Status:
COMPLETED
Tenecteplase Reperfusion Therapy in Acute Ischemic Cerebrovascular Events-Ⅱ
Lead Sponsor:
Beijing Tiantan Hospital
Collaborating Sponsors:
CSPC Mingfule Pharmaceutical (Guangzhou) Co., Ltd.
Conditions:
Acute Ischemic Stroke
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 Altep...
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.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 12 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 15 2022
Estimated Enrollment :
1430 Patients enrolled
Trial Details
Trial ID
NCT04797013
Start Date
June 12 2021
End Date
July 15 2022
Last Update
January 17 2023
Active Locations (61)
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1
The first affiliated hospital of ustc
Hefei, Anhui, China, 230000
2
The people's hospltal of xuancheng city
Xuancheng, Anhui, China, 242000
3
Beijing luhe hospital capital medical university
Beijing, Beijing Municipality, China, 100000
4
Beijing Tiantan Hospital, Capital Medical University
Beijing, Beijing Municipality, China, 100000