Stroke, IschemicPhase 2NCT05189509
EXtending the tIme Window of Thrombolysis by ButyphThalide up to 6 Hours After Onset (EXIT-BT)
A Phase 2 study testing TNK-Tissue Plasminogen Activator in people with Stroke, Ischemic, run by General Hospital of Shenyang Military Region at 1 site in China.
Trial summary
To date, the time window of intravenous thrombolysis is limited within 4.5 hours of stroke onset. Although EXTEND study has proved that intravenous thrombolysis can be extended from 4.5 to 9 hours, but the eligible patients must be selected by CTP. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Stroke, Ischemic
- What is being tested?
- TNK-Tissue Plasminogen Activator
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 11 Feb 2022to 28 Dec 2022
- Phase
- Phase 2
- 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
- age: 18-80;
- ischemic stroke confirmed by brain CT or MRI
- the time from onset to treatment: 4.5-6 hours
- NIHSS≥4
- prestroke mRS≤1
- signed informed consent
Who cannot join
- prestroke mRS≥2
- planned endovascular treatment
- planned intravenous thrombolysis based on WAKE-UP or EXTEND study criterion
- any contraindiction of intravenous thrombolysis
- other unsuitable conditions judged by investigator
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Neurology, General Hospital of Northern Theater Command
Shenyang, 110016
About this study
Official title: EXtending the tIme Window of Thrombolysis by ButyphThalide up to 6 Hours After Onset (EXIT-BT): a Prospective, Randomized, Blinded Assessment of Outcome and Open Label Multi-center Study
To date, the time window of intravenous thrombolysis is limited within 4.5 hours of stroke onset. Although EXTEND study has proved that intravenous thrombolysis can be extended from 4.5 to 9 hours, but the eligible patients must be selected by CTP. Thus, it is of clinical importance how to extend the time window of intravenous thrombolysis, which can benifit more patients. The current trial aims to investigate the effect of intravenous thrombolysis with TNK from 4.5 to 6 hours in ischemic stroke with help of Butyphthalide, which was found to be neuroprotective.
- Conditions
- Stroke, Ischemic
- Being tested
- TNK-Tissue Plasminogen Activator
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TNK-Tissue Plasminogen ActivatorDrug
0.25 mg TNK thrombolysis
| Study group | Role | What they receive |
|---|---|---|
| TNK group | Experimental | intravenous thrombolysis with 0.25 mg/kg TNK, with the biggest dose of 25 mg Receives: Drug: TNK-Tissue Plasminogen Activator |
| control group | Placebo comparator | Not described Receives: Drug: TNK-Tissue Plasminogen Activator |
What is being measured
The primary outcome is the main question the study is designed to answer.
symptomatic intracerebral hemorrhage
any evidence of bleeding on the head CT scan associated with clinically significant neurological deterioration (NIHSS score ≥4 points increase)
Measured: 36 hours
Secondary outcomes (8)
The proportion of excellent prognosis (mRS 0-1)
the minimum and maximum values of modified Rankin Score are 0 and 6, respectively; higher score mean a worse outcome
Measured: Day 90
The proportion of favourable prognosis (mRS 0-2)
the minimum and maximum values of modified Rankin Score are 0 and 6, respectively; higher score mean a worse outcome
Measured: Day 90
Distribution of modified Rankin Score
the minimum and maximum values of modified Rankin Score are 0 and 6, respectively; higher score mean a worse outcome
Measured: Day 90
Changes in National Institute of Health stroke scale (NIHSS)
the minimum and maximum values of NIHSS are 0 and 42, respectively; higher NIHSS mean a worse outcome
Measured: 24 hours, 2 weeks
any intracerebral hemorrhage
the evidence of bleeding on the head CT scan
Measured: 36 hours
any cerebral microbleeding(CMB)
CMB is measured by SWI sequence
Measured: 48 hours
infarct volume
infarct volume is measured by DWI sequence
Measured: 48 hours
proportion of death
death due to any cause
Measured: Day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2022
- Study start11 Feb 2022
- Primary completion30 Sep 2022
- Study completion28 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Stroke, IschemicStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- General Hospital of Shenyang Military Region
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hui-Sheng Chen, General Hospital of Shenyang Military Region
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05189509
- Sponsor's protocol ID
- y (2021) 110
- Status last verified
- Jan 2023
- First submitted
- 29 Dec 2021
- Last updated
- 13 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chen HS, Chen MR, Cui Y, Shen XY, Zhang H, Lu J, Zhao LW, Duan YJ, Li J, Wang YM, Min LQ, Zhao LH, Wan LS, Zhang ZH, Nguyen TN. Tenecteplase Plus Butyphthalide for Stroke Within 4.5-6 Hours of Onset (EXIT-BT): a Phase 2 Study. Transl Stroke Res. 2025 Jun;16(3):575-583. doi: 10.1007/s12975-024-01231-2. Epub 2024 Jan 19.
PubMed 38238620
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EXtending the tIme Window of Thrombolysis by ButyphThalide up to 6 Hours After Onset (EXIT-BT): a Prospective, Randomized, Blinded Assessment of Outcome and Open Label Multi-center Study
- ClinicalTrials.gov ID
- NCT05189509
- Acronym / sponsor ID
- y (2021) 110
- Conditions
- Stroke, Ischemic
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- General Hospital of Shenyang Military RegionUniversity, hospital or other
- Study start
- 11 Feb 2022 (actual)
- Primary completion
- 30 Sep 2022 (actual)
- Study completion
- 28 Dec 2022 (actual)
- First posted
- 12 Jan 2022 (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.
To date, the time window of intravenous thrombolysis is limited within 4.5 hours of stroke onset. Although EXTEND study has proved that intravenous thrombolysis can be extended from 4.5 to 9 hours, but the eligible patients must be selected by CTP. Thus, it is of clinical importance how to extend the time window of intravenous thrombolysis, which can benifit more patients. The current trial aims to investigate the effect of intravenous thrombolysis with TNK from 4.5 to 6 hours in ischemic stroke with help of Butyphthalide, which was found to be neuroprotective.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TNK group | Experimental | Drug: TNK-Tissue Plasminogen Activatorintravenous thrombolysis with 0.25 mg/kg TNK, with the biggest dose of 25 mg |
| control group | Placebo comparator | Drug: TNK-Tissue Plasminogen Activator |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- age: 18-80;
- ischemic stroke confirmed by brain CT or MRI
- the time from onset to treatment: 4.5-6 hours
- NIHSS≥4
- prestroke mRS≤1
Key exclusion criteria (5 listed)
- prestroke mRS≥2
- planned endovascular treatment
- planned intravenous thrombolysis based on WAKE-UP or EXTEND study criterion
- any contraindiction of intravenous thrombolysis
- other unsuitable conditions judged by investigator
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 |
|---|---|---|
| TNK-Tissue Plasminogen Activator0.25 mg TNK thrombolysis | Drug | TNK group, control group |
Primary outcome
symptomatic intracerebral hemorrhage
Time frame: 36 hours
any evidence of bleeding on the head CT scan associated with clinically significant neurological deterioration (NIHSS score ≥4 points increase)
8 secondary outcomes
The proportion of excellent prognosis (mRS 0-1)
Time frame: Day 90
The proportion of favourable prognosis (mRS 0-2)
Time frame: Day 90
Distribution of modified Rankin Score
Time frame: Day 90
Changes in National Institute of Health stroke scale (NIHSS)
Time frame: 24 hours, 2 weeks
any intracerebral hemorrhage
Time frame: 36 hours
any cerebral microbleeding(CMB)
Time frame: 48 hours
infarct volume
Time frame: 48 hours
proportion of death
Time frame: Day 90
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2023.
- Derived from this study: PubMed 38238620Chen HS, Chen MR, Cui Y, Shen XY, Zhang H, Lu J, Zhao LW, Duan YJ, Li J, Wang YM, Min LQ, Zhao LH, Wan LS, Zhang ZH, Nguyen TN. Tenecteplase Plus Butyphthalide for Stroke Within 4.5-6 Hours of Onset (EXIT-BT): a Phase 2 Study. Transl Stroke Res. 2025 Jun;16(3):575-583. doi: 10.1007/s12975-024-01231-2. Epub 2024 Jan 19.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing TNK-Tissue Plasminogen Activator in people with Stroke, Ischemic, run by General Hospital of Shenyang Military Region at 1 site in China.
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 6 inclusion and 5 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 13 Jan 2023. 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 China. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
symptomatic intracerebral hemorrhage (time frame: 36 hours). 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 NCT05189509, which also lists 1 linked publication.
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 13 Jan 2023.