StrokePhase 3TIME-MINORNCT07476898
Precision Reperfusion Therapy for Disabling Minor Stroke With Large Vessel Occlusion Beyond Time Window
A Phase 3 study testing Tenecteplase (0.25mg/kg) and Standard Medical Management in people with Stroke, run by First Hospital of China Medical University at 30 sites in China.
Trial summary
To verify the efficacy and safety of intravenous tenecteplase (TNK) in patients with disabling minor stroke and large vessel occlusion (LVO) within a 4.5-24 hour time window. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- Tenecteplase (0.25mg/kg) and Standard Medical Management
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 864 participants
- Where
- 30 sitesChina
- Study dates
- 1 Mar 2026to 1 Aug 2028
- Phase
- Phase 3
- 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
- Male or female subjects (age ≥ 18 years).
- Diagnosis of acute ischemic stroke, with intracranial hemorrhage ruled out by CT or MRI.
- Time from stroke onset or last known well to randomization is 4.5 to 24 hours.
- NIHSS score 2-5 and meeting the definition of disabling deficit: complete hemianopia (NIHSS question 3 score ≥ 2); severe aphasia (NIHSS question 9 score ≥ 2); neglect (NIHSS question 11 score ≥ 1); any persistent limb weakness against gravity (NIHSS question 6 or 7 score ≥ 2); any functional deficit considered potentially disabling by the physician and patient, such as inability to perform basic activities of daily living (bathing, independent walking, toileting, personal hygiene, and eating) or return to work.
- LVO (internal carotid artery, middle cerebral artery M1/M2 segments) confirmed by CTA or MRA, including tandem lesions.
- Core infarct volume < 70 ml, ischemic penumbra volume ≥ 15 ml, and mismatch ratio ≥ 1.8, as shown by CTP or MRI+MRP.
- Written informed consent.
Who cannot join
- Significant pre-stroke neurological deficit (pre-stroke mRS ≥ 2).
- History of stroke within the last 3 months.
- History of intracranial hemorrhage.
- Suspected subarachnoid hemorrhage.
- Intracranial tumor, vascular malformation, or aneurysm.
- Major surgery within the last 1 month.
Show all 16Show fewer
- Systolic blood pressure ≥ 180 mmHg or diastolic blood pressure ≥ 110 mmHg.
- Platelet count < 10⁵/mm³.
- Heparin or oral anticoagulant therapy within 48 hours.
- Abnormal APTT.
- Thrombin or factor Xa inhibitors.
- Severe illness with life expectancy < 3 months.
- Blood glucose < 50 mg/dL (2.7 mmol/L).
- Participation in any other investigational drug or device study within the last 3 months.
- Pregnancy.
- Patients deemed unsuitable for the registry study by the investigator.
Trial locations and contacts
30 sites in 1 country. Contact the study team or a site near you to ask about taking part.
30 sites in 1 country
China30 sites
Anshan Central Hospital
Anshan, Liaoning, 114001
Hongbo Xiao, +86 13942211121
Anshan Changda Hospital
Anshan, Liaoning, 114005
Yulin Song, +86 18941269240
Benxi Central Hospital
Benxi, Liaoning, 117000
Chengguang Song, +86 15141488936
Chaoyang Central Hospital
Chaoyang, Liaoning, 122000
Xiaomei He, +86 18040158900
Dalian Municipal Central Hospital Affiliated of Dalian University of Technology
Dalian, Liaoning, 116033
Di Li, +86 15040593175, lijinw07@126.com
Dandong Central Hospital
Dandong, Liaoning, 118000
Ming Sun, +86 13842590407
Dandong First Hospital
Dandong, Liaoning, 118000
Lishu Wan, +86 18004955099
Fushun Central Hospital
Fushun, Liaoning, 113006
Yan Yang, +86 13941358008
Liaojian Group Fukuang General Hospital
Fushun, Liaoning, 113008
Hong Zhang, +86 13941363522
Fuxin People's Hospital
Fuxin, Liaoning, 123000
Ying Bao, +86 13384189988
Fujian Medical University Union Hospital
Fuzhou, Fujian, 350001
Wenhuo Chen, M.D, +86 13806906089, lijinw07@126.com
Huludao Central Hospital
Huludao, Liaoning, 125000
Changming Xu, +86 15382008866
The First Affiliated Hospital of Jinzhou Medical University
Jinzhou, Liaoning, 121001
Li Liu, +86 13591642556
Liaoyang Central Hospital
Liaoyang, Liaoning, 111000
Xinbin Hao, +86 13841998567
Panjin Central Hospital
Panjin, Liaoning, 124010
Zhuo Li, +86 18942750777
The Second Affiliated Hospital of Shenyang Medical College
Shenyang, Liaoning, 110002
Yan Du, +86 18002453421
Liaoning Provincial People's Hospital
Shenyang, Liaoning, 110016
Muhui Lin, +86 17702485111
Shenyang Fifth People's Hospital
Shenyang, Liaoning, 110023
Jinchun Wang, +86 13889228138
Central Hospital Affiliated to Shenyang Medical College
Shenyang, Liaoning, 110024
Runhui Li, +86 18002477116
Shenyang Fourth People's Hospital
Shenyang, Liaoning, 110031
The Fourth Affiliated Hospital of China Medical University
Shenyang, Liaoning, 110032
Zhenwei He, +86 18900913396
Shenyang First People's Hospital
Shenyang, Liaoning, 110041
Li Li, +86 13840247222
Shenyang Tenth People's Hospital
Shenyang, Liaoning, 110044
Sujiatun District Central Hospital
Shenyang, Liaoning, 110101
Hongxia Zhao, +86 13842001757
Tieling Central Hospital
Tieling, Liaoning, 112000
Yong Liang, +86 13941047667
Tieling County Central Hospital
Tieling, Liaoning, 112600
Liying Shen, +86 13804107177
Liaojian Group Tieling Coal General Hospital
Tieling, Liaoning, 112700
Gaohua Li, +86 15694138278
Wafangdian Central Hospital
Wafangdian, Liaoning, 116300
Wei Li, +86 15566896782
Wafangdian Third People's Hospital
Wafangdian, Liaoning, 116300
Renlin Zou, +86 15641120499
Yingkou Central Hospital
Yingkou, Liaoning, 115000
Dongqun Li, +86 13941728080
About this study
Official title: A Multicenter, Randomized, Open-Label, Blinded-Endpoint Trial of Tenecteplase Versus Dual Antiplatelet Therapy in Mild Disabling Ischemic Stroke With Large Vessel Occlusion Beyond 4.5 Hours (TIME-MINOR Trial)
To verify the efficacy and safety of intravenous tenecteplase (TNK) in patients with disabling minor stroke and large vessel occlusion (LVO) within a 4.5-24 hour time window.
Read the detailed description
Stroke is a leading cause of death and disability. Minor stroke (NIHSS ≤5) accounts for 48% of ischemic strokes, with its "mild symptom" presentation masking the potential risk of disability. About 30% of patients have poor 90-day outcomes (mRS ≥2) due to disabling deficits (e.g., unilateral limb weakness ≥2, aphasia, or hemianopia), resulting not only in loss of personal independence but also a surge in family and social medical expenses. Notably, up to 55% of patients present beyond the standard time window (4.5-24 hours). Having missed the golden window for thrombolysis, they are often relegated to conservative treatment. When complicated by large vessel occlusion (LVO), the recanalization rate with dual antiplatelet therapy (DAPT) alone is less than 5%, creating a "silent epidemic" of accumulating disability risk.
The PRISMS trial showed no benefit of thrombolysis within 4.5 hours in non-disabling stroke, but due to the exclusion of the LVO subgroup and early termination (actual enrollment only 313), the potential benefit for disabling patients remains an open question. The TEMPO-2 trial found increased mortality (5% vs 1%) in patients receiving tenecteplase (TNK) without selecting for ischemic penumbra, potentially masking recanalization benefits in certain subgroups (e.g., those with mismatch ratio ≥1.8). A subgroup analysis of TEMPO-2 for onset 4.5-12h, minor disabling stroke (median NIHSS 4), showed a 3-month mRS 0-1 rate of 61.7% in the tenecteplase group vs. 47.2% in the standard care group, but this was not statistically significant due to the small subgroup size. While CHANCE series studies confirmed that DAPT reduces the risk of stroke recurrence by 33%, it is ineffective for LVO recanalization, leaving disability rates high.
The 2023 "Chinese Guidelines for Clinical Management of Cerebrovascular Diseases" and the European Stroke Organisation (ESO) guidelines explicitly state that treatment for disabling minor stroke with LVO beyond the time window (4.5-24 hours) lacks a Class I recommendation (Evidence Level C), leaving clinical decision-making in a dilemma without evidence-based guidance.
DAWN/DEFUSE-3/TRACE Ⅲ studies validated the value of imaging selection in thrombectomy, but they excluded patients with NIHSS ≤5, leaving a gap in penumbra assessment criteria for minor stroke.
Therefore, the investigators designed the TIME-MINOR trial to evaluate whether intravenous tenecteplase, guided by multimodal imaging, can improve outcomes in patients with NIHSS ≤5 and LVO presenting 4.5-24 hours after onset.
- Conditions
- Stroke
- Being tested
- Tenecteplase (0.25mg/kg), Standard Medical Management
- Keywords
- Ischemic Stroke with Large Vessel Occlusion, Tenecteplase, beyond 4.5 hours
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tenecteplase (0.25mg/kg)Drug
Tenecteplase (0.25 mg/kg, intravenous bolus, maximum dose 25 mg) + Delayed dual antiplatelet therapy (initiated 24 hours after thrombolysis: Aspirin 100 mg orally once daily + Clopidogrel 75 mg orally once daily, or Aspirin 100 mg + Ticagrelor 90 mg orally twice daily, continued for 21 days)
Standard Medical ManagementDrug
Immediate dual antiplatelet therapy (Aspirin 100 mg orally once daily + Clopidogrel 75 mg orally once daily, or Aspirin 100 mg + Ticagrelor 90 mg orally twice daily, continued for 21 days)
| Study group | Role | What they receive |
|---|---|---|
| Tenecteplase | Experimental | Tenecteplase (0.25 mg/kg, intravenous bolus, maximum dose 25 mg) + Standard Medical Management Receives: Drug: Tenecteplase (0.25mg/kg) |
| Standard Medical Management | Active comparator | Immediate Standard Medical Management Receives: Drug: Standard Medical Management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with a modified Rankin Scale (mRS) score of 0-1 at 90 days.
Proportion of patients with a modified Rankin Scale (mRS) score of 0-1 at 90 days.
Measured: 3 months after randomization
Secondary outcomes (7)
Proportion of patients with mRS 0-2 at 90 days.
Proportion of patients with mRS 0-2 at 90 days.
Measured: 3 months after randomization
Distribution of mRS score at 90 days.
Distribution of mRS score at 90 days.
Measured: 3 months after randomization
Rate of vessel recanalization.
Rate of vessel recanalization.
Measured: 3 months after randomization
Proportion of patients undergoing rescue mechanical thrombectomy.
Proportion of patients undergoing rescue mechanical thrombectomy.
Measured: cerebral infarction within 24 hours of onset
Proportion of patients with NIHSS score 0-1 or an improvement of ≥4 points from baseline at 24 hours, 7 days, or discharge (whichever occurs first).
Proportion of patients with NIHSS score 0-1 or an improvement of ≥4 points from baseline at 24 hours, 7 days, or discharge (whichever occurs first).
Measured: 24 hours, 7 days, or discharge after randomization
Proportion of patients with neurological deterioration at 90 days (increase in NIHSS score ≥4 points from baseline at the 90-day follow-up).
Proportion of patients with neurological deterioration at 90 days (increase in NIHSS score ≥4 points from baseline at the 90-day follow-up).
Measured: 3 months after randomization
New vascular events within 90 days (including ischemic stroke, hemorrhagic stroke, myocardial infarction, and vascular death), with independent evaluation of each event.
New vascular events within 90 days (including ischemic stroke, hemorrhagic stroke, myocardial infarction, and vascular death), with independent evaluation of each event.
Measured: 3 months after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2026
- Study start1 Mar 2026 (estimated)
- Primary completion1 Jul 2028 (estimated)
- Study completion1 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Multicenter, randomized, open-label, blinded-endpoint (PROBE design), 1:1 allocation, 90-day follow-up.
- Masking
- None (open label)
- Enrolment
- 864 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First Hospital of China Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chuansheng Zhao, First Hospital of China Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07476898
- Sponsor's protocol ID
- TIME-MINOR-2026
- Acronym
- TIME-MINOR
- Status last verified
- Mar 2026
- First submitted
- 10 Mar 2026
- Last updated
- 17 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Open-Label, Blinded-Endpoint Trial of Tenecteplase Versus Dual Antiplatelet Therapy in Mild Disabling Ischemic Stroke With Large Vessel Occlusion Beyond 4.5 Hours (TIME-MINOR Trial)
- ClinicalTrials.gov ID
- NCT07476898
- Acronym / sponsor ID
- TIME-MINOR / TIME-MINOR-2026
- Conditions
- Stroke
- Keywords
- Ischemic Stroke with Large Vessel Occlusion, Tenecteplase, beyond 4.5 hours
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 864 participants (estimated)
- Lead sponsor
- First Hospital of China Medical UniversityUniversity, hospital or other
- Study start
- 1 Mar 2026 (estimated)
- Primary completion
- 1 Jul 2028 (estimated)
- Study completion
- 1 Aug 2028 (estimated)
- First posted
- 17 Mar 2026 (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 verify the efficacy and safety of intravenous tenecteplase (TNK) in patients with disabling minor stroke and large vessel occlusion (LVO) within a 4.5-24 hour time window.
Detailed description
Stroke is a leading cause of death and disability. Minor stroke (NIHSS ≤5) accounts for 48% of ischemic strokes, with its "mild symptom" presentation masking the potential risk of disability. About 30% of patients have poor 90-day outcomes (mRS ≥2) due to disabling deficits (e.g., unilateral limb weakness ≥2, aphasia, or hemianopia), resulting not only in loss of personal independence but also a surge in family and social medical expenses. Notably, up to 55% of patients present beyond the standard time window (4.5-24 hours). Having missed the golden window for thrombolysis, they are often relegated to conservative treatment. When complicated by large vessel occlusion (LVO), the recanalization rate with dual antiplatelet therapy (DAPT) alone is less than 5%, creating a "silent epidemic" of accumulating disability risk.
The PRISMS trial showed no benefit of thrombolysis within 4.5 hours in non-disabling stroke, but due to the exclusion of the LVO subgroup and early termination (actual enrollment only 313), the potential benefit for disabling patients remains an open question. The TEMPO-2 trial found increased mortality (5% vs 1%) in patients receiving tenecteplase (TNK) without selecting for ischemic penumbra, potentially masking recanalization benefits in certain subgroups (e.g., those with mismatch ratio ≥1.8). A subgroup analysis of TEMPO-2 for onset 4.5-12h, minor disabling stroke (median NIHSS 4), showed a 3-month mRS 0-1 rate of 61.7% in the tenecteplase group vs. 47.2% in the standard care group, but this was not statistically significant due to the small subgroup size. While CHANCE series studies confirmed that DAPT reduces the risk of stroke recurrence by 33%, it is ineffective for LVO recanalization, leaving disability rates high.
The 2023 "Chinese Guidelines for Clinical Management of Cerebrovascular Diseases" and the European Stroke Organisation (ESO) guidelines explicitly state that treatment for disabling minor stroke with LVO beyond the time window (4.5-24 hours) lacks a Class I recommendation (Evidence Level C), leaving clinical decision-making in a dilemma without evidence-based guidance.
DAWN/DEFUSE-3/TRACE Ⅲ studies validated the value of imaging selection in thrombectomy, but they excluded patients with NIHSS ≤5, leaving a gap in penumbra assessment criteria for minor stroke.
Therefore, the investigators designed the TIME-MINOR trial to evaluate whether intravenous tenecteplase, guided by multimodal imaging, can improve outcomes in patients with NIHSS ≤5 and LVO presenting 4.5-24 hours after onset.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Multicenter, randomized, open-label, blinded-endpoint (PROBE design), 1:1 allocation, 90-day follow-up.
| Arm | Type | Receives |
|---|---|---|
| Tenecteplase | Experimental | Drug: Tenecteplase (0.25mg/kg)Tenecteplase (0.25 mg/kg, intravenous bolus, maximum dose 25 mg) + Standard Medical Management |
| Standard Medical Management | Active comparator | Drug: Standard Medical ManagementImmediate Standard Medical Management |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male or female subjects (age ≥ 18 years).
- Diagnosis of acute ischemic stroke, with intracranial hemorrhage ruled out by CT or MRI.
- Time from stroke onset or last known well to randomization is 4.5 to 24 hours.
- NIHSS score 2-5 and meeting the definition of disabling deficit: complete hemianopia (NIHSS question 3 score ≥ 2); severe aphasia (NIHSS question 9 score ≥ 2); neglect (NIHSS question 11 score ≥ 1); any persistent limb weakness against gravity (NIHSS question 6 or 7 score ≥ 2); any functional deficit considered potentially disabling by the physician and patient, such as inability to perform basic activities of daily living (bathing, independent walking, toileting, personal hygiene, and eating) or return to work.
- LVO (internal carotid artery, middle cerebral artery M1/M2 segments) confirmed by CTA or MRA, including tandem lesions.
Key exclusion criteria (16 listed)
- Significant pre-stroke neurological deficit (pre-stroke mRS ≥ 2).
- History of stroke within the last 3 months.
- History of intracranial hemorrhage.
- Suspected subarachnoid hemorrhage.
- Intracranial tumor, vascular malformation, or aneurysm.
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 |
|---|---|---|
| Tenecteplase (0.25mg/kg)Tenecteplase (0.25 mg/kg, intravenous bolus, maximum dose 25 mg) + Delayed dual antiplatelet therapy (initiated 24 hours after thrombolysis: Aspirin 100 mg orally once daily + Clopidogrel 75 mg orally once daily, or Aspirin 100 mg + Ticagrelor 90 mg orally twice daily, continued for 21 days) | Drug | Tenecteplase |
| Standard Medical ManagementImmediate dual antiplatelet therapy (Aspirin 100 mg orally once daily + Clopidogrel 75 mg orally once daily, or Aspirin 100 mg + Ticagrelor 90 mg orally twice daily, continued for 21 days) | Drug | Standard Medical Management |
Primary outcome
Proportion of patients with a modified Rankin Scale (mRS) score of 0-1 at 90 days.
Time frame: 3 months after randomization
Proportion of patients with a modified Rankin Scale (mRS) score of 0-1 at 90 days.
7 secondary outcomes
Proportion of patients with mRS 0-2 at 90 days.
Time frame: 3 months after randomization
Distribution of mRS score at 90 days.
Time frame: 3 months after randomization
Rate of vessel recanalization.
Time frame: 3 months after randomization
Proportion of patients undergoing rescue mechanical thrombectomy.
Time frame: cerebral infarction within 24 hours of onset
Proportion of patients with NIHSS score 0-1 or an improvement of ≥4 points from baseline at 24 hours, 7 days, or discharge (whichever occurs first).
Time frame: 24 hours, 7 days, or discharge after randomization
Proportion of patients with neurological deterioration at 90 days (increase in NIHSS score ≥4 points from baseline at the 90-day follow-up).
Time frame: 3 months after randomization
New vascular events within 90 days (including ischemic stroke, hemorrhagic stroke, myocardial infarction, and vascular death), with independent evaluation of each event.
Time frame: 3 months after randomization
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 17 Mar 2026.
- Individual participant dataSharing planned: Yes
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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.
30 sites 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 (0.25mg/kg) and Standard Medical Management in people with Stroke, run by First Hospital of China Medical University at 30 sites 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 7 inclusion and 16 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: opening soon, as of the sponsor's last update on 17 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 30 sites 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?
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 Chuansheng Zhao, M.D (+86 13940369251, cszhao@mail.cmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients with a modified Rankin Scale (mRS) score of 0-1 at 90 days. (time frame: 3 months after randomization). 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 17 Mar 2026; AzTrials last refreshed its copy on 30 Oct 2026.