Acute Ischemic Stroke
Conditions
Keywords
Acute ischemic stroke, Large vessel occlusion, Mechanical thrombectomy, Extended time, Randomised clinical trial
Brief summary
A multi-center, prospective, randomized, open-label, adaptive group sequential designed, blinded endpoint assessment (PROBE) clinical trial of endovascular treatment among selected AIS
Detailed description
The LATE-MT trial aims to determine that compared with standard medical care without MT, performing MT in a time window that exceeds 24 hours after last seen well, is superior on the functional outcome in AIS patients due to LVO who have been carefully selected by clinical and imaging criteria. The secondary aims include comparing with standard medical care without MT, to determine whether performing MT exceeding 24 hours of last known well is safe on the risks of any ICH, sICH, and any SAE. Other secondary aims include early improvement in neurological recovery as measured by NIHSS scores at 7 days; successful recanalization rate; imaging measurements of infarct size; death or major disability (mRS 3-6); separately on death and disability (mRS 3-5); HRQoL using Euro-QoL EQ-5D questionnaire; utility-weighted modified Rankin scale scores; duration of hospitalization; Barthel Index; and hospital service costs.
Interventions
PROCEDUREMechanical thrombectomy
Subjects in intervention group will receive MT as soon as possible. Investigators and clinicians should strive to reduce delays of pre-surgery procedure and follow the local standard guideline of MT during the operation and perioperative period. All CFDA approved devices are allowed in this trial. Angioplasty and stent placement can be performed at the discretion of the physicians. Base on site experience, the randomization-operation start period should be within 60 minutes.
Sponsors
Fudan University
Changhai Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age ≥18 years 2. Present 24-72 hours of stroke onset or last seen well 3. Clinical diagnosis of AIS due to anterior circulation LVO (from internal carotid artery (ICA) extracranial segment to middle cerebral artery (MCA) M1 and M2 segment) on brain imaging 4. National Institute of Health stroke scale (NIHSS) ≥6 at randomisation 5. Viable cerebral tissue on computerized tomography perfusion (CTP) assessed: infarct core volume \<50 mL, mismatch ratio ≥1.8, and mismatch volume ≥15 mL 6. Written informed consent (by patient or proxy, according to local requirements)
Exclusion criteria
Clinical
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Functional recovery (level of disability) | at 90 days | A sequence shift (improvement) in scores on the modified Rankin scale (mRS). The value range 0-6: higher scores mean a worse outcome. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Neurological function | at 24 hours and 7 days | Measured by scores on the National Institute of Health Stroke Scale (NIHSS). The value range 0-42: higher scores mean a worse outcome. |
| Death or major disability | at 90 days | mRS 3-6 |
| Major disability | at 90 days | mRS 3-5 |
| Death | within 90 days | Death from any cause |
| Utility-weighted modified Rankin scale scores | at 90 days | Utility-weighted mRS scores calculated by utility weights. A higher score indicates a better outcome |
| Health-related Quality of Life (HRQoL) | at 90 days | Using the EuroQol 5 Dimension 5 Level (EQ 5D 5L) questionnaire. The EQ 5D 5L comprises five dimensions of health: mobility, self care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has five severity levels (no problems, slight problems, moderate problems, severe problems, and extreme problems) |
| Barthel Index | at 90 days | The total score ranges from 0 to 100, with higher scores indicating greater independence in self care |
| Duration of hospitalization | within 90 days | Duration of hospitalization |
| Hospital service costs | within 90 days | Health economic measurement |
| Infarct volume | at 7 days | Measured on follow-up CT/MRI |
| Recanalization | at 48 hours | Assessed by CTA/MRA |
Countries
China
Contacts
CONTACTLili Song, PhD
CONTACTCraig Anderson, PhD
PRINCIPAL_INVESTIGATORCraig Anderson, PhD
The George Institute for Global Health, China
PRINCIPAL_INVESTIGATORJianmin Liu
Changhai Hospital
Outcome results
None listed