Minor Ischemic StrokePhase 3TRACE ⅣNCT06414499
Teneteplase Reperfusion Therapy in Acute Ischemic Cerebrovascular Events-Ⅳ
A Phase 3 study testing rhTNK-tPA in people with Minor Ischemic Stroke, run by Beijing Tiantan Hospital at 1 site in China.
Trial summary
The purpose of this study is to evaluate the efficacy and safety of intravenous tenecteplase (0.25 mg/kg) compared with standard therapy in patients with acute ischemic stroke presenting with mild symptoms-defined as a National Institutes of Health Stroke Scale (NIHSS) score ≤5 accompanied by persistent unilateral… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Minor Ischemic Stroke
- What is being tested?
- rhTNK-tPA
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,386 participants
- Where
- 1 siteChina
- Study dates
- 9 Jul 2025to 31 Oct 2026
- 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
- Age ≥ 18 years;
- Onset-to-treatment time < 4.5 h; onset time defined as "last known well" time;
- Clinical diagnosis of minor ischemic stroke (NIHSS ≤ 5) with persistent unilateral limb weakness or speech symptoms, defined as a score of ≥1 on either the language item or a single limb item of the NIHSS;
- Pre-stroke mRS 0-1;
- Informed consent signed.
Who cannot join
- Planned or likely acute endovascular treatments before randomization;
- NIHSS 1a > 2;
- Known allergic to rhTNK-tPA;
- History of intracranial hemorrhage;
- Severe head trauma or previous stroke within 3 months；
- Intracranial or spinal surgery within 3 months;
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- Gastrointestinal or urinary tract hemorrhage within 3 weeks；
- Major surgery within 2 weeks;
- Arterial puncture at a non-compressible site within 1 week；
- Intracranial tumors (excluding neuroectodermal tumors, e.g., meningiomas), large intracranial aneurysms, or arteriovenous malformations；
- Intracranial hemorrhage, including intraparenchymal hemorrhage, intraventricular hemorrhage, subarachnoid hemorrhage, and subdural/epidural hematoma;
- Active visceral bleeding;
- Concomitantaortic arch dissection;
- Acute bleeding tendency, including platelet count <100×10⁹/L or other clinically significant conditions;
- Uncontrolled hypertension after active antihypertensive treatment: systolic blood pressure >180 mm Hg or diastolic >100 mm Hg;
- Blood glucose < 2.8 or > 22.2 mmol / L;
- Prior anticoagulant therapy, such as oral warfarin, with an INR >1.7 or PT >15 seconds;
- Use of heparin within 24 hours;
- Use of thrombin inhibitors or factor Xa inhibitors within 48 hours;
- Large cerebral infarction on head CT or MRI (infarction area >1/3 of the middle cerebral artery territory);
- Todd's paralysis after a seizure or other neurological/psychiatric disorders affecting cooperation;
- Severe, uncontrolled infections (e.g., acute pericarditis, infective endocarditis, or acute pancreatitis);
- Pregnant or breastfeeding women, or women unwilling to use effective contraception during the study period;
- Participation in another clinical trial within 3 months prior to screening;
- Other severe illnesses with a life expectancy of less than six months;
- Deemed unsuitable for the study or at increased risk by the investigator's judgment.
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
Beijing Tiantan Hospital
Beijing, Beijing Municipality
Yongjun Wang, Dr., yongjunwang111@aliyun.com
About this study
Official title: TNK-tPA Treatment for Acute Minor Ischemic Stroke：A Randomized, Double-blind, Double-dummy Controlled Trial
The purpose of this study is to evaluate the efficacy and safety of intravenous tenecteplase (0.25 mg/kg) compared with standard therapy in patients with acute ischemic stroke presenting with mild symptoms-defined as a National Institutes of Health Stroke Scale (NIHSS) score ≤5 accompanied by persistent unilateral limb weakness or speech impairment within 4.5 hours of onset.
Read the detailed description
This study is a multicenter, prospective, randomized, double-blind, double-dummy controlled (2 arms with 1:1 randomization) trial. Participants with acute minor ischemic stroke (baseline NIHSS≤5) within 4.5 hours of symptoms onset (symptom onset is defined by the "last seen normal" principle for wake-up stroke) will be enrolled. Eligible patients must have neurological deficits involving at least language or motor function. Participants will be randomized into 2 groups: Intervention group (rhTNK-tPA): 0.25mg/kg, the maximum dose does not exceed 25mg, plus placebo oral aspirin and clopidogrel. Aspirin 100mg and clopidogrel 300mg will be given within 6 ± 2 hours after thrombolytic therapy. Control group: Dual antiplatelet therapy with aspirin 100mg and clopidogrel 300mg, plus placebo intravenous rhTNK-tPA. Placebo oral aspirin and clopidogrel will be given within 6 ± 2 hours following the placebo thrombolytic therapy.The primary endpoint is an excellent functional outcome (a modified Rankin Scale score of 0-1) at 90-day.
- Conditions
- Minor Ischemic Stroke
- Being tested
- rhTNK-tPA, Control group (Aspirin combined with clopidogrel)
- Keywords
- minor stroke, tenecteplase
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rhTNK-tPADrug
rhTNK-tPA 0.25mg/kg, the maximum dose does not exceed 25mg: 1 vial is dissolved in 3ml of sterile water for injection to prepare a medicinal solution with a concentration of 5.33mg/ml. Calculate the total amount of the drug according to the weight of participant, and the maximum dose shall not exceed 25 mg. It is administered as a single bolus intravenous injection, and the injection is completed within 5-10 seconds. Additionally, placebo oral aspirin and clopidogrel are given. Aspirin 100 mg and clopidogrel 300 mg are administered within 6 ± 2 hours following thrombolytic therapy.
Control group (Aspirin combined with clopidogrel)Drug
Dual antiplatelets with aspirin 100mg and clopidogrel 300mg, plus placebo intravenous rhTNK-tPA. Placebo oral aspirin and clopidogrel are administered within 6 ± 2 hours following intravenous placebo.
| Study group | Role | What they receive |
|---|---|---|
| Aspirin combined with clopidogrel | Placebo comparator | Aspirin 100mg combined with clopidogrel 300mg, plus placebo intravenous rhTNK-tPA Receives: Drug: Control group (Aspirin combined with clopidogrel) |
| rhTNK-tPA (0.25 mg/kg) | Experimental | rhTNK-tPA (0.25 mg/kg, max 25 mg) with placebo oral aspirin and clopidogrel Receives: Drug: rhTNK-tPA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Excellent functional outcome (Modified Rankin Scale score, mRS 0-1) at 90-day (± 7 days).
Modified Rankin Scale score, mRS 0-1
Measured: at 90-day (± 7 days)
Secondary outcomes (16)
Good functional outcome (mRS 0-2) at 90-day (± 7 days)
Measured: at 90-day (± 7 days)
mRS score at 90-day (± 7 days)
shift analysis/ordinal distribution of mRS score at 90-day (±7 days)
Measured: at 90-day (± 7 days)
COSMOS Scale 0-1 at 90-day (±7days)
Measured: 90-day± 7days
COSMOS scale at 90-day (±7 days)
shift analysis/ordinal distribution of COSMOS scale at 90-day (±7 days)
Measured: 90-day± 7days
NIHSS 0-1 at 24-hour, 7-day or before discharge (analyze which occurs first) or/ neurological improvement (NIHSS decreased≥4 from baseline)
Measured: at 24-hour, 7-day or before discharge (analyze which occurs first)
Neurological deterioration at 90 days
defined as an increase of ≥4 points in NIHSS score compared to baseline.
Measured: 90-day (±7 days)
New clinical vascular events (ischemic stroke/ hemorrhagic stroke/ myocardial infarction/vascular death) at 90-day (± 7 days), with each vascular event being independently evaluated.
Measured: at 90-day (± 7 days)
European quality of life visual analogue scale at 90 days
Measured: at 90-day (± 7 days)
Symptomatic intracranial hemorrhage according to the ECASSIII criteria within 36-hour.
Measured: within 36-hour
Symptomatic intracranial hemorrhage according to the ECASSIII criteria within 7 days or before discharge.
Measured: within 7 days or before discharge
Symptomatic intracranial hemorrhage according to the ECASSIII criteria within 90-day (± 7 days)
Measured: within 90-day (± 7 days)
PH2 type intracranial hemorrhage according to the Heidelberg criteria within 90-day (± 7 days)
Measured: within 90-day (± 7 days)
Any intracranial hemorrhage within 90-day (± 7 days)
Measured: within 90-day (± 7 days)
Severe bleeding events according to the GUSTO criteria within 90-day (± 7 days)
Measured: within 90-day (± 7 days)
Total mortality within 90-day (± 7 days)
Measured: within 90-day (± 7 days)
Adverse events/Severe adverse events within 90-day (± 7 days)
Measured: within 90-day (± 7 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2024
- Study start9 Jul 2025
- Primary completion31 Jul 2026 (estimated)
- Study completion31 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Minor Ischemic StrokeStudies of the same condition, open and under way.
- More trials run by Beijing Tiantan HospitalThe 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,386 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Tiantan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yongjun Wang, Beijing Tiantan Hospital
- Investigators
- Yongjun Wang, MD, PhD, Study director, Beijing Tiantan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06414499
- Sponsor's protocol ID
- NCRC-2024-03
- Acronym
- TRACE Ⅳ
- Status last verified
- Jul 2025
- First submitted
- 10 May 2024
- Last updated
- 24 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TNK-tPA Treatment for Acute Minor Ischemic Stroke：A Randomized, Double-blind, Double-dummy Controlled Trial
- ClinicalTrials.gov ID
- NCT06414499
- Acronym / sponsor ID
- TRACE Ⅳ / NCRC-2024-03
- Conditions
- Minor Ischemic Stroke
- Keywords
- minor stroke, tenecteplase
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,386 participants (estimated)
- Lead sponsor
- Beijing Tiantan HospitalUniversity, hospital or other
- Study start
- 9 Jul 2025 (actual)
- Primary completion
- 31 Jul 2026 (estimated)
- Study completion
- 31 Oct 2026 (estimated)
- First posted
- 16 May 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.
The purpose of this study is to evaluate the efficacy and safety of intravenous tenecteplase (0.25 mg/kg) compared with standard therapy in patients with acute ischemic stroke presenting with mild symptoms-defined as a National Institutes of Health Stroke Scale (NIHSS) score ≤5 accompanied by persistent unilateral limb weakness or speech impairment within 4.5 hours of onset.
Detailed description
This study is a multicenter, prospective, randomized, double-blind, double-dummy controlled (2 arms with 1:1 randomization) trial. Participants with acute minor ischemic stroke (baseline NIHSS≤5) within 4.5 hours of symptoms onset (symptom onset is defined by the "last seen normal" principle for wake-up stroke) will be enrolled. Eligible patients must have neurological deficits involving at least language or motor function. Participants will be randomized into 2 groups: Intervention group (rhTNK-tPA): 0.25mg/kg, the maximum dose does not exceed 25mg, plus placebo oral aspirin and clopidogrel. Aspirin 100mg and clopidogrel 300mg will be given within 6 ± 2 hours after thrombolytic therapy. Control group: Dual antiplatelet therapy with aspirin 100mg and clopidogrel 300mg, plus placebo intravenous rhTNK-tPA. Placebo oral aspirin and clopidogrel will be given within 6 ± 2 hours following the placebo thrombolytic therapy.The primary endpoint is an excellent functional outcome (a modified Rankin Scale score of 0-1) at 90-day.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aspirin combined with clopidogrel | Placebo comparator | Drug: Control group (Aspirin combined with clopidogrel)Aspirin 100mg combined with clopidogrel 300mg, plus placebo intravenous rhTNK-tPA |
| rhTNK-tPA (0.25 mg/kg) | Experimental | Drug: rhTNK-tPArhTNK-tPA (0.25 mg/kg, max 25 mg) with placebo oral aspirin and clopidogrel |
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;
- Onset-to-treatment time < 4.5 h; onset time defined as "last known well" time;
- Clinical diagnosis of minor ischemic stroke (NIHSS ≤ 5) with persistent unilateral limb weakness or speech symptoms, defined as a score of ≥1 on either the language item or a single limb item of the NIHSS;
- Pre-stroke mRS 0-1;
- Informed consent signed.
Key exclusion criteria (26 listed)
- Planned or likely acute endovascular treatments before randomization;
- NIHSS 1a > 2;
- Known allergic to rhTNK-tPA;
- History of intracranial hemorrhage;
- Severe head trauma or previous stroke within 3 months；
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 |
|---|---|---|
| rhTNK-tPArhTNK-tPA 0.25mg/kg, the maximum dose does not exceed 25mg: 1 vial is dissolved in 3ml of sterile water for injection to prepare a medicinal solution with a concentration of 5.33mg/ml. Calculate the total amount of the drug according to the weight of participant, and the maximum dose shall not exceed 25 mg. It is administered as a single bolus intravenous injection, and the injection is completed within 5-10 seconds. Additionally, placebo oral aspirin and clopidogrel are given. Aspirin 100 mg and clopidogrel 300 mg are administered within 6 ± 2 hours following thrombolytic therapy. | Drug | rhTNK-tPA (0.25 mg/kg) |
| Control group (Aspirin combined with clopidogrel)Dual antiplatelets with aspirin 100mg and clopidogrel 300mg, plus placebo intravenous rhTNK-tPA. Placebo oral aspirin and clopidogrel are administered within 6 ± 2 hours following intravenous placebo. | Drug | Aspirin combined with clopidogrel |
Primary outcome
Excellent functional outcome (Modified Rankin Scale score, mRS 0-1) at 90-day (± 7 days).
Time frame: at 90-day (± 7 days)
Modified Rankin Scale score, mRS 0-1
16 secondary outcomes
Good functional outcome (mRS 0-2) at 90-day (± 7 days)
Time frame: at 90-day (± 7 days)
mRS score at 90-day (± 7 days)
Time frame: at 90-day (± 7 days)
COSMOS Scale 0-1 at 90-day (±7days)
Time frame: 90-day± 7days
COSMOS scale at 90-day (±7 days)
Time frame: 90-day± 7days
NIHSS 0-1 at 24-hour, 7-day or before discharge (analyze which occurs first) or/ neurological improvement (NIHSS decreased≥4 from baseline)
Time frame: at 24-hour, 7-day or before discharge (analyze which occurs first)
Neurological deterioration at 90 days
Time frame: 90-day (±7 days)
New clinical vascular events (ischemic stroke/ hemorrhagic stroke/ myocardial infarction/vascular death) at 90-day (± 7 days), with each vascular event being independently evaluated.
Time frame: at 90-day (± 7 days)
European quality of life visual analogue scale at 90 days
Time frame: at 90-day (± 7 days)
Symptomatic intracranial hemorrhage according to the ECASSIII criteria within 36-hour.
Time frame: within 36-hour
Symptomatic intracranial hemorrhage according to the ECASSIII criteria within 7 days or before discharge.
Time frame: within 7 days or before discharge
Symptomatic intracranial hemorrhage according to the ECASSIII criteria within 90-day (± 7 days)
Time frame: within 90-day (± 7 days)
PH2 type intracranial hemorrhage according to the Heidelberg criteria within 90-day (± 7 days)
Time frame: within 90-day (± 7 days)
Any intracranial hemorrhage within 90-day (± 7 days)
Time frame: within 90-day (± 7 days)
Severe bleeding events according to the GUSTO criteria within 90-day (± 7 days)
Time frame: within 90-day (± 7 days)
Total mortality within 90-day (± 7 days)
Time frame: within 90-day (± 7 days)
Adverse events/Severe adverse events within 90-day (± 7 days)
Time frame: within 90-day (± 7 days)
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 Jul 2025.
- 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.
Yongjun Wang, MD, PhD study director
Beijing Tiantan Hospital
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 rhTNK-tPA in people with Minor Ischemic Stroke, run by Beijing Tiantan Hospital 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 26 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 Jul 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. 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 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 Yongjun Wang, MD, PhD (86-13911172565, yongjunwang@ncrcnd.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Excellent functional outcome (Modified Rankin Scale score, mRS 0-1) at 90-day (± 7 days). (time frame: at 90-day (± 7 days)). 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 24 Jul 2025.