Acute Ischemic StrokeNCT06559436
Extending the Time Window for Intravenous Tenecteplase in Patients With Distal Medium Vessel Occlusions Stroke
A study testing Intravenous thrombolysis and Standard medical management in people with Acute Ischemic Stroke, run by The First Affiliated Hospital of University of Science and Technology of China at 1 site in China.
Trial summary
To assess the safety and efficacy of beyond time window TNK intravenous thrombolysis for distal Medium Vessel Occlusion (MeVO) related stroke in a prospective randomized clinical trial. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Ischemic Stroke
- What is being tested?
- Intravenous thrombolysis and Standard medical management
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 560 participants
- Where
- 1 siteChina
- Study dates
- 2 Oct 2024to 1 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Evidence of a primary (e.g., not secondary to endovascular therapy of proximal vessel occlusion) distal medium vascular occlusion defined as occlusion of the co/non-dominant M2 segment*, M3, or M4 segment of the middle cerebral artery (MCA), the anterior cerebral artery (ACA) (A1, A2, A3, or A4 segments), or the posterior cerebral artery (PCA) (P1, P2, P3, or P4 segments);
- Co/non-dominant M2 segment vessel diameter should not exceed 2.0 mm. Co-dominant supplying 50% of the MCA territory vs non-dominant supplying <50% of the MCA territory.
- Age ≥18 years;
- Premorbid mRS 0-1;
- Evidence of a disabling stroke defined as follows:
- Baseline National Institutes of Health Stroke Scale (NIHSS) score ≥4 at the time of randomization.
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- NIHSS 2-3 with disabling deficit including significant aphasia, neglect, hemianopsia, or hemiparesis/ loss of hand or leg function as established by the treating team in context of the patient's life.
- Less than 50% core in the territory supplied by the occluded vessel as evident by hypodensity and loss of grey-white border on NCCT or ADC <620 mm2/s on diffusion MRI or rCBF<30% on CTP after 6h of symptom onset.
- Time from onset (or time last seen well) to treatment within 4.5-24 hours;
- Informed consent obtained from patient or acceptable patient surrogate.
Who cannot join
- Received intravenous thrombolysis prior to randomization;
- Allergy to Tenecteplase;
- Seizures, or other neurological/mental illness at stroke onset if it precludes obtaining an accurate baseline NIHSS;
- Patients planned to undergo MT or other endovascular treatments (e.g., intra-arterial thrombolysis);
- Systolic blood pressure>185 mmHg or diastolic blood pressure>110 mmHg, which cannot be controlled by antihypertensive drug(s);
- Acute intracerebral hemorrhage identified by CT or MRI;
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- Clinical presentation suggests a subarachnoid hemorrhage, even if initial CT or MRI scan is normal;
- Subjects with occlusions in multiple vascular territories (e.g., bilateral or multi-territorial anterior circulation, or anterior/posterior circulation);
- Contraindication to imaging with MR or CT with contrast agents;
- Known genetic or acquired bleeding diathesis, or received warfarin and INR > 1.7; or treated with direct oral anticoagulant agents in the prior 48 hours;
- Platelets <100×109/L, APTT > 40 s, or PT >15 s; Blood glucose <50 mg/dl (2.7 mmol/L) or >400 mg/dl (22.2 mmol/L);
- Severe renal failure, defined as serum creatinine > 3.0 mg/dl (or 265.2 μmol/l) or glomerular filtration rate (GFR) < 30, or patients requiring hemodialysis or peritoneal dialysis;
- Active internal hemorrhage or at high risk of bleeding, e.g., major surgery, sever trauma or gastrointestinal or urinary tract hemorrhage within the last 2 weeks, or arterial puncture at a non-compressible site within the previous 7 days;
- Ischemic stroke or myocardial infarction in previous 3 months, previous intracranial hemorrhage, severe traumatic brain injury or intracranial or intraspinal operation in previous 3 months, or known intracranial neoplasm, arteriovenous malformation or giant aneurysm;
- Life expectancy < 1 year;
- Patients who cannot adhere to the trial protocol or follow-up;
- Currently participating in other clinical trials;
- Pregnant or lactating women;
- Any other condition that, in the opinion of the investigator, could impose hazards to the patient if study therapy is initiated or affect the participation of the patient in the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of University of Science and Technology of China
Hefei, Anhui
Wei Hu, MD,PhD, +8615155510611, andinghu@ustc.edu.cn
About this study
Official title: Extending the Time Window for Intravenous Tenecteplase in Patients With Distal Medium Vessel Occlusions Stroke-a Randomised, Controlled, Multicentre Study
To assess the safety and efficacy of beyond time window TNK intravenous thrombolysis for distal Medium Vessel Occlusion (MeVO) related stroke in a prospective randomized clinical trial.
Read the detailed description
Previous study has confirmed that in acute ischemic stroke patients with large vessel occlusion within 4.5-24 hours of symptom onset and a salvageable penumbra on perfusion imaging, TNK thrombolysis is safe and can significantly improve the prognosis in the absence of mechanical thrombectomy. However, it is currently unknown whether TNK intravenous thrombolysis beyond optimal time window can improve the prognosis of distal Medium Vessel Occlusion (MeVO) related patients.
- Conditions
- Acute Ischemic Stroke
- Being tested
- Intravenous thrombolysis, Standard medical management
- Keywords
- Medium Vessel Occlusion, Stroke Due To Medium Vessel Occlusion, Beyond optimal time window, TNK intravenous thrombolysis
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravenous thrombolysisDrug
Patients in the TNK treatment group will receive TNK intravenous thrombolysis after MeVO is determined, and the usual dosage for TNK intravenous thrombolysis is 0.25mg/Kg, with a maximum of 25mg,
Standard medical managementOther
Standard medical management
| Study group | Role | What they receive |
|---|---|---|
| Intravenous thrombolysis | Experimental | Patients in the TNK treatment group will receive TNK intravenous thrombolysis after MeVO is determined, and the usual dosage for TNK intravenous thrombolysis is 0.25mg/Kg, with a maximum of 25mg. Receives: Drug: Intravenous thrombolysis |
| Standard medical management | Active comparator | Standard medical management Receives: Other: Standard medical management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rates of 90 day good functional outcomes
(mRS score ≤ 1 is defined as good prognosis)
Measured: 90 (± 14 days) after procedure
Secondary outcomes (2)
2. Proportion of patients with functional independence outcome (mRS 0-2) at day 90
modified Rankin scale (range, 0 to 6, with a score of 0 indicating no disability, 1 no clinically significant disability, 2 slight disability, 3 moderate disability but remaining able to walk unassisted, 4 moderately severe disability, 5 severe disability, and 6 death)
Measured: 90 (± 14 days) after procedure
3. Proportion of patients with ambulatory and self-care capable outcome (mRS 0-3) at day 90
modified Rankin scale (range, 0 to 6, with a score of 0 indicating no disability, 1 no clinically significant disability, 2 slight disability, 3 moderate disability but remaining able to walk unassisted, 4 moderately severe disability, 5 severe disability, and 6 death)
Measured: 90 (± 14 days) after procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2024
- Study start2 Oct 2024
- Primary completion1 Sep 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
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 Acute Ischemic StrokeStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 560 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First Affiliated Hospital of University of Science and Technology of China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wei Hu, The First Affiliated Hospital of University of Science and Technology of China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06559436
- Sponsor's protocol ID
- TNK-MeVO
- Status last verified
- Oct 2024
- First submitted
- 14 Aug 2024
- Last updated
- 24 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Jing X, Nogueira RG, Nguyen T, Abdalkader M, Al-Qudah AM, Tao C, Li R, Sun J, Zhu Y, Wang L, Chao Z, Liu T, Song J, Saver JL, Hu W. Extending the time window for intravenous tenecteplase in patients with distal medium vessel occlusions stroke: study protocol and rationale. Stroke Vasc Neurol. 2026 Apr 13:svn-2025-004727. doi: 10.1136/svn-2025-004727. Online ahead of print.
PubMed 41974576
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Extending the Time Window for Intravenous Tenecteplase in Patients With Distal Medium Vessel Occlusions Stroke-a Randomised, Controlled, Multicentre Study
- ClinicalTrials.gov ID
- NCT06559436
- Acronym / sponsor ID
- TNK-MeVO
- Conditions
- Acute Ischemic Stroke
- Keywords
- Medium Vessel Occlusion, Stroke Due To Medium Vessel Occlusion, Beyond optimal time window, TNK intravenous thrombolysis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 560 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of University of Science and Technology of ChinaUniversity, hospital or other
- Study start
- 2 Oct 2024 (actual)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 19 Aug 2024 (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 assess the safety and efficacy of beyond time window TNK intravenous thrombolysis for distal Medium Vessel Occlusion (MeVO) related stroke in a prospective randomized clinical trial.
Detailed description
Previous study has confirmed that in acute ischemic stroke patients with large vessel occlusion within 4.5-24 hours of symptom onset and a salvageable penumbra on perfusion imaging, TNK thrombolysis is safe and can significantly improve the prognosis in the absence of mechanical thrombectomy. However, it is currently unknown whether TNK intravenous thrombolysis beyond optimal time window can improve the prognosis of distal Medium Vessel Occlusion (MeVO) related patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intravenous thrombolysis | Experimental | Drug: Intravenous thrombolysisPatients in the TNK treatment group will receive TNK intravenous thrombolysis after MeVO is determined, and the usual dosage for TNK intravenous thrombolysis is 0.25mg/Kg, with a maximum of 25mg. |
| Standard medical management | Active comparator | Other: Standard medical managementStandard medical management |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Evidence of a primary (e.g., not secondary to endovascular therapy of proximal vessel occlusion) distal medium vascular occlusion defined as occlusion of the co/non-dominant M2 segment*, M3, or M4 segment of the middle cerebral artery (MCA), the anterior cerebral artery (ACA) (A1, A2, A3, or A4 segments), or the posterior cerebral artery (PCA) (P1, P2, P3, or P4 segments);
- Age ≥18 years;
- Premorbid mRS 0-1;
- Evidence of a disabling stroke defined as follows:
- Less than 50% core in the territory supplied by the occluded vessel as evident by hypodensity and loss of grey-white border on NCCT or ADC <620 mm2/s on diffusion MRI or rCBF<30% on CTP after 6h of symptom onset.
Key exclusion criteria (19 listed)
- Received intravenous thrombolysis prior to randomization;
- Allergy to Tenecteplase;
- Seizures, or other neurological/mental illness at stroke onset if it precludes obtaining an accurate baseline NIHSS;
- Patients planned to undergo MT or other endovascular treatments (e.g., intra-arterial thrombolysis);
- Systolic blood pressure>185 mmHg or diastolic blood pressure>110 mmHg, which cannot be controlled by antihypertensive drug(s);
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 |
|---|---|---|
| Intravenous thrombolysisPatients in the TNK treatment group will receive TNK intravenous thrombolysis after MeVO is determined, and the usual dosage for TNK intravenous thrombolysis is 0.25mg/Kg, with a maximum of 25mg, | Drug | Intravenous thrombolysis |
| Standard medical managementStandard medical management | Other | Standard medical management |
Primary outcome
Rates of 90 day good functional outcomes
Time frame: 90 (± 14 days) after procedure
(mRS score ≤ 1 is defined as good prognosis)
2 secondary outcomes
2. Proportion of patients with functional independence outcome (mRS 0-2) at day 90
Time frame: 90 (± 14 days) after procedure
3. Proportion of patients with ambulatory and self-care capable outcome (mRS 0-3) at day 90
Time frame: 90 (± 14 days) after procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2024.
- Derived from this study: PubMed 41974576Jing X, Nogueira RG, Nguyen T, Abdalkader M, Al-Qudah AM, Tao C, Li R, Sun J, Zhu Y, Wang L, Chao Z, Liu T, Song J, Saver JL, Hu W. Extending the time window for intravenous tenecteplase in patients with distal medium vessel occlusions stroke: study protocol and rationale. Stroke Vasc Neurol. 2026 Apr 13:svn-2025-004727. doi: 10.1136/svn-2025-004727. Online ahead of print.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intravenous thrombolysis and Standard medical management in people with Acute Ischemic Stroke, run by The First Affiliated Hospital of University of Science and Technology of China 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 10 inclusion and 19 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: looking for participants now, as of the sponsor's last update on 24 Oct 2024. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wei Hu, MD, PhD (+86 055162284313, andinghu@ustc.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rates of 90 day good functional outcomes (time frame: 90 (± 14 days) after procedure). 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 NCT06559436, 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 24 Oct 2024.