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New treatment option for Minor Ischemic Stroke
Official title Teneteplase Reperfusion Therapy in Acute Ischemic Cerebrovascular Events-Ⅳ
ClinicalTrials.gov ID: NCT06414499
What this study is testing
What is rhTNK-tPA?
rhTNK-tPA is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for minor ischemic stroke.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- Pre-stroke mRS 0-1;
- Informed consent signed.
You likely can't join if
- Planned or likely acute endovascular treatments before randomization;
- NIHSS 1a \> 2;
- Known allergic to rhTNK-tPA;
- History of intracranial hemorrhage;
- Severe head trauma or previous stroke within 3 months；
- Intracranial or spinal surgery within 3 months;
See the full eligibility criteria
- 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.
- Planned or likely acute endovascular treatments before randomization;
- NIHSS 1a \> 2;
- Known allergic to rhTNK-tPA;
- History of intracranial hemorrhage;
- Severe head trauma or previous stroke within 3 months；
- Intracranial or spinal surgery within 3 months;
- Gastrointestinal or urinary tract hemorrhage within 3 weeks；
- Major surgery within 2 weeks;
- Arterial puncture at a non-compressible site within 1 week；
- Intracranial tumors (excluding neuroectodermal tumors, e.g., meningiomas), large intracranial aneurysms, or arteriovenous malformations；
- Intracranial hemorrhage, including intraparenchymal hemorrhage, intraventricular hemorrhage, subarachnoid hemorrhage, and subdural/epidural hematoma;
- Active visceral bleeding;
- Concomitantaortic arch dissection;
- Acute bleeding tendency, including platelet count \<100×10⁹/L or other clinically significant conditions;
- Uncontrolled hypertension after active antihypertensive treatment: systolic blood pressure \>180 mm Hg or diastolic \>100 mm Hg;
- Blood glucose \ 22.2 mmol / L;
- Prior anticoagulant therapy, such as oral warfarin, with an INR \>1.7 or PT \>15 seconds;
- Use of heparin within 24 hours;
- Use of thrombin inhibitors or factor Xa inhibitors within 48 hours;
- Large cerebral infarction on head CT or MRI (infarction area \>1/3 of the middle cerebral artery territory);
- 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);
- Pregnant or breastfeeding women, or women unwilling to use effective contraception during the study period;
- Participation in another clinical trial within 3 months prior to screening;
- Other severe illnesses with a life expectancy of less than six months;
- Deemed unsuitable for the study or at increased risk by the investigator's judgment.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.