StrokePhase 3TRACE-BEYONDNCT06954155
Tenecteplase Reperfusion Therapy in Acute Ischemic Cerebrovascular Events-BEYOND
A Phase 3 study testing Tenecteplase (0.25mg/kg) and Standard medical treatment in people with Stroke, run by Beijing Tiantan Hospital at 1 site in China.
Trial summary
The benefit-risk profile of thrombolysis for acute ischemic strokes beyond 24 hours has never been investigated. We initiated a multicenter, prospective, randomized, open label, blinded-endpoint (PROBE) controlled trial to assess the safety and efficacy of tenecteplase (0.25mg/kg, max 25mg) versus standard medical… 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 treatment
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 330 participants
- Where
- 1 siteChina
- Study dates
- 30 May 2025to 30 May 2027
- 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
- 1)Age ≥ 18 years old;
- 2)Acute ischemic stroke symptom onset between 24 to 72 hours prior to enrollment; including wake-up stroke and unwitnessed stroke, onset time refers to 'last-seen normal time';
- 3)Pre-stroke modified Rankin scale (mRS) score ≤1;
- 4)Baseline National Institutes of Health Stroke Scale (NIHSS) 6-25 (both inclusive) or a score of 4 or 5 with a disabling deficit (e.g., hemianopia, aphasia, and loss of hand function);
- 5)Neuroimaging:
- Middle cerebral artery M1-M4 occlusion, ACA, PCA or basilar artery occlusion confirmed by CTA/MRA, being responsible for signs and symptoms of acute ischemic stroke;
- target mismatch profile on CTP or MRI+PWI (ischemic core volume <70mL, mismatch ratio >1.2, and mismatch volume >10mL);
- 6)Written informed consent from patients or their legally authorized representatives.
Who cannot join
- 1)Present as a significant low-density lesion on CT
- 2)Allergy to tenecteplase
- 3)Rapidly improving symptoms at the discretion of the investigator
- 4)NIHSS consciousness score 1a >2, or epileptic seizure, hemiplegia after seizures (Todd's palsy) or other neurological/mental illness such that the patient is not able to cooperate or unwilling to cooperate
- 5)Persistent blood pressure elevation (systolic ≥185 mmHg or diastolic ≥110 mmHg), despite blood pressure-lowering treatment
- 6)Blood glucose <2.8 or >22.2 mmol/L (point of care glucose testing is acceptable)
Show all 19Show fewer
- 7)Active internal bleeding or at high risk of bleeding, e.g., major surgery, trauma or gastrointestinal or urinary tract hemorrhage within the previous 21 days, or arterial puncture at a non-compressible site within the previous 7 days
- 8)Any known impairment in coagulation due to comorbid disease or anticoagulant use. If on warfarin, then INR >1.7 or prothrombin time >15 seconds; use of any direct thrombin inhibitors or direct factor Xa inhibitors during the last 48 hours unless reversal of effect can be achieved with a reversal agent; any full dose heparin/heparinoid during the last 24 hours or with an aPTT greater than the upper limit of normal
- 9)Known defect of platelet function or platelet count below 100,000/mm3 (NB patients taking antiplatelet medication can be included)
- 10)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
- 11)Any terminal illness such that the patient would not be expected to survive more than 1 year
- 12)Unable to perform CTP or PWI
- 13)Hypodensity in >1/3 MCA territory on non-contrast CT for MCA occlusion, and pc-ASPECTS <6 for BAO
- 14)Acute or past intracerebral hemorrhage (ICH) identified by CT or MRI
- 15)Multiple arterial occlusion (bilateral MCA occlusion, MCA occlusion accompanied with basilar occlusion)
- 16)Pregnant women, nursing mothers, or reluctance to use effective contraceptive measures during the period of trial
- 17)Unlikely to adhere to the trial protocol or follow-up
- 18)Any condition that, in the judgment of the investigator could impose hazards to the patient if study therapy is initiated or affect the participation of the patient in the study
- 19)Participation in other interventional clinical trials within the previous 3 months
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, 100070
Yongjun Wang, 86-10-59978350, yongjunwang@ncrcnd.org.cn
About this study
Official title: Tenecteplase Reperfusion Therapy in Acute Ischemic Cerebrovascular Events-BEYOND--A Multicenter, Prospective, Randomized, Open Label, Blinded-endpoint (PROBE) Controlled Trial of Tenecteplase Versus Standard Medical Treatment for Acute Ischemic Stroke Due to Intracranial Vessel Occlusion With Perfusion Mismatch 24 to 72 Hours of Symptom Onset
The benefit-risk profile of thrombolysis for acute ischemic strokes beyond 24 hours has never been investigated. We initiated a multicenter, prospective, randomized, open label, blinded-endpoint (PROBE) controlled trial to assess the safety and efficacy of tenecteplase (0.25mg/kg, max 25mg) versus standard medical treatment in acute ischemic stroke due to intracranial vessel occlusion between 24-72 hours of symptom onset (including wake-up stroke and unwitnessed stroke).
Read the detailed description
Adult acute ischemic stroke patients due to middle cerebral artery M1-M4 occlusion, ACA, PCA or basilar artery occlusion confirmed by CTA/MRA with baseline National Institutes of Health Stroke Scale (NIHSS) 6-25 or a score of 4 or 5 with a disabling deficit (e.g., hemianopia, aphasia, and loss of hand function) will be enrolled in this trial. We use perfusion imaging to select subjects and the enrolled patients have target mismatch profile on CTP or MRI+PWI (ischemic core volume <70mL, mismatch ratio >1.2, and mismatch volume >10 mL). We will randomly assign patients who have salvageable brain tissue as identified on perfusion imaging to receive tenecteplase (at a dose of 0.25 mg per kilogram of body weight; maximum dose, 25 mg) or standard medical treatment 24 to 72 hours after the time that the patient was last known to be well (including after stroke on awakening and unwitnessed stroke). The primary outcome is the proportion of patients with an mRS score ≤ 1 at 90 days.
- Conditions
- Stroke
- Being tested
- Tenecteplase (0.25mg/kg), Standard medical treatment
- Keywords
- ischemic stroke, tenecteplase, beyond 24 hours
- Medical subject headings
- Stroke, Ischemic 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
Each vial of tenecteplase is reconstituted with 3 ml sterile water for injection and adjusted to a concentration of 5.33 mg/ml. Calculate the total amount of drug according to the subject's actual body weight and measure the required drug volume. The maximum dose should not exceed 25mg. Tenecteplase should be given as a single, intravenous bolus (within 5-10 seconds).
Standard medical treatmentDrug
Aspirin combined with clopidogrel, aspirin alone, or clopidogrel alone after randomization at the discretion of site researchers according to Chinese Guidelines for Diagnosis and Treatment of Acute Ischemic Stroke 2023.
| Study group | Role | What they receive |
|---|---|---|
| Tenecteplase (0.25 mg/kg) | Experimental | Tenecteplase (0.25 mg/kg, max 25 mg) Receives: Drug: Tenecteplase (0.25mg/kg) |
| Standard medical treatment | Active comparator | Aspirin combined with clopidogrel, aspirin alone, or clopidogrel alone, etc. Receives: Drug: Standard medical treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
mRS score ≤ 1 at 90 days
The proportion of patients with an mRS score ≤ 1 at 90 days
Measured: 90 days
Secondary outcomes (8)
mRS score
Ordinal distribution of mRS at 90 days (shift analysis)
Measured: 90 days
mRS score ≤ 2 at 90 days
The proportion of patients with an mRS score of 0-2
Measured: 90 days
early neurological improvement at 24h after randomization
The rate of early neurological improvement at 24h after randomization (defined as a NIHSS score ≤1 or ≥4 points compared with baseline)
Measured: 24 hours
improvement on reperfusion at 24h after randomization (anterior circulation)
The rate of improvement on reperfusion at 24h after randomization (improved by 90% on Tmax > 6s) for stroke with anterior circulation occlusions
Measured: 24 hours
complete recanalization at 24h after randomization
The rate of complete recanalization at 24h after randomization (defined as an AOL score of 3)
Measured: 24 hours
Symptomatic intracranial hemorrhage within 36 hours
Symptomatic intracranial hemorrhage within 36 hours (defined by the ECASS III criteria)
Measured: 36 hours
All-cause mortality at 90 days
All-cause mortality at 90 days
Measured: 90 days
Systemic bleeding at 90 days
Systemic bleeding at 90 days (defined by the GUSTO criteria: moderate and severe bleeding)
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2025
- Study start30 May 2025
- Primary completion28 Feb 2027 (estimated)
- Study completion30 May 2027 (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.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 330 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06954155
- Sponsor's protocol ID
- CSA2024YJ007
- Acronym
- TRACE-BEYOND
- Status last verified
- Mar 2026
- First submitted
- 24 Apr 2025
- Last updated
- 1 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tenecteplase Reperfusion Therapy in Acute Ischemic Cerebrovascular Events-BEYOND--A Multicenter, Prospective, Randomized, Open Label, Blinded-endpoint (PROBE) Controlled Trial of Tenecteplase Versus Standard Medical Treatment for Acute Ischemic Stroke Due to Intracranial Vessel Occlusion With Perfusion Mismatch 24 to 72 Hours of Symptom Onset
- ClinicalTrials.gov ID
- NCT06954155
- Acronym / sponsor ID
- TRACE-BEYOND / CSA2024YJ007
- Conditions
- Stroke
- Keywords
- ischemic stroke, tenecteplase, beyond 24 hours
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 330 participants (estimated)
- Lead sponsor
- Beijing Tiantan HospitalUniversity, hospital or other
- Study start
- 30 May 2025 (actual)
- Primary completion
- 28 Feb 2027 (estimated)
- Study completion
- 30 May 2027 (estimated)
- First posted
- 1 May 2025 (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 benefit-risk profile of thrombolysis for acute ischemic strokes beyond 24 hours has never been investigated. We initiated a multicenter, prospective, randomized, open label, blinded-endpoint (PROBE) controlled trial to assess the safety and efficacy of tenecteplase (0.25mg/kg, max 25mg) versus standard medical treatment in acute ischemic stroke due to intracranial vessel occlusion between 24-72 hours of symptom onset (including wake-up stroke and unwitnessed stroke).
Detailed description
Adult acute ischemic stroke patients due to middle cerebral artery M1-M4 occlusion, ACA, PCA or basilar artery occlusion confirmed by CTA/MRA with baseline National Institutes of Health Stroke Scale (NIHSS) 6-25 or a score of 4 or 5 with a disabling deficit (e.g., hemianopia, aphasia, and loss of hand function) will be enrolled in this trial. We use perfusion imaging to select subjects and the enrolled patients have target mismatch profile on CTP or MRI+PWI (ischemic core volume <70mL, mismatch ratio >1.2, and mismatch volume >10 mL). We will randomly assign patients who have salvageable brain tissue as identified on perfusion imaging to receive tenecteplase (at a dose of 0.25 mg per kilogram of body weight; maximum dose, 25 mg) or standard medical treatment 24 to 72 hours after the time that the patient was last known to be well (including after stroke on awakening and unwitnessed stroke). The primary outcome is the proportion of patients with an mRS score ≤ 1 at 90 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tenecteplase (0.25 mg/kg) | Experimental | Drug: Tenecteplase (0.25mg/kg)Tenecteplase (0.25 mg/kg, max 25 mg) |
| Standard medical treatment | Active comparator | Drug: Standard medical treatmentAspirin combined with clopidogrel, aspirin alone, or clopidogrel alone, etc. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 1)Age ≥ 18 years old;
- 2)Acute ischemic stroke symptom onset between 24 to 72 hours prior to enrollment; including wake-up stroke and unwitnessed stroke, onset time refers to 'last-seen normal time';
- 3)Pre-stroke modified Rankin scale (mRS) score ≤1;
- 4)Baseline National Institutes of Health Stroke Scale (NIHSS) 6-25 (both inclusive) or a score of 4 or 5 with a disabling deficit (e.g., hemianopia, aphasia, and loss of hand function);
- 5)Neuroimaging:
Key exclusion criteria (19 listed)
- 1)Present as a significant low-density lesion on CT
- 2)Allergy to tenecteplase
- 3)Rapidly improving symptoms at the discretion of the investigator
- 4)NIHSS consciousness score 1a >2, or epileptic seizure, hemiplegia after seizures (Todd's palsy) or other neurological/mental illness such that the patient is not able to cooperate or unwilling to cooperate
- 5)Persistent blood pressure elevation (systolic ≥185 mmHg or diastolic ≥110 mmHg), despite blood pressure-lowering treatment
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)Each vial of tenecteplase is reconstituted with 3 ml sterile water for injection and adjusted to a concentration of 5.33 mg/ml. Calculate the total amount of drug according to the subject's actual body weight and measure the required drug volume. The maximum dose should not exceed 25mg. Tenecteplase should be given as a single, intravenous bolus (within 5-10 seconds). | Drug | Tenecteplase (0.25 mg/kg) |
| Standard medical treatmentAspirin combined with clopidogrel, aspirin alone, or clopidogrel alone after randomization at the discretion of site researchers according to Chinese Guidelines for Diagnosis and Treatment of Acute Ischemic Stroke 2023. | Drug | Standard medical treatment |
Primary outcome
mRS score ≤ 1 at 90 days
Time frame: 90 days
The proportion of patients with an mRS score ≤ 1 at 90 days
8 secondary outcomes
mRS score
Time frame: 90 days
mRS score ≤ 2 at 90 days
Time frame: 90 days
early neurological improvement at 24h after randomization
Time frame: 24 hours
improvement on reperfusion at 24h after randomization (anterior circulation)
Time frame: 24 hours
complete recanalization at 24h after randomization
Time frame: 24 hours
Symptomatic intracranial hemorrhage within 36 hours
Time frame: 36 hours
All-cause mortality at 90 days
Time frame: 90 days
Systemic bleeding at 90 days
Time frame: 90 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 1 Apr 2026.
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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 Phase 3 study testing Tenecteplase (0.25mg/kg) and Standard medical treatment in people with 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 8 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 1 Apr 2026. 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?
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 (86-10-59978350, yongjunwang@ncrcnd.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
mRS score ≤ 1 at 90 days (time frame: 90 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 1 Apr 2026.