A Phase 3 interventional study of Intravenous thrombolysis agents and endovascular thrombectomy in Stroke, Acute Ischemic, sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-02-14.
Sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University · Phase 3, Interventional, and Treatment
The primary hypothesis being tested in this trial is that ischemic stroke patients in large vessel occlusion of anterior circulation at 4.5 - 9 hours post onset of stroke will have improved clinical outcomes when given endovascular thrombectomy with intravenous thrombolysis compared with that of given direct endovascular thrombectomy alone.
A number of multicenter randomized controlled trials have provided evidence supporting the application of endovascular therapy for acute ischemic stroke with anterior circulation large vessel occlusion. However, whether intravenous thrombolysis is necessary before endovascular therapy is still controversial. The combined trial data (including DEVT, DIRECT-MT, MR-CLEAN NO-IV and SKIP) assessing direct mechanical thrombectomy versus bridging therapy showed no difference in improving good functional outcome. However, a recent observational cohort study of 15832 patients treated with EVT, intravenous alteplase treatment was associated with better in-hospital survival and functional outcomes after adjusting for other covariates.
The 2019 AHA/ASA guidelines for the early management of patients with ischemic stroke states that mechanical thrombectomy is recommended for patients with anterior circulation large vessel occlusion within 6-24 hours of last known normal who meet the DWAN or DEFUSE-3 criteria (level I recommendation, level A evidence). The DEFUSE 3 perfusion-infarction core mismatch criteria is: core infarct volume \<70mL, ischemic penumbra volume >15mL, and hypoperfusion volume/core infarct volume >1.8. Intravenous thrombolytic therapy is recommended for patients with ischemic stroke within 4.5 hours of onset. A meta-analysis of three randomized controlled trials recently published in the Lancet found that ischemic stroke at 4.5 to 9 hours of onset or wake stroke was consistent with a core infarct volume \<70mL, a penumbra volume >10mL, and a hypoperfusion volume/core infarct volume >1.2. Benefit from intravenous thrombolytic therapy (3 month mRS 0-1 ratio, thrombolytic vs non-thrombolytic: 36% vs 29%). It was also strongly recommended by 2021 ESO guidelines on intravenous thrombolysis for acute ischemic stroke.
For these reasons the investigators hypothesize that endovacular thrombectomy bridging with intravenous thrombolysis is superior to direct thrombectomy in patients of stroke at 4.5 to 9 hours, guided with perfusion imaging.
7,286 studies on the registry are indexed under Stroke; 2,007 are open to participants now.
This study's planned enrollment of 222 is above the median of 50 across 5,369 interventional studies indexed under Stroke.
Browse Stroke studies →Second Affiliated Hospital, School of Medicine, Zhejiang University is the lead sponsor of 1,058 studies on the registry; 511 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: Intravenous thrombolysis agents · Procedure: endovascular thrombectomy
Procedure: endovascular thrombectomy
Intravenous thrombolysis with recombinant tissue-type plasminogen activator (rt-PA,alteplase) or TNK-tPA (Tenecteplase,Metalyse)
endovascular mechanical thrombectomy with nonspecific device
Good clinical outcome
Score in modified Rankin Scale (mRS) ≤ 2 (mRS is short for modified ranking score, with minimum value of 0 and maximum value of 6. Higher score means a worse outcome.)
Time frame: 90 days after randomization
Mortality
Mortality due to any cause
Time frame: 90 days after randomization
Modified Rankin Scale (mRS) shift analysis
(mRS is short for National Institute of health stroke scale, with minimum value of 0 and maximum value of 6. Higher score means a worse outcome.)
Time frame: day 0 and 90 days after randomization
National Institute of Health Score Scale (NIHSS)
(NIHSS is short for modified ranking score, with minimum value of 0 and maximum value of 42. Higher score means a worse outcome.)
Time frame: day 0 and day 1 after randomization
Thrombolysis in Cerebral Infarction (TICI) scale
TICI is for "Thrombolysis in cerebral Infarction", with minimum value of 0 and maximum value of 3. Higher score means a better reperfusion state.
Time frame: day 0 and day 1 after randomization
Serious adverse events
Leading to death or prolonged hospitalisation
Time frame: day 0 until 90 days after randomization
Intracranial hemorrhage
Hemorrhagic finding on CT or MRI
Time frame: day 1 after randomization
Quality of life assessed by questionnaire
Include but not limited to the Barthelindex of ADL, which is the abbreviation of " activities of daily living", with minimum value of 0 and maximum value of 100. Higher score means a worse outcome.
Time frame: 90 days after randomization
Overall costs incurred during hospitalisation
include charges and expenses of every description
Time frame: 90 days after randomization
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Second Affiliated Hospital, School of Medicine, Zhejiang University