Actively Recruiting

Phase 3
Age: 18Years +
All Genders
NCT06414499

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

1
2
3
+1

Trial Site Locations

Total: 1 location

1

Beijing Tiantan Hospital

Beijing, Beijing Municipality, China

Actively Recruiting

Loading map...

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

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here

Teneteplase Reperfusion Therapy in Acute Ischemic Cerebrovascular Events-Ⅳ | DecenTrialz