Tests tenecteplase against standard drugs for mild acute ischemic stroke
Tests intravenous tenecteplase in adults with mild acute ischemic stroke within 4.5 hours.
Key facts
- Who runs it
- Beijing Tiantan Hospital
- Where
- Beijing, ChinaSee the site
- Trial code
- Registry title
- Teneteplase Reperfusion Therapy in Acute Ischemic Cerebrovascular Events-Ⅳ
- Status
- Recruiting
- Phase
- Phase 3
- People taking part
- 1,386 people, planned
- Started
- 9 Jul 2025
- Planned end
- 31 Oct 2026
- Type of study
- Interventional, 2 groupsOne group gets a placebo (a dummy treatment), for comparison.
- Treatments tested
- rhTNK-tPA
- Control group (Aspirin combined with clopidogrel)
- Record updated
- 24 July 2025
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults who have just had a mild ischemic stroke with lasting weakness in one arm or leg, or speech problems, and who can be treated within 4.5 hours.
- Age
- 18 years or older
- Sex
- All sexes can join
- Disease stage
- Minor ischemic stroke with NIHSS score of 5 or less, and lasting weakness on one side of the body or speech problems. Treatment must start less than 4.5 hours after the person was last known well.
- Earlier treatment
- Cannot have had a stroke, serious head injury, or brain or spine surgery in the last 3 months. Cannot have used heparin in the last 24 hours, or thrombin or factor Xa inhibitors in the last 48 hours.
- Biomarker or test result
- Before the stroke, the person was mostly independent (mRS 0-1). Blood glucose must be between 2.8 and 22.2 mmol/L (50–400 mg/dL). Platelet count must be at least 100×10⁹/L.
Main reasons for not taking part
- Planned or likely clot-removal procedure before randomization
- History of bleeding in the brain, or bleeding on the head scan
- Large stroke on head CT or MRI, or very high blood pressure despite treatment
- Recent major surgery, or bleeding from the stomach, bowel or urinary tract
- Pregnant or breastfeeding women
The registry criteria, word for word
Show all 31 criteriaShow less
Who can take part
- Age ≥ 18 years
- Onset-to-treatment time < 4.5 h; onset time defined as "last known well" time
- Clinical diagnosis of minor ischemic stroke (NIHSS ≤ 5) with persistent unilateral limb weakness or speech symptoms, defined as a score of ≥1 on either the language item or a single limb item of the NIHSS
- Pre-stroke mRS 0-1
- Informed consent signed
Who cannot take part
- Severe head trauma or previous stroke within 3 months;
- Intracranial or spinal surgery within 3 months
- Major surgery within 2 weeks
- Use of thrombin inhibitors or factor Xa inhibitors within 48 hours
- Participation in another clinical trial within 3 months prior to screening
- Known allergic to rhTNK-tPA
- History of intracranial hemorrhage
- Gastrointestinal or urinary tract hemorrhage within 3 weeks;
- Intracranial hemorrhage, including intraparenchymal hemorrhage, intraventricular hemorrhage, subarachnoid hemorrhage, and subdural/epidural hematoma
- Active visceral bleeding
- Uncontrolled hypertension after active antihypertensive treatment: systolic blood pressure >180 mm Hg or diastolic >100 mm Hg
- Todd's paralysis after a seizure or other neurological/psychiatric disorders affecting cooperation
- Severe, uncontrolled infections (e.g., acute pericarditis, infective endocarditis, or acute pancreatitis)
- Other severe illnesses with a life expectancy of less than six months
- Acute bleeding tendency, including platelet count <100×10⁹/L or other clinically significant conditions
- Blood glucose < 2.8 or > 22.2 mmol / L
- Prior anticoagulant therapy, such as oral warfarin, with an INR >1.7 or PT >15 seconds
- Planned or likely acute endovascular treatments before randomization
- NIHSS 1a > 2
- Arterial puncture at a non-compressible site within 1 week;
- Intracranial tumors (excluding neuroectodermal tumors, e.g., meningiomas), large intracranial aneurysms, or arteriovenous malformations;
- Concomitantaortic arch dissection
- Use of heparin within 24 hours
- Large cerebral infarction on head CT or MRI (infarction area >1/3 of the middle cerebral artery territory)
- Pregnant or breastfeeding women, or women unwilling to use effective contraception during the study period
- Deemed unsuitable for the study or at increased risk by the investigator's judgment
Where in China
- Beijing Tiantan HospitalBeijing, ChinaContact: Yongjun Wang, Dr.Taking people
About the trial
What the trial wants to find out
The purpose of this study is to evaluate the efficacy and safety of intravenous tenecteplase (0.25 mg/kg) compared with standard therapy in patients with acute ischemic stroke presenting with mild symptoms-defined as a National Institutes of Health Stroke Scale (NIHSS) score ≤5 accompanied by persistent unilateral limb weakness or speech impairment within 4.5 hours of onset.
The 2 groups in the trial
- Aspirin combined with clopidogrelPlacebo, for comparison
Aspirin 100mg combined with clopidogrel 300mg, plus placebo intravenous rhTNK-tPA
Treatment: Control group (Aspirin combined with clopidogrel)
- rhTNK-tPA (0.25 mg/kg)Treatment being tested
rhTNK-tPA (0.25 mg/kg, max 25 mg) with placebo oral aspirin and clopidogrel
Treatment: rhTNK-tPA
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- TNK-tPA Treatment for Acute Minor Ischemic Stroke:A Randomized, Double-blind, Double-dummy Controlled Trial
- Plain-language title
- Tests tenecteplase against standard drugs for mild acute ischemic strokeGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Record updated
- 24 July 2025