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

• Status: Active, not recruiting
• Trial end date: 2022-05-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Beijing Tiantan Hospital
• Collaborators: Jiangsu FENG HUA Biotech Pharmaceutical Co., Ltd; The Place Pharmaceutical(Jiangsu) Co., Ltd
• Treatments: Tenecteplase; Tissue Plasminogen Activator

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.