Thrombolysis Treated With TNK-tPA in Acute Ischemic Stroke Patients （3T Stroke-II）

NCT ID: NCT05281549

Last Updated: 2022-03-31

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 225 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-02
• Study Completion Date: 2022-05-31

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.

Conditions

Acute Ischemic Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Alteplase

Intervention Type: DRUG

Alteplase 0.9mg/kg are being used.

Tenecteplase 0.25mg/kg

Patients will receive intravenous Tenecteplase, 0.25mg/kg, maximum 25mg, administered as a bolus over 5\~10 seconds

Group Type: EXPERIMENTAL

Tenecteplase

Intervention Type: DRUG

Tenecteplase 0.25mg/kg are being used.

Tenecteplase 0.4mg/kg

Patients will receive intravenous Tenecteplase, 0.4mg/kg, maximum 40mg, administered as a bolus over 5\~10 seconds

Group Type: EXPERIMENTAL

Tenecteplase

Intervention Type: DRUG

Tenecteplase 0.4mg/kg are being used.

Interventions

Alteplase

Alteplase 0.9mg/kg are being used.

Intervention Type: DRUG

Tenecteplase

Tenecteplase 0.25mg/kg are being used.

Intervention Type: DRUG

Tenecteplase

Tenecteplase 0.4mg/kg are being used.

Intervention Type: DRUG

Other Intervention Names

rt-PA; TNK-tPA; TNK-tPA

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jiangsu FENG HUA Biotech Pharmaceutical Co., Ltd

UNKNOWN

Sponsor Role: collaborator

The Place Pharmaceutical(Jiangsu) Co., Ltd

UNKNOWN

Sponsor Role: collaborator

Beijing Tiantan Hospital

OTHER

Sponsor Role: lead

Responsible Party

Yongjun Wang

President of Beijing Tiantan Hospital, Capital Medical University, Director of Neurology Center

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Shuya Li

Role: STUDY_DIRECTOR

IRB of Beijing Tiantan Hospital,Capital Medical University

Locations

Beijing Tiantan Hospital, Capital Medical University Beijing

Beijing, Beijing Municipality, China

Quanzhou First Hospital

Quanzhou, Fujian, China

Yue Bei People'S Hospital

Shaoguan, Guangdong, China

Hengshui people's Hospital (Harrison International Peace Hospital)

Hengshui, Hebei, China

Tangshan Gongren Hospital

Tangshan, Hebei, China

Daqing Oilfield General Hospital

Daqing, Heilongjiang, China

Baogang Hospital of Inner Monglia

Baotou, Inner Monglia, China

Inner Mongolia Baotou Hospital

Baotou, Inner Mongolia, China

Huai'an Second People's Hospital

Huai'an, Jiangsu, China

The Affiliated Hospital of Xuzhou Meidcal University

Xuzhou, Jiangsu, China

The First Hospital of Jilin University

Changchun, Jilin, China

Mei He Kou Central Hospital

Meihekou, Jilin, China

Jilin Guowen Hospital

Siping, Jilin, China

The First People's Hospital of Yinchuan

Yinchuan, Ningxia, China

General Hospital of Ningxia Medical University

Yinchuan, Ningxia, China

Shandong Provincial Third Hospital

Jinan, Shandong, China

Liaocheng People'S Hospital

Liaocheng, Shandong, China

Linyi City People Hospital

Linyi, Shandong, China

Qingdao Central Hospital

Qingdao, Shandong, China

Yantai Yuhangding Hospital

Yantai, Shandong, China

Shanghai Pudong Hospital

Shanghai, Shanghai Municipality, China

Changzhi People'S Hospital

Changzhi, Shanxi, China

The First People's Hospital of Jinzhong

Jinzhong, Shanxi, China

First Hospital of Shanxi Medical University

Taiyuan, Shanxi, China

Dazhu County People's Hospital

Dazhou, Sichuan, China

Zigong First People'S Hospital

Zigong, Sichuan, China

Zhejiang Provincial People'S Hospital

Hangzhou, Zhejiang, China

Taizhou Hospital of Zhejiang Province

Taizhou, Zhejiang, China

Countries

China

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Other Identifiers

PR-SMTJ-2019001F

Identifier Type: -

Identifier Source: org_study_id