Advancing Reperfusion Therapy for Ischemic Stroke (ARTS): Tenecteplase in Medium Vessel Occlusion (MeVO) for Acute Ischemic Stroke

NCT ID: NCT07047014

Last Updated: 2025-11-19

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 596 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-30
• Study Completion Date: 2027-06-30

Brief 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. 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). 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Tenecteplase (0.25 mg/kg)

Tenecteplase (0.25 mg/kg, max 25 mg)

Group Type: EXPERIMENTAL

Tenecteplase (0.25mg/kg)

Intervention Type: 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 treatment

Aspirin combined with clopidogrel, aspirin alone, or clopidogrel alone

Group Type: ACTIVE_COMPARATOR

Standard medical treatment

Intervention Type: DRUG

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.

Interventions

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).

Intervention Type: DRUG

Standard medical treatment

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.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• (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)Pre-stroke modified Rankin scale (mRS) score ≤1; (5)Baseline National Institutes of Health Stroke Scale (NIHSS) ≥6 or NIHSS 3-5 with disabling symptoms; (6)Neuroimaging criteria: Target mismatch profile on CT perfusion or MRI+MR perfusion (ischemic core volume <70mL, mismatch rate >1.2, mismatch volume >10mL); (7)Written informed consent from patients or their legally authorized representatives.

Exclusion Criteria

• (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); (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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

First Affiliated Hospital of Zhejiang University

OTHER

Sponsor Role: collaborator

Chinese Stroke Association

UNKNOWN

Sponsor Role: collaborator

Beijing Tiantan Hospital

OTHER

Sponsor Role: lead

Responsible Party

Yunyun Xiong

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ziqi Xu

Role: PRINCIPAL_INVESTIGATOR

First Affiliated Hospital of Zhejiang University

Yunyun Xiong

Role: PRINCIPAL_INVESTIGATOR

Beijing Tiantan Hospital

Locations

Beijing tiantan hospital

Beijing, Beijing Municipality, China

Site Status: NOT_YET_RECRUITING

Jiuquan city people's hospital

Jiuquan, Gansu, China

Site Status: RECRUITING

Xingtang People's Hospital

Shijiazhuang, Hebei, China

Site Status: RECRUITING

Jiyuan Traditional Chinese Medicine Hospital

Jiyuan, Henan, China

Site Status: RECRUITING

The first people hospital of lingbao

Lingbao, Henan, China

Site Status: RECRUITING

Hai'an People's Hospital

Nantong, Jiangsu, China

Site Status: RECRUITING

The First Affiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, China

Site Status: NOT_YET_RECRUITING

Countries

China

Central Contacts

Yunyun Xiong

Role: CONTACT

xiongyunyun@bjtth.org

86-10-59978350

Ziqi Xu

Role: CONTACT

zyxuziqi@zju.edu.cn

86-0571-87236666

Facility Contacts

Shibin Wen

Role: primary

guookai@qq.com

86-15989246362

Yanxin Wang

Role: primary

Bdaczfg@163.com

86-18633876653

Hongqin Yang

Role: primary

yhq19720828@126.com

86-13938170576

Wei Wu

Role: primary

1034881652@qq.com

86-15839824116

Xiaowei Xu

Role: primary

littletailxu@sina.com

86-13862704155

Other Identifiers

CSA2024YJ006

Identifier Type: -

Identifier Source: org_study_id