Tenecteplase treatment for ischemic stroke between 24 and 72 hours after symptom onset

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 multicenter, randomized, open-label trial with blinded outcome adjudication enrolls adults with intracranial vessel occlusion and salvageable brain tissue on perfusion imaging 24–72 hours after last known well. Eligible patients have an NIHSS of 6–25 (or 4–5 with a disabling deficit) and a target mismatch profile on CTP or MRI perfusion. Participants are randomly assigned to a single IV bolus of tenecteplase (0.25 mg/kg, max 25 mg) or standard medical treatment. The primary outcome is the proportion of patients with a modified Rankin Scale score of 0–1 at 90 days.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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:

  1. 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;
  2. 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.

Exclusion Criteria:

* 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)
* 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

Where it's running

• Beijing tiantan hospital
  Beijing, China Recruiting

Study contacts

• Study coordinator: Yongjun Wang
• Email: yongjunwang@ncrcnd.org.cn
• 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.