Tenecteplase for adults with medium-vessel ischemic stroke treated 4.5–24 hours after last seen well

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a multicenter, randomized, open-label, blinded-endpoint (PROBE) trial comparing tenecteplase (0.25 mg/kg, max 25 mg) to standard medical care for acute ischemic stroke caused by medium vessel occlusions treated 4.5–24 hours after last known well. Eligible adults must have a primary medium-vessel occlusion confirmed by CTA/MRA and either a target perfusion mismatch on CTP or MRI/PWI (core <70 mL, mismatch ratio >1.2, mismatch volume >10 mL) or an ASPECTS/PC-ASPECTS ≥8 if perfusion is unavailable. Patients are randomized to receive tenecteplase or standard care and followed for clinical outcomes, with the primary endpoint being the proportion with a modified Rankin Scale score ≤1 at 90 days. The trial is led by Beijing Tiantan Hospital with multiple Chinese hospital sites participating.

Why it matters

Who can join: the full rules

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)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.

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.

Where it's running

• Jiuquan city people's hospital
  Jiuquan, Gansu, China Recruiting
• Xingtang People's Hospital
  Shijiazhuang, Hebei, China Recruiting
• Jiyuan Traditional Chinese Medicine Hospital
  Jiyuan, Henan, China Recruiting
• The first people hospital of lingbao
  Lingbao, Henan, China Recruiting
• Hai'an People's Hospital
  Nantong, Jiangsu, China Recruiting
• Beijing tiantan hospital
  Beijing, Beijing Municipality, China Not yet recruiting

Study contacts

• Principal investigator: Ziqi Xu — First Affiliated Hospital of Zhejiang University
• Study coordinator: Yunyun Xiong
• Email: xiongyunyun@bjtth.org
• Phone: 86-10-59978350

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.