Actively Recruiting
Teneteplase Reperfusion Therapy in Acute Ischemic Cerebrovascular Events-Ⅳ
Led by Beijing Tiantan Hospital · Updated on 2025-07-24
1386
Participants Needed
1
Research Sites
68 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Teneteplase Reperfusion Therapy in Acute Ischemic Cerebrovascular Events-Ⅳ
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Stroke symptoms started less than 4.5 hours ago
- Diagnosed with minor ischemic stroke (NIHSS score 5 or less) with persistent unilateral limb weakness or speech symptoms
- Modified Rankin Scale score 0-1 before stroke
- Signed informed consent
You will not qualify if you...
- Planned or expected acute endovascular treatment before randomization
- NIHSS item 1a score greater than 2
- Known allergy to rhTNK-tPA
- History of intracranial hemorrhage
- Severe head trauma or stroke within the last 3 months
- Intracranial or spinal surgery within 3 months
- Gastrointestinal or urinary tract bleeding within 3 weeks
- Major surgery within 2 weeks
- Arterial puncture at a non-compressible site within 1 week
- Intracranial tumors, large aneurysms, or arteriovenous malformations
- Any intracranial hemorrhage including various types
- Active visceral bleeding
- Aortic arch dissection
- Acute bleeding tendency or low platelet count
- Uncontrolled high blood pressure after treatment (systolic >180 mm Hg or diastolic >100 mm Hg)
- Blood glucose less than 2.8 or greater than 22.2 mmol/L
- Prior anticoagulant therapy with abnormal INR or PT
- Use of heparin within 24 hours
- Use of thrombin or factor Xa inhibitors within 48 hours
- Large cerebral infarction on imaging
- Todd's paralysis or neurological/psychiatric disorders affecting cooperation
- Severe uncontrolled infections
- Pregnant or breastfeeding women or unwilling to use contraception
- Participation in another clinical trial within 3 months
- Severe illness with life expectancy under six months
- Deemed unsuitable or at increased risk by investigator judgment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Beijing Tiantan Hospital
Beijing, Beijing Municipality, China
Actively Recruiting
Research Team
Y
Yongjun Wang, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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