Stroke, IschemicPhase 3ARTS-MeVONCT07047014
Advancing Reperfusion Therapy for Ischemic Stroke (ARTS): Tenecteplase in Medium Vessel Occlusion (MeVO) for Acute Ischemic Stroke
A Phase 3 study testing Tenecteplase (0.25mg/kg) and Standard medical treatment in people with Stroke, Ischemic and Medium Vessel Occlusions, run by Beijing Tiantan Hospital at 7 sites in China.
Trial summary
Results from recent several trials provided data showing limits to the effectiveness of thrombectomy for ischemic stroke due to medium vessel occlusions.The benefit-risk profile of thrombolysis for these patients has never been investigated. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Ischemic, Medium Vessel Occlusions
- 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
- 596 participants
- Where
- 7 sitesChina
- Study dates
- 30 Jul 2025to 30 Jun 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 within 4.5 - 24 hours; including wake-up stroke and unwitnessed stroke, onset time refers to "last-seen normal time";
- (3)Primary medium vessel occlusions confirmed by CTA/MRA, including distal M2/M3 segments of the middle cerebral artery (MCA), A1/A2/A3 segments of the anterior cerebral artery (ACA), and P1/P2/P3 segments of the posterior cerebral artery (PCA) and responsible for the signs and symptoms of acute ischemic stroke;
- (4)Neuroimaging criteria: a) Perfusion criteria:Target mismatch profile on CT perfusion or MRI+MR perfusion (ischemic core volume <70mL, mismatch ratio >1.2, mismatch volume >10mL); b) If neither MRI or CT perfusion is available at the site : an Alberta Stroke Program Early CT Score [ASPECTS] of 8 or more on NCCT /MRI-DWI or PC-ASPECTS of 8 or more on NCCT/MRI-DWI.
- (5)Pre-stroke modified Rankin scale (mRS) score ≤1;
- (6)Baseline National Institutes of Health Stroke Scale (NIHSS) ≥6 or NIHSS 3-5 with disabling symptoms;
- (7)Written informed consent from patients or their legally authorized representatives.
Who cannot join
- (1)Allergy to tenecteplase;
- (2)Rapidly improving symptoms at the discretion of the investigator;
- (3)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;
- (4)Intention to undergo endovascular treatment.
- (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);
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- (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 dabigatran can be achieved with idarucizumab; 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 or hypodensity outside the current perfusion lesion suggesting distal clot migration (secondary MeVO);
- (14)Acute or past intracerebral hemorrhage (ICH) identified by CT or MRI;
- (15)Pregnant women, nursing mothers, or reluctance to use effective contraceptive measures during the period of the trial;
- (16)Unlikely to adhere to the trial protocol or follow-up;
- (17) Participation in other interventional clinical trials within the previous 3 months.
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
China7 sites, 7 recruiting
- Not yet recruiting
Beijing tiantan hospital
Beijing, Beijing Municipality, 100070
- Not yet recruiting
The First Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, 310003
- Recruiting
Jiuquan city people's hospital
Jiuquan, Gansu, 736100
Shibin Wen, 86-15989246362, guookai@qq.com
- Recruiting
Jiyuan Traditional Chinese Medicine Hospital
Jiyuan, Henan, 459000
Hongqin Yang, 86-13938170576, yhq19720828@126.com
- Recruiting
The first people hospital of lingbao
Lingbao, Henan, 472500
Wei Wu, 86-15839824116, 1034881652@qq.com
- Recruiting
Hai'an People's Hospital
Nantong, Jiangsu, 226600
Xiaowei Xu, 86-13862704155, littletailxu@sina.com
- Recruiting
Xingtang People's Hospital
Shijiazhuang, Hebei, 050600
Yanxin Wang, 86-18633876653, Bdaczfg@163.com
About this study
Results from recent several trials provided data showing limits to the effectiveness of thrombectomy for ischemic stroke due to medium vessel occlusions.The benefit-risk profile of thrombolysis for these patients has never been investigated. We initiated a multicenter, prospective, randomized, open label, blinded-endpoint (PROBE) controlled trial to evaluate the efficacy and safety of tenecteplase (0.25mg/kg, maximum dose 25mg) compared to standard medical care for patients with acute ischemic stroke due to medium vessel occlusion (MeVO) within 4.5 to 24 hours from symptom onset.
Read the detailed description
Adult acute ischemic stroke patients due to primary medium vessel occlusions (distal M2/M3 segments of the middle cerebral artery, A1/A2/A3 segments of the anterior cerebral artery, and P1/P2/P3 segments of the posterior cerebral artery confirmed by CTA/MRA, and responsible for the signs and symptoms of acute ischemic stroke) with baseline National Institutes of Health Stroke Scale (NIHSS) ≥6 or NIHSS 3-5 with disabling symptoms 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, mismatch volume >10mL). If neither MRI or CT perfusion is available at the site, an ASPECTS/PC-ASPECTS of 8 or more on NCCT /MRI-DWI will be used.We will randomly assign eligible patients to receive tenecteplase (at a dose of 0.25 mg per kilogram of body weight; maximum dose, 25 mg) or standard medical treatment 4.5 to 24 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, Ischemic, Medium Vessel Occlusions
- Being tested
- Tenecteplase (0.25mg/kg), Standard medical treatment
- Keywords
- ischemic stroke, tenecteplase, medium vessel occlusions, beyond 4.5 hours
- Medical subject headings
- 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 (10)
mRS score
Ordinal distribution of mRS at 90 days (shift analysis)
Measured: 90 days
mRS score ≤ 2
The proportion of patients with an mRS score of 0-2 at 90 days
Measured: 90 days
Early neurological improvement
The rate of early neurological improvement at 24h after randomization (defined as a NIHSS score ≤1 or ≥4 points compared with the baseline)
Measured: 24 hours
mRS 5-6
mRS 5-6 at 90 days
Measured: 90 days
EuroQol 5-Dimension (EQ-5D) index
EuroQol 5-Dimension (EQ-5D) index at 90 days and 1 year
Measured: 90 days and 1 year
mRS score at 1 year
mRS score at 1 year
Measured: 1 year
Symptomatic intracranial hemorrhage
Symptomatic intracranial hemorrhage within 36 hours (defined by the SITS-MOST criteria)
Measured: 36 hours
All-cause mortality
All-cause mortality at 90 days and 1 year
Measured: 90 days and 1 year
Systemic bleeding
Systemic bleeding at 90 days (defined by the GUSTO criteria: moderate and severe bleeding)
Measured: 90 days
Adverse events (AEs)/ serious adverse events (SAEs)
Adverse events (AEs)/ serious adverse events (SAEs) within 90 days
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 posted2 Jul 2025
- Study start30 Jul 2025
- Primary completion30 Mar 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
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.
- 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
- 596 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Tiantan Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- First Affiliated Hospital of Zhejiang University, Chinese Stroke Association
- Responsible party
- Principal investigator, Yunyun Xiong, Beijing Tiantan Hospital
- Investigators
- Ziqi Xu, Principal investigator, First Affiliated Hospital of Zhejiang UniversityYunyun Xiong, Principal investigator, Beijing Tiantan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07047014
- Sponsor's protocol ID
- CSA2024YJ006
- Acronym
- ARTS-MeVO
- Status last verified
- Mar 2026
- First submitted
- 24 Jun 2025
- Last updated
- 1 Apr 2026
- 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 1 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Advancing Reperfusion Therapy for Ischemic Stroke (ARTS): Tenecteplase in Medium Vessel Occlusion (MeVO) for Acute Ischemic Stroke
- ClinicalTrials.gov ID
- NCT07047014
- Acronym / sponsor ID
- ARTS-MeVO / CSA2024YJ006
- Conditions
- Stroke, Ischemic, Medium Vessel Occlusions
- Keywords
- ischemic stroke, tenecteplase, medium vessel occlusions, beyond 4.5 hours
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 596 participants (estimated)
- Lead sponsor
- Beijing Tiantan HospitalUniversity, hospital or other
- Collaborators
- First Affiliated Hospital of Zhejiang University, Chinese Stroke Association
- Study start
- 30 Jul 2025 (actual)
- Primary completion
- 30 Mar 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 2 Jul 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.
Results from recent several trials provided data showing limits to the effectiveness of thrombectomy for ischemic stroke due to medium vessel occlusions.The benefit-risk profile of thrombolysis for these patients has never been investigated. We initiated a multicenter, prospective, randomized, open label, blinded-endpoint (PROBE) controlled trial to evaluate the efficacy and safety of tenecteplase (0.25mg/kg, maximum dose 25mg) compared to standard medical care for patients with acute ischemic stroke due to medium vessel occlusion (MeVO) within 4.5 to 24 hours from symptom onset.
Detailed description
Adult acute ischemic stroke patients due to primary medium vessel occlusions (distal M2/M3 segments of the middle cerebral artery, A1/A2/A3 segments of the anterior cerebral artery, and P1/P2/P3 segments of the posterior cerebral artery confirmed by CTA/MRA, and responsible for the signs and symptoms of acute ischemic stroke) with baseline National Institutes of Health Stroke Scale (NIHSS) ≥6 or NIHSS 3-5 with disabling symptoms 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, mismatch volume >10mL). If neither MRI or CT perfusion is available at the site, an ASPECTS/PC-ASPECTS of 8 or more on NCCT /MRI-DWI will be used.We will randomly assign eligible patients to receive tenecteplase (at a dose of 0.25 mg per kilogram of body weight; maximum dose, 25 mg) or standard medical treatment 4.5 to 24 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 (7 listed)
- (1)Age≥18 years old;
- (2)Acute ischemic stroke symptom onset within 4.5 - 24 hours; including wake-up stroke and unwitnessed stroke, onset time refers to "last-seen normal time";
- (3)Primary medium vessel occlusions confirmed by CTA/MRA, including distal M2/M3 segments of the middle cerebral artery (MCA), A1/A2/A3 segments of the anterior cerebral artery (ACA), and P1/P2/P3 segments of the posterior cerebral artery (PCA) and responsible for the signs and symptoms of acute ischemic stroke;
- (4)Neuroimaging criteria: a) Perfusion criteria:Target mismatch profile on CT perfusion or MRI+MR perfusion (ischemic core volume <70mL, mismatch ratio >1.2, mismatch volume >10mL); b) If neither MRI or CT perfusion is available at the site : an Alberta Stroke Program Early CT Score [ASPECTS] of 8 or more on NCCT /MRI-DWI or PC-ASPECTS of 8 or more on NCCT/MRI-DWI.
- (5)Pre-stroke modified Rankin scale (mRS) score ≤1;
Key exclusion criteria (17 listed)
- (1)Allergy to tenecteplase;
- (2)Rapidly improving symptoms at the discretion of the investigator;
- (3)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;
- (4)Intention to undergo endovascular treatment.
- (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
10 secondary outcomes
mRS score
Time frame: 90 days
mRS score ≤ 2
Time frame: 90 days
Early neurological improvement
Time frame: 24 hours
mRS 5-6
Time frame: 90 days
EuroQol 5-Dimension (EQ-5D) index
Time frame: 90 days and 1 year
mRS score at 1 year
Time frame: 1 year
Symptomatic intracranial hemorrhage
Time frame: 36 hours
All-cause mortality
Time frame: 90 days and 1 year
Systemic bleeding
Time frame: 90 days
Adverse events (AEs)/ serious adverse events (SAEs)
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.
- 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.
Ziqi Xu principal investigator
First Affiliated Hospital of Zhejiang University
Yunyun Xiong principal investigator
Beijing Tiantan Hospital
7 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 treatment in people with Stroke, Ischemic and Medium Vessel Occlusions, run by Beijing Tiantan Hospital at 7 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 17 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 7 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 Yunyun Xiong (86-10-59978350, xiongyunyun@bjtth.org), 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; AzTrials last refreshed its copy on 2 Nov 2026.