Thrombolysis Treated With TNK-tPA in Acute Ischemic Stroke Patients （3T Stroke-II）
Status and phase
Conditions
Treatments
Details and patient eligibility
About
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.
Full 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.
Enrollment
Sex
Ages
Volunteers
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.
Trial design
Primary purpose
Allocation
Interventional model
Masking
225 participants in 3 patient groups
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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