Thrombolysis Treated by TNK-tPA in Acute Ischemic Stroke Patients: a Multi-center, Block Randomized, Positive Drug Parallel Control and Non-inferior Phase Ⅲ Trial, 3T Stroke-Ⅲ
Overview
- Phase
- Phase 3
- Intervention
- Tenecteplase
- Conditions
- Acute Ischemic Stroke
- Sponsor
- Beijing Tiantan Hospital
- Enrollment
- 1630
- Locations
- 63
- Primary Endpoint
- Modified Rankin Scale(mRS)
- Status
- Recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
The trial is prospective, 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 to 0.25mg/kg 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 3 trial (2 arm with 1:1 randomization) in ischemic stroke patients. Imagine is performed with CT or MRI acutely with imaging follow-up at 24-36 hours. The sample size is 1630.
Investigators
Yongjun Wang
President of Beijing Tiantan Hospital, Capital Medical University, Director of Neurology Center
Beijing Tiantan Hospital
Eligibility Criteria
Inclusion Criteria
- •18≤Age≤80 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)
- •Patients planning to receive endovascular therapy
- •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;
Arms & Interventions
Tenecteplase
Patients will receive intravenous Tenecteplase, 0.25mg/kg, maximum 25mg, administered as a bolus over 5\~10 seconds
Intervention: Tenecteplase
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.
Intervention: Alteplase
Outcomes
Primary Outcomes
Modified Rankin Scale(mRS)
Time Frame: 90±7 days
Proportion of subjects with mRS scores of (0-1) at 90±7 days.
Secondary Outcomes
- National Institutes of Health Stroke Scale (NIHSS)(7±2days or discharge)
- Modified Rankin Scale(mRS)(90±7 days)
- The new vascular events(90±7 days)
- EQ-5D(90±7 days)