Table 5 Trial design of the randomized comparative phase of T-FLAVOR
From: Development of tenecteplase for stroke thrombolysis: Japan’s endeavor
Item | Details |
|---|---|
Number of Participants | 220 |
Target disease | Acute Ischemic Stroke |
Study Type | Interventional |
Study Design | Randomized, Two-arm, Open-label, Controlled |
Main Inclusion Criteria | - Acute ischemic stroke - Age ≥ 20 years (no upper age limit) - Both sexes eligible- Eligible to receive intravenous thrombolysis based on recommendations of Japanese alteplase guideline - Eligible to commence intravenous thrombolysis within 4.5 h of onset - Occlusion of the internal carotid artery, middle cerebral artery (M1 or M2), or basilar artery confirmed by CT angiography or MR angiography - Eligible to commence mechanical thrombectomy (arterial puncture) within 6 h of onset - Written informed consent obtained from the patient or legal representative |
Main Exclusion Criteria | - Pre-stroke disability (modified Rankin Scale ≥ 4) - More than 4.5 h since stroke onset or last known well time - Known allergy to contrast media - Terminal illness with expected life expectancy less than 1 year - Pregnant, breast-feeding, or of child-bearing potential - Currently participating in or planning to participate in another clinical trial during the study period - Judged as inappropriate for this study by the principal or sub-investigator |
Intervention | Intravenous administration of tenecteplase (0.25 mg/kg) or alteplase (0.6 mg/kg), allocated 1:1 |
Primary Efficacy Endpoint | Substantial angiographic recanalization (mTICI 2b/2c/3) or absence of retrievable thrombus on the initial angiogram |
Primary Safety Endpoints | - Symptomatic intracranial hemorrhage within 24–36 h after administration - All-cause mortality at 90 days |
Secondary Endpoints | - ≥8 points reduction in the NIH Stroke Scale score or reaching 0–1 at 72 h after thrombolysis - Shift analysis of modified Rankin Scale (mRS) at 90 days - mRS 0–1 or unchanged from pre-stroke mRS at 90 days - mRS 0–2 or unchanged from pre-stroke mRS at 90 days |
Discontinuation Criteria | - Occurrence of an adverse event requiring discontinuation as judged by the investigator - Withdrawal of consent by the participant - Serious bleeding complications making continuation difficult - Use of prohibited concomitant medications or therapies - Determined to be inappropriate as a study participant - Inability to conduct required assessments or examinations due to participant circumstances - Other reasons deemed appropriate for discontinuation by the investigator |
