Teneteplase Reperfusion Therapy in Acute Ischemic Cerebrovascular Events-Ⅳ(TRACE Ⅳ)
- Conditions
- TenecteplaseMinor Ischemic Stroke
- Interventions
- Drug: Control group
- Registration Number
- NCT06414499
- Lead Sponsor
- Beijing Tiantan Hospital
- Brief Summary
The trial is a multicenter, prospective, open-label, blinded-endpoint randomized controlled design. Participants with acute minor ischemic stroke (baseline NIHSS≤5) accompanied with DWI/FLAIR mismatch will be randomized 1:1 to 0.25mg/kg intravenous tenecteplase or standard medical treatment.
- Detailed Description
The study will be a multicenter, prospective, open-label, blinded-endpoint randomized controlled trial (2 arms with 1:1 randomization). Participants with acute minor ischemic stroke (baseline NIHSS≤5) within 12 hours of symptoms onset (symptom onset is defined by the "last seen normal" principle for wake-up stroke) accompanied with measurable neurological deficit and DWI/FLAIR mismatch will be enrolled. The measurable neurological deficit is defined as impairment of language or motor function. Participants will be randomized into 2 groups: Intervention group (rhTNK-tPA): 0.25mg/kg, the maximum dose does not exceed 25mg. Control group: Standard medical care according to the guideline. The primary endpoint is excellent functional outcome (Modified Rankin Scale score, mRS 0-1) at 90-day.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 1394
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Standard medical care Control group Within 12 hours of symptom onset: Control group: Standard medical care according to the guideline (Stroke. 2019;50(12): e344-e418.). Antiplatelet therapy is chosen by researchers-Single/dual antiplatelet therapy can be chosen. rhTNK-tPA rhTNK-tPA Within 12 hours of symptom onset: Intervention group (rhTNK-tPA): 0.25mg/kg, the maximum dose does not exceed 25mg: 1 vial is dissolved in 3ml of sterile water for injection to prepare a medicinal solution with a concentration of 5.33mg/ml. Calculate the total amount of the drug according to the weight of participant, and the maximum dose shall not exceed 25 mg. It is administered as a single bolus intravenous injection, and the injection is completed within 5-10 seconds.
- Primary Outcome Measures
Name Time Method Excellent functional outcome (Modified Rankin Scale score, mRS 0-1) at 90-day (± 7 days). at 90-day (± 7 days) Modified Rankin Scale score, mRS 0-1
- Secondary Outcome Measures
Name Time Method Total mortality at 90-day (± 7 days) at 90-day (± 7 days) Good functional outcome (mRS 0-2) at 90-day (± 7 days) at 90-day (± 7 days) PH2 type intracranial hemorrhage according to the SITS criteria at 90-day (± 7 days) at 90-day (± 7 days) Ordinal distribution of mRS scores at 90-day (± 7 days) at 90-day (± 7 days) Symptomatic intracranial hemorrhage according to the ECASSIII criteria at 90-day (± 7 days) at 90-day (± 7 days) NIHSS 0-1 at 24-hour, 7-day or discharge (analyze which occurs first) or/ neurological improvement (NIHSS decreased≥2 from baseline) at 24-hour, 7-day or discharge (analyze which occurs first) New clinical vascular events (ischemic stroke/ hemorrhagic stroke/ myocardial infarction/vascular death) at 90-day (± 7 days), with each vascular event being independently evaluated. at 90-day (± 7 days) Symptomatic intracranial hemorrhage according to the ECASSIII criteria at 36-hour, 7-day or discharge (analyze which occurs first). at 36-hour, 7-day or discharge (analyze which occurs first) Any intracranial hemorrhage at 90-day (± 7 days) at 90-day (± 7 days) Moderate and severe bleeding events according to the GUSTO criteria at 90-day (± 7 days) at 90-day (± 7 days) Adverse events/Severe adverse events reported by investigators at 90-day (± 7 days) at 90-day (± 7 days)
Trial Locations
- Locations (1)
Beijing Tiantan Hospital
🇨🇳Beijing, Beijing, China