source angiography data to assess the characteristics of thrombus
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 |
|---|---|---|
| Plasminogen Activatorsstandard dosage of 0.9 mg/kg or reduced dosage of 0.6 mg/kg, divided into a 15% bolus and an 85% venous infusion | Drug | – |
Primary outcome
reperfusion rate
Time frame: within 24 hours of hospitalization
the reperfusion rate of intravenous thrombolysis in acute ischemic stroke with large vessel occlusion first confirmed by angiography and assessed later by a vascular imaging modality.
1 secondary outcome
symptomatic intracerebral hemorrhage
Time frame: 48 hours after initiation of IVT
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2019.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke, Ischemic and Stroke, Acute, run by University of Medicine and Pharmacy at Ho Chi Minh City at 1 site in Vietnam.
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 3 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 20 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Vietnam. 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.
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 TINH Dang Quang, MD (0084 783629421, tinh942008@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
reperfusion rate (time frame: within 24 hours of hospitalization). 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 20 Nov 2019.