Stroke, Acute, Stroke, Ischemic
Conditions
Keywords
Thrombolysis, Endovascular treatment, rhTNK-tPA
Brief summary
The purpose of this trial is to investigate whether intravenous rhTNK-tPA prior to endovascular treatment can improve 90-day functional outcome of stroke patients with large vessel occlusion who are thrombolysis-eligible within 4.5 hours of symptom onset.
Detailed description
The DEVT, SKIP and DIRECT-MT trials showed that endovascular treatment alone is not inferior to intravenous alteplase bridging with endovascular treatment in terms of achieving 90-day functional independence for stroke patients with large vessel occlusion. The EXTEND-IA TNK part 1 and part 2 demonstrated that intravenous thrombolysis with tenecteplase is superior to alteplase before endovascular treatment. However, it is unclear whether intravenous tenecteplase bridging with endovascular treatment is superior to endovascular treatment alone. The purpose of this trial is to investigate whether intravenous rhTNK-tPA bridging with endovascular treatment is better than endovascular treatment alone for stroke patients with large vessel occlusion who are thrombolysis-eligible within 4.5 hours of onset.
Interventions
DRUGrhTNK-tPA
intravenous thrombolysis with rhTNK-tPA followed by endovascular treatment
OTHEREndovascular treatment
endovascular treatment
Sponsors
CSPC RECOMGEN PHARMACEUTICAL (GUANGZHOU) CO.,LTD
Xinqiao Hospital of Chongqing
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. Aged 18 years or older; 2. Patient with acute ischemic stroke who is eligible for intravenous thrombolysis treatment within 4.5 hours of time last known well; 3. No significant prestroke functional disability: for age \<80 years, prestroke modified Rankin scale (mRS) ≤2; for age ≥80 years, prestroke mRS ≤1; 4. MCA-M1 or -M2, basilar artery, or posterior cerebral artery-P1 occlusion proved by CTA/MRA; 5. EVT is planned by clinical care team; 6. Written informed consent is obtained from patients and/or their legal representatives.
Exclusion criteria
1. Intracranial hemorrhage on baseline CT or MR 2. Contraindication to intravenous thrombolytics 3. Already received intravenous thrombolytic after index stroke 4. Known pregnancy, or breastfeeding, or serum beta human chorionic gonadotropin test is positive on admission 5. Contraindication to radiographic contrast agents, nickel, titanium metals or their alloys 6. Current participation in another investigational drug clinical trial 7. Arterial tortuosity and/or other arterial disease that would lead to unstable access platform or prevent the thrombectomy device from reaching the target vessel 8. Patient with a preexisting neurological or psychiatric disease that would confound the outcome assessments 9. Patient with occlusions in two or more vascular territories (e.g. bilateral territories, or anterior and posterior circulation) 10. Mass effect or intracranial neoplasm on baseline CT or MR (except small meningioma) 11. Intracranial arteriovenous malformation or aneurysm on baseline CT or MR angiography 12. Any terminal disease with a life expectancy less than half a year 13. Unlikely to be available for follow-up at 90 days.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of patients functionally independent (mRS score 0 to 2) at 90 days | 90 days | functional independence |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Successful reperfusion at end-of-procedure angiography | 15 minutes after initial angiogram | evaluate vascular patency after thrombectomy |
| First-pass reperfusion | After artery puncture, but before thrombectomy | defined as Expanded Treatment in Cerebral Infarction ≥2c after the first thrombectomy pass |
| Modified first-pass reperfusion | After artery puncture, but before thrombectomy | defined as Expanded Treatment in Cerebral Infarction ≥2b after the first thrombectomy pass |
| National Institutes of Health Stroke Scale (NIHSS) score | 5 to 7 days or discharge | Neurological status |
| modified Rankin scale score | 90 days | disability level |
| Proportion of patients non-disabled (mRS score 0 to 1) or return to pre-morbid mRS score at 90 days (for patients with mRS > 1) | 90 days | excellent outcome |
| Substantial reperfusion at initial angiogram | within 5 minutes at initial angiogram | evaluate effect of tenecteplase on reperfusion |
| Health-related quality of life, assessed with the European Quality Five Dimensions Five Level scale (EQ-5D-5L) | 90 days | Health-related quality of life |
| Any radiologic intracranial hemorrhage within 48 hours | within 48 hours after endovascular treatment | evaluate intracranial hemorrhage |
| Symptomatic intracranial hemorrhage within 48 hours | within 48 hours after endovascular treatment | evaluate intracranial hemorrhage (Heidelberg classification) |
| Mortality within 90 days | 90 days | evaluate death rate of the two treatment groups |
| Procedural-related complications | within 90 days | evaluate complications |
| Severe adverse events | within 90 days | evaluate any adverse events |
| Proportion of patients ambulatory or bodily needs-capable or better (mRS score 0 to 3) | 90 days | ambulatory or bodily needs-capable or better |
Countries
China
Outcome results
None listed