Thrombolysis Treated With TNK-tPA in Acute Ischemic Stroke Patients （3T Stroke-II）
- Registration Number
- NCT05281549
- Lead Sponsor
- Beijing Tiantan Hospital
- Brief Summary
The trial is prospective, block randomized, open-label, blinded endpoint (PROBE) design. Patients with acute ischemic stroke, who are eligible for standard intravenous thrombolysis within 4.5 hours of stroke onset will be randomized 1:1:1 to 0.25mg/kg or 0.40mg/kg intravenous tenecteplase or 0.9 mg/kg alteplase before all participants undergo endovascular thrombectomy.
- Detailed Description
The study will be a multi-center, prospective, randomized, open- label, blinded endpoint (PROBE), controlled phase 2 trial (3 arm with 1:1:1 randomization) in ischemic stroke patients. Imagine is performed with CT or MRI acutely with imaging follow-up at 24-30 hours. The sample size is 225.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 225
- Age ≥18 years old;
- The clinical diagnosis was Acute ischemic stroke 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";
- mRS before onset was ≤1 points;
- Baseline NIHSS (at the time of randomization) should be > 5 and ≤25 points;
- Informed consent from the patient or surrogate.
- Intracranial hemorrhage identified by CT or MRI (CMBs detected by SWI is not counted);
- Massive anterior cerebral infarction identified by CT or MRI (ASPECT < 6 or lesions larger than one third of the territory of the middle cerebral artery or with a volume larger than 70mL)
- A history of severe CNS damage (such as aneurysm or arteriovenous malformation, craniocerebral trauma, intracranial or spinal cord surgery)
- Onset with seizures, and the paralysis was suspected to be related to Todd paralysis.
- Administration of heparin within 48 hours preceding the onset of stroke with a baseline APTT exceeding the upper limit of the normal range.
- Oral anticoagulant (such as warfarin) treatment with baseline INR>1.7 or PT>15 s;
- Administration of thrombin inhibitors or factor Xa inhibitors within 48 hours preceding the onset of stroke with abnormal coagulation parameters or platelet count;
- BP couldn't be controlled with aggressive treatment. Uncontrolled hypertension was defined as systolic blood pressure >185 mmHg or diastolic blood pressure >110 mmHg, measured for three times every 10 minutes.
- Platelet count of less than 100×109/ L;
- Blood glucose <50 mg/dl (<2.8 mmol/L) or >400 mg/dl (22.22 mmol/L);
- History of intracranial hemorrhage or active hemorrhagic disease. (Such as gastrointestinal, urinary tract or retinal bleeding)
- Tumors with an increased risk of bleeding.
- Prolonged or traumatic cardiopulmonary resuscitation (>2 min), delivery within the last 10 days or recent puncture of non-compression vessels such as subclavian vein or jugular vein
- Acute pancreatitis or severe liver disease, including liver failure, cirrhosis, portal hypertension, esophageal varicose veins, and active hepatitis;
- Aortic arch dissection;
- Major surgery or severe trauma in the past 2 weeks;
- Subjects had serious, fatal, or disabling disease with an expected survival of less than 3 months;
- Unable to complete neurological assessment and follow-up visits because of dementia or mental illness;
- Pregnant women, lactating women, or have positive pregnancy test;
- Allergy to tenecteplase or alteplase or their components;
- Participation in other clinical trials within 3 months prior to screening;
- Unsuitable to involve in this study or would result in increased risk, as judged by the investigators.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Alteplase Alteplase Patients will receive intravenous Alteplase at the standard licensed dose of 0.9 mg/kg up to a maximum of 90mg, 10% as bolus and the remainder over 1 hour. Tenecteplase 0.25mg/kg Tenecteplase Patients will receive intravenous Tenecteplase, 0.25mg/kg, maximum 25mg, administered as a bolus over 5\~10 seconds Tenecteplase 0.4mg/kg Tenecteplase Patients will receive intravenous Tenecteplase, 0.4mg/kg, maximum 40mg, administered as a bolus over 5\~10 seconds
- Primary Outcome Measures
Name Time Method Modified Rankin Scale(mRS) 90±7 days Proportion of subjects with mRS scores of (0-1) at 90±7 days.(Comments:The minimum and maximum values are from 0 to 6,and higher scores mean a worse outcome.)
- Secondary Outcome Measures
Name Time Method Modified Rankin Scale(mRS) 90±7 days mRS scores at 90±7 days.(Comments:The minimum and maximum values are from 0 to 6,and higher scores mean a worse outcome.)
National Institutes of Health Stroke Scale (NIHSS) 7±2days or discharge Proportion of subjects with ≥ 4 point reduction in NIHSS or reaching 0-1 at 7 ± 2 days or before discharge (whichever occurs first).(Comments:The minimum and maximum values are from 0 to 40, and higher scores mean a worse outcome.)
The new vascular events 90±7 days Incidence of the new vascular events, ischemic stroke, hemorrhagic stroke, myocardial infarction and cardio-cerebral revascularization at 90±7 days. (including: carotid endarterectomy, intracranial and extracranial artery interventional therapy, intracranial and extracranial artery bypass surgery, coronary interventional or bypass therapy)
Deaths 90±7 days Vascular mortality at 90±7 days (mainly due to stroke, myocardial infarction or pulmonary embolism)
EQ-5D 90±7 days EQ-5D scores at 90±7 days.(Comments:The minimum and maximum values are from 0 to 100,and higher scores mean a better outcome.)
Trial Locations
- Locations (28)
Huai'an Second People's Hospital
🇨🇳Huai'an, Jiangsu, China
Tangshan Gongren Hospital
🇨🇳Tangshan, Hebei, China
Mei He Kou Central Hospital
🇨🇳Meihekou, Jilin, China
Shanghai Pudong Hospital
🇨🇳Shanghai, Shanghai, China
The First People's Hospital of Yinchuan
🇨🇳Yinchuan, Ningxia, China
Zhejiang Provincial People'S Hospital
🇨🇳Hangzhou, Zhejiang, China
Hengshui people's Hospital (Harrison International Peace Hospital)
🇨🇳Hengshui, Hebei, China
The Affiliated Hospital of Xuzhou Meidcal University
🇨🇳Xuzhou, Jiangsu, China
Beijing Tiantan Hospital, Capital Medical University Beijing
🇨🇳Beijing, Beijing, China
Jilin Guowen Hospital
🇨🇳Siping, Jilin, China
Baogang Hospital of Inner Monglia
🇨🇳Baotou, Inner Monglia, China
Linyi City People Hospital
🇨🇳Linyi, Shandong, China
General Hospital of Ningxia Medical University
🇨🇳Yinchuan, Ningxia, China
Yantai Yuhangding Hospital
🇨🇳Yantai, Shandong, China
Changzhi People'S Hospital
🇨🇳Changzhi, Shanxi, China
Zigong First People'S Hospital
🇨🇳Zigong, Sichuan, China
Taizhou Hospital of Zhejiang Province
🇨🇳Taizhou, Zhejiang, China
Dazhu County People's Hospital
🇨🇳Dazhou, Sichuan, China
Quanzhou First Hospital
🇨🇳Quanzhou, Fujian, China
Yue Bei People'S Hospital
🇨🇳Shaoguan, Guangdong, China
Inner Mongolia Baotou Hospital
🇨🇳Baotou, Inner Mongolia, China
The First Hospital of Jilin University
🇨🇳Changchun, Jilin, China
Daqing Oilfield General Hospital
🇨🇳Daqing, Heilongjiang, China
Shandong Provincial Third Hospital
🇨🇳Jinan, Shandong, China
Liaocheng People'S Hospital
🇨🇳Liaocheng, Shandong, China
Qingdao Central Hospital
🇨🇳Qingdao, Shandong, China
The First People's Hospital of Jinzhong
🇨🇳Jinzhong, Shanxi, China
First Hospital of Shanxi Medical University
🇨🇳Taiyuan, Shanxi, China