NCT07540416Not yet recruitingPhase 3
Tenecteplase for Late-Window Stroke Guided by DWI-FLAIR Mismatch
Tenecteplase Thrombolysis for Acute Ischemic Stroke in the 4.5-9-Hour Window Guided by DWI-FLAIR Mismatch: A Multicenter, Prospective, Randomized, Double-Blind, Placebo-Controlled Trial
Source: ClinicalTrials.gov · Last updated 20 Apr 2026
Brief summary (registry, in English)
The goal of this clinical trial is to evaluate the efficacy and safety of tenecteplase administered 4.5-9 hours after stroke onset (defined as the time the patient was first found with symptoms, including wake-up stroke and unwitnessed stroke) in patients with acute ischemic stroke (AIS) guided by DWI-FLAIR mismatch on MRI. The main questions it aims to answer are: 1. Does tenecteplase improve functional outcomes at 90 days compared with standard treatments in AIS patients administered 4.5-9 hours after stroke onset guided by DWI-FLAIR mismatch? 2. The safety of tenecteplase thrombolysis for AIS patients in the 4.5-9 hours guided by DWI-FLAIR mismatch. Researchers will compare tenecteplase to placebo to see if it is effective and safe for these patients. Participants will be randomly assigned (1:1) immediately after randomization: * Tenecteplase group: received tenecteplase, intravenously as a bolus administered over a period of 5 to 10 seconds at a dose of 0.25 mg per kilogram (maximum dose, 25 mg), plus aspirin placebo (300 mg). * Control group: aspirin (300 mg) plus tenecteplase placebo. From day 2 to day 90, all patients will be conformed to the 2023 Chinese Guidelines for Diagnosis and Treatment of Acute Ischemic Stroke.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 564 (estimated)
- First submitted
- 6 Apr 2026
- Start date
- 1 May 2026
- Primary completion date
- 31 Dec 2027
- Lead sponsor
- The First Affiliated Hospital of Zhengzhou University
- Diseases
- Stroke
- NCT number
- NCT07540416
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 564
- From 1 May 2026 to the primary completion date, 31 Dec 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Intracranial or spinal cord surgery within 3 months;
- Heparin therapy within 24 hours;
- Oral anticoagulation therapy;
- Major surgery within 1 month;
- Gastrointestinal or urinary tract hemorrhage within the previous 30 days;
- Participation in other interventional clinical trials within the previous 3 months.
Other illness
- Subarachnoid or intracranial hemorrhage;
- History of intracranial hemorrhage;
- Active internal hemorrhage;
- Neurological deficit after epileptic seizures;
- Myocardial infarction within 3 months;
- Allergy to study drugs;
- 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;
Lab values
- platelet count of \<100000/mm3;
- Oral warfarin is being taken and INR\>1.6 or APTT abnormal;
- Blood glucose \< 50 mg/dl (2.7mmol/L);
Other
- Planned endovascular treatment;
- Contradictory to MRI examination;
- MRI image not qualified for evaluation;
- Serious neurological deficits before onset (mRS≥2);
- Obvious head injuries or strokes within 3 months;
- Intracranial tumor, arteriovenous malformation or aneurysm;
- Aortic arch dissection;
- Systolic pressure≥185 mmHg or diastolic pressure≥110 mmHg;
- Pregnancy;
- Unlikely to adhere to the trial protocol or follow-up;
Who the study is looking for
- Age ≥ 18 years;
- AIS with symptom onset 4.5-9 hours before enrollment, including wake-up stroke and unwitnessed stroke (onset time defined as when symptoms were first noticed);
- Imaging criteria:
- DWI-FLAIR mismatch: visible lesion on DWI with no marked visible lesion on FLAIR;
- DWI infarct core not exceeding one-third of the middle cerebral artery territory, one-half of the anterior cerebral artery territory, or one-half of the posterior cerebral artery territory;
- NIHSS score 4-25;
- First-ever stroke or previous stroke without significant disability (pre-stroke mRS ≤ 1);
- Signed informed consent from the patient or legally authorized representative.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The First Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan Coordinator of this site? Confirm its status | Zhengzhou | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.