Using Tenecteplase for Stroke Treatment Between 4.5 to 6 Hours After 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 study investigates the efficacy and safety of intravenous tenecteplase (TNK) for patients experiencing acute ischemic stroke (AIS) within a time frame of 4.5 to 6 hours from symptom onset. The research aims to extend the current treatment window for thrombolysis, which is typically limited to 4.5 hours, by evaluating the outcomes of patients treated with TNK during this extended period. Participants will be assessed for eligibility based on specific criteria, including age, stroke confirmation via imaging, and neurological assessment. The study seeks to determine whether TNK can provide benefits in terms of safety and effectiveness for this patient population.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age ≥ 18 year
* Acute ischemic stroke confirmed by non-contrast computed tomography and use of CTA for assessment of LVO as determined by local investigators;
* The time from last known well to treatment: 4.5 - 6 hours;
* NIHSS ≥ 4 at randomization;
* First stroke onset or past stroke without obvious neurological deficit (mRS≤1);
* Uncertainty over the benefits and risks of thrombolysis by researcher;
* Signed informed consent.

Exclusion Criteria:

* Pre-stroke disability (mRS≥2);
* Planned intravenous thrombolysis based on WAKE-UP or EXTEND study criterion;
* Any contraindication to intravenous thrombolysis: Obvious head injury or stroke within 3 months; Subarachnoid or intracranial hemorrhage; History of intracranial hemorrhage; Intracranial tumor, arteriovenous malformation or aneurysm; Intracranial or spinal cord surgery within 3 months; Myocardial infarction within 3 months; Major surgery within 1 month; Gastrointestinal or urinary tract hemorrhage within the previous 30 days; Arterial puncture at a noncompressible site within the previous seven days; Active internal hemorrhage; Coagulation abnormalities: platelet count of \<100000/mm3; Aortic arch dissection; Heparin therapy within 24 hours; Infective endocarditis; Oral warfarin is being taken and INR\>1.6 or APTT abnormal; Systolic pressure ≥185 mmHg or diastolic pressure ≥110 mmHg; Blood glucose \< 50 mg/dl (2.7mmol/L); Neurological deficit after epileptic seizures;
* Pregnancy;
* Allergy to test drugs;
* Comorbidity with other serious diseases;
* Participating in other clinical trials within 3 months;
* Patients not suitable for the study considered by researcher.

Where it's running

• Hui-Sheng Chen
  Shenyang, None Selected, China Recruiting
• Department of Neurology, General Hospital of Northern Theater Command
  Shenyang, China Recruiting

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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.