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Tenecteplase Reperfusion Therapy in Acute Ischemic Cerebrovascular Events-Ⅱ

Phase 3
Completed
Conditions
Acute Ischemic Stroke
Interventions
Registration Number
NCT04797013
Lead Sponsor
Beijing Tiantan Hospital
Brief Summary

A Phase Ⅲ, Multicenter, Prospective, Randomized, Open Label, Blinded-endpoint (PROBE) Controlled Trial of Recombinant Human TNK Tissue-type Plasminogen Activator (rhTNK-tPA) for Injection Versus Alteplase for Acute Ischemic Stroke Within 4.5 Hours

Detailed Description

To test the hypothesis that rhTNK-tPA is non-inferior to alteplase in thrombolysis treatment when administered within 4.5 hours of ischemic stroke onset.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
1430
Inclusion Criteria
  • Age ≥18 years old, no gender limitation;
  • The time from onset to treatment was < 4.5h;The time at which symptoms begin is defined as "the time at which they finally appear normal";
  • The clinical diagnosis was ischemic stroke (the diagnosis followed the Chinese Guidelines for the Diagnosis and Treatment of Acute Ischemic Stroke 2018);
  • MRS before onset was 0-1 points
  • Baseline NIHSS 5-25(both included);
  • Informed consent from the patient or surrogate.
Exclusion Criteria
  • Intended to proceed endovascular treatment;
  • NIHSS consciousness score >2;
  • Allergy to tenecteplase or alteplase;
  • Past history of intracranial hemorrhage ;
  • A history of severe head trauma or stroke within 3 months;
  • A history of intracranial or spinal surgery within 3 months;
  • A history of gastrointestinal or urinary bleeding within 3 weeks;
  • 2 weeks of major surgery;
  • Arterial puncture was performed at the hemostasis site that was not easily compressed within 1 week;
  • Intracranial tumors (except neuroectodermal tumors, such as meningiomas), large intracranial aneurysms;
  • Intracranial hemorrhage (including parenchymal hemorrhage, intraventricular hemorrhage, subarachnoid hemorrhage, subdural/extradural hematoma, etc.);
  • Active visceral bleeding;
  • Aortic arch dissection was found;
  • After active antihypertensive treatment, hypertension is still not under control: systolic blood pressure ≥180 mm Hg, or diastolic blood pressure ≥100 mm Hg;
  • Propensity for acute bleeding, including platelet counts of less than 100×109/ L or otherwise;
  • Blood glucose <2.8 mmol/L or >22.22 mmol/L;
  • Oral warfarin anticoagulant with INR>1.7 or PT>15 s;
  • Heparin treatment was received within 24 h;
  • Thrombin inhibitors or factor Xa inhibitors were used within 48 h;
  • Head CT or MRI showed a large infarction (infarcted area > 1/3 of the middle cerebral artery);
  • Subjects who are unable or unwilling to cooperate due to hemiplegia (Todd's palsy) after epileptic seizure or other neurological/psychiatric disorders;
  • Pregnant women, lactating women, or subjects who do not agree to use effective contraception during the trial;
  • Participation in other clinical trials within 3 months prior to screening;
  • Unsuitability or participation in this study as judged by the Investigator may result in subjects being exposed to greater risk.

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
rhTNK-tPA (0.25mg/kg)rhTNK-tPArhTNK-tPA (0.25mg/kg) is given as a single, intravenous bolus (within 5-10 seconds) immediately upon randomization. Maximum dose 25mg.
rt-PA (0.9mg/kg)rt-PA10% dose of rt-PA (0.9 mg/kg) is given as bolus and the remainder in 1 hour. Maximum dose 90mg.
Primary Outcome Measures
NameTimeMethod
Excellent functional outcome90 days

Proportion of subjects with mRS(0-1) at 90 days.

Secondary Outcome Measures
NameTimeMethod
National Institutes of Health Stroke Scale (NIHSS)24 hours,day7

Proportion of subjects with NIHSS score ≥ 4 improved compared with baseline at 24 or with NIHSS 0-1 at 24 hours and 7 days.

Barthel (BI)90 days

Global function of daily living defined as BI ≥ 95 at 90 days.

Good functional outcome90 days

Proportion of subjects with mRS(0-2) at 90 days.

Modified Rankin Scale(mRS)90 days

Ordinal distribution of mRS at 90 days.

EQ-5D90 days

Quality of life measured by EQ-5D scale.

Trial Locations

Locations (61)

The first affiliated hospital of ustc

🇨🇳

Hefei, Anhui, China

The people's hospltal of xuancheng city

🇨🇳

Xuancheng, Anhui, China

Beijing luhe hospital capital medical university

🇨🇳

Beijing, Beijing, China

Beijing Tiantan Hospital, Capital Medical University

🇨🇳

Beijing, Beijing, China

Chongqing Three Gorges Central Hospital

🇨🇳

Chongqing, Chongqing, China

The first hospital of lanzhou university

🇨🇳

Lanzhou, Gansu, China

Guangdong Provincial Hospital of Traditional Chinese Medicine

🇨🇳

Guangdong, Guangdong, China

Yue bei people's hospital

🇨🇳

Shaoguan, Guangdong, China

Guizhou provincial people's hospital

🇨🇳

Guiyang, Guizhou, China

Affiliated hospital of chengde medical university

🇨🇳

Chengde, Hebei, China

Scroll for more (51 remaining)
The first affiliated hospital of ustc
🇨🇳Hefei, Anhui, China

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