Stroke, IschemicPhase 3NCT05657444
Intra-arterial Tenecteplase During First Thrombectomy Attempt for Acute Stroke (BRETIS-TNK II)
A Phase 3 study testing Tenecteplase in people with Stroke, Ischemic, run by General Hospital of Shenyang Military Region at 1 site in China.
Trial summary
A recent pilot study suggests intra-arterial tenecteplase (TNK) during the first pass of endovascular treatment (EVT) seems safe, may increase first-pass reperfusion and good outcome in acute ischemic stroke (AIS) patients with large vessel occlusion (LVO). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Ischemic
- What is being tested?
- Tenecteplase
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 380 participants
- Where
- 1 siteChina
- Study dates
- 21 Mar 2023to 20 Mar 2025
- Phase
- Phase 3
- 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
Who may be able to join
- Age ≥18 years;
- Stroke patient with large vessel occlusion (internal carotid artery, M1 or M2 of middle cerebral artery, basilar artery, or intracranial segment of vertebral artery) who meets criteria for endovascular treatment within 24 hours of stroke onset;
- The modified Rankin Scale (mRS) score before onset ≤ 2;
- ASPECTS 6 or greater on CT
- Signed informed consent.
Who cannot join
- hemorrhagic stroke;
- Tandem occlusion;
- Coagulation disorders, systematic hemorrhagic tendency, thrombocytopenia (<100000/mm3);
- Severe hepatic or renal dysfunction, increase in ALT or AST (more than 2 times of upper limit of normal value), elevated serum creatinine (more than 1.5 times of upper limit of normal value) or requiring dialysis;
- Severe uncontrolled hypertension (systolic blood pressure over 200mmHg or diastolic blood pressure over 110 mmHg);
- Patients with contraindication or allergic to any ingredient of drugs in our study;
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- Pregnancy, or plan to get pregnant or during active lactation;
- Suspected septic embolus or infective endocarditis
- The estimated life expectancy is less than 6 months due to other serious diseases;
- Other conditions unsuitable for this clinical study as assessed by researcher.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Intra-arterial Tenecteplase During First Thrombectomy Attempt for Acute Stroke (BRETIS-TNK II): a Prospective, Randomized, Adaptive Enrichment, Open-label, Blinded End Point, Multi-center Study
A recent pilot study suggests intra-arterial tenecteplase (TNK) during the first pass of endovascular treatment (EVT) seems safe, may increase first-pass reperfusion and good outcome in acute ischemic stroke (AIS) patients with large vessel occlusion (LVO).
The study aimed to determine the efficacy and safety of intra-arterial TNK administration during EVT in AIS-LVO patients.
- Conditions
- Stroke, Ischemic
- Being tested
- Tenecteplase
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TenecteplaseDrug
intra-arterial tenecteplase during endovascular treatment
| Study group | Role | What they receive |
|---|---|---|
| TNK group | Experimental | Not described Receives: Drug: Tenecteplase |
| control group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
proportion of favorable outcome
Favorable outcome is defined as modified Rankin Scale (mRS) score of 0-2
Measured: Day 90
Secondary outcomes (14)
proportion of excellent outcome
Excellent outcome is defined as modified Rankin Scale (mRS) score of 0-1
Measured: Day 90
proportion of successful reperfusion after the first-pass or final pass of endovascular treatment
Successful reperfusion is defined as defined as modified Thrombolysis In Cerebral Infarction (mTICI) 2b-3
Measured: immediately after the first-pass or final pass of endovascular treatment
Distribution of modified Rankin Scale (mRS)
mRS scores range from 0 to 6:0, no symptoms, 1 = symptoms without clinically significant disability, 2 = slight disability, 3 = moderate disability, 4 = moderately severe disability, 5 = severe disability; and 6 = death.
Measured: Day 90
Change in cerebral circulation time after intervention
Measured: immediately after endovascular treatment
occurrence rate of early neurological improvement
early neurological improvement was defined as a 4 point or greater decrease in NIHSS
Measured: 24 (-6/+24) hours
change in National Institute of Health stroke scale (NIHSS)
NIHSS scores range 0-42, with higher scores indicating greater stroke severity
Measured: 24 (-6/+24) hours
occurrence rate of the composite events of nonfatal stroke, nonfatal myocardial infarction, and other cardiovascular events
Measured: Day 90
occurrence rate of symptomatic intracranial hemorrhage
symptomatic intracranial hemorrhage is defined as an increase in the NIHSS score of ≥4 points as a result of the intracranial hemorrhage.
Measured: 24 (-6/+24) hours
occurrence rate of parenchymal hemorrhage
parenchymal hemorrhage was defined as confluent bleeding occupying and causing mass effect
Measured: 24 (-6/+24) hours
percentage of severe adverse events
Measured: 24 (-6/+24) hours
cerebral edema
cerebral edema was measured as the amount of midline shift of the brain on neuroimaging
Measured: 24 (-6/+24) hours
death due to all causes
Measured: Day 7 or during hospitalization
occurrence rate of the distal emboli after first pass
The emboli means occlusion of the distal artery determined by DSA.
Measured: immediately after first pass
occurrence rate of extracranial hemorrhage
extracranial hemorrhage means other bleeding events except intracranial hemorrhage
Measured: 24 (-6/+24) hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2022
- Study start21 Mar 2023
- Primary completion20 Mar 2025
- Study completion20 Mar 2025
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.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 380 participants (actual)
Sponsor and investigators
- Lead sponsor
- General Hospital of Shenyang Military Region
- Sponsor type
- University, hospital or other
- Collaborators
- Cerebrovascular Disease Collaboration & Innovation Alliance of Liaoning
- Responsible party
- Principal investigator, Hui-Sheng Chen, General Hospital of Shenyang Military Region
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05657444
- Sponsor's protocol ID
- Y (2022) 168
- Status last verified
- Mar 2025
- First submitted
- 2 Dec 2022
- Last updated
- 28 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 28 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intra-arterial Tenecteplase During First Thrombectomy Attempt for Acute Stroke (BRETIS-TNK II): a Prospective, Randomized, Adaptive Enrichment, Open-label, Blinded End Point, Multi-center Study
- ClinicalTrials.gov ID
- NCT05657444
- Acronym / sponsor ID
- Y (2022) 168
- Conditions
- Stroke, Ischemic
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 380 participants (actual)
- Lead sponsor
- General Hospital of Shenyang Military RegionUniversity, hospital or other
- Collaborators
- Cerebrovascular Disease Collaboration & Innovation Alliance of Liaoning
- Study start
- 21 Mar 2023 (actual)
- Primary completion
- 20 Mar 2025 (actual)
- Study completion
- 20 Mar 2025 (actual)
- First posted
- 20 Dec 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.
A recent pilot study suggests intra-arterial tenecteplase (TNK) during the first pass of endovascular treatment (EVT) seems safe, may increase first-pass reperfusion and good outcome in acute ischemic stroke (AIS) patients with large vessel occlusion (LVO).
The study aimed to determine the efficacy and safety of intra-arterial TNK administration during EVT in AIS-LVO patients.
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: Tenecteplase |
| control group | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥18 years;
- Stroke patient with large vessel occlusion (internal carotid artery, M1 or M2 of middle cerebral artery, basilar artery, or intracranial segment of vertebral artery) who meets criteria for endovascular treatment within 24 hours of stroke onset;
- The modified Rankin Scale (mRS) score before onset ≤ 2;
- ASPECTS 6 or greater on CT
- Signed informed consent.
Key exclusion criteria (10 listed)
- hemorrhagic stroke;
- Tandem occlusion;
- Coagulation disorders, systematic hemorrhagic tendency, thrombocytopenia (<100000/mm3);
- Severe hepatic or renal dysfunction, increase in ALT or AST (more than 2 times of upper limit of normal value), elevated serum creatinine (more than 1.5 times of upper limit of normal value) or requiring dialysis;
- Severe uncontrolled hypertension (systolic blood pressure over 200mmHg or diastolic blood pressure over 110 mmHg);
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 |
|---|---|---|
| Tenecteplaseintra-arterial tenecteplase during endovascular treatment | Drug | TNK group |
Primary outcome
proportion of favorable outcome
Time frame: Day 90
Favorable outcome is defined as modified Rankin Scale (mRS) score of 0-2
14 secondary outcomes
proportion of excellent outcome
Time frame: Day 90
proportion of successful reperfusion after the first-pass or final pass of endovascular treatment
Time frame: immediately after the first-pass or final pass of endovascular treatment
Distribution of modified Rankin Scale (mRS)
Time frame: Day 90
Change in cerebral circulation time after intervention
Time frame: immediately after endovascular treatment
occurrence rate of early neurological improvement
Time frame: 24 (-6/+24) hours
change in National Institute of Health stroke scale (NIHSS)
Time frame: 24 (-6/+24) hours
occurrence rate of the composite events of nonfatal stroke, nonfatal myocardial infarction, and other cardiovascular events
Time frame: Day 90
occurrence rate of symptomatic intracranial hemorrhage
Time frame: 24 (-6/+24) hours
occurrence rate of parenchymal hemorrhage
Time frame: 24 (-6/+24) hours
percentage of severe adverse events
Time frame: 24 (-6/+24) hours
cerebral edema
Time frame: 24 (-6/+24) hours
death due to all causes
Time frame: Day 7 or during hospitalization
occurrence rate of the distal emboli after first pass
Time frame: immediately after first pass
occurrence rate of extracranial hemorrhage
Time frame: 24 (-6/+24) hours
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 28 Mar 2025.
- 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.
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 3 study testing Tenecteplase 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 5 inclusion and 10 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 28 Mar 2025. 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. 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?
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?
proportion of favorable outcome (time frame: Day 90). 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 28 Mar 2025.