Tenecteplase Reperfusion Therapy in Acute Ischemic Cerebrovascular Events-Ⅱ

Phase 3

Completed

• Conditions: Acute Ischemic Stroke
• Interventions: Drug: rhTNK-tPA; Drug: rt-PA

• 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.

Study Timeline

• Study First Submitted: 2021-02-25
• Study First Submitted QC: 2021-03-10
• Study First Posted: 2021-03-15
• Study Start: 2021-06-12
• Primary Completion: 2022-05-29
• Study Completion: 2022-07-15
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-13
• Last Update Posted: 2023-01-17

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

Group	Intervention	Description
rhTNK-tPA (0.25mg/kg)	rhTNK-tPA	rhTNK-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-PA	10% dose of rt-PA (0.9 mg/kg) is given as bolus and the remainder in 1 hour. Maximum dose 90mg.

Primary Outcome Measures

Name	Time	Method
Excellent functional outcome	90 days	Proportion of subjects with mRS(0-1) at 90 days.

Secondary Outcome Measures

Name	Time	Method
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 outcome	90 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-5D	90 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)