Stroke
Conditions
Keywords
stroke, endovascular thrombectomy, blood pressure, randomised controlled trial
Brief summary
This clinical trial aims to investigate the safety and efficacy of intensive blood pressure lowering after successful reperfusion with thrombectomy in patients with acute anterior circulation large artery occlusive stroke. The main questions it aims to answer are: What is the optimal blood pressure range after revascularization with thrombectomy in patients with cerebral embolism? Can intensive blood pressure lowering improve outcomes in cerebral embolism patients following thrombectomy? Participants will be randomly assigned to either the intervention group, which receives stricter blood pressure control (systolic blood pressure target \<120 mmHg), or the control group, which follows a conventional blood pressure management approach (systolic blood pressure target 140-180 mmHg). Outcomes will be assessed during a 3-month follow-up period.
Interventions
OTHERIntensive blood pressure management
The objective is to achieve a systolic blood pressure (SBP) \<120 mmHg within 1 hour after randomization and maintain this target for 48 hours. Intravenous titration is initiated immediately after randomization, with an SBP of 100 mmHg used as the threshold for discontinuing antihypertensive therapy or initiating vasopressors.
OTHERConventional blood pressure management
The objective is to maintain an SBP of 140-180 mmHg within 1 hour after randomization and sustain this range for 48 hours. Intravenous antihypertensive agents are administered when SBP exceeds 180 mmHg and discontinued once SBP is ≤150 mmHg.
Sponsors
Hao Yonggang
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥ 18 years * To receive endovascular thrombectomy \<24 hours after the onset of symptoms * Diagnosed with acute anterior circulation ischemic stroke * National Institutes of Health Stroke Scale (NIHSS) score ≤ 30; * Alberta Stroke Program Early CT Score (ASPECTS) ≥ 6 * Computed Tomography Angiography (CTA), Magnetic Resonance Angiography (MRA), or Digital Subtraction Angiography (DSA) confirming occlusion of the intracranial internal carotid artery or M1/M2 segment of the middle cerebral artery * Successful recanalization of the occluded vessel without in-situ or proximal stenosis (modified Treatment in Cerebral Infarction, mTICI ≥ 2b) * Sustained elevated systolic blood pressure (≥140 mmHg for at least two consecutive measurements, separated by \>10 minutes) within 3 hours of reperfusion * Written informed consent provided by the patient or their legal representative
Exclusion criteria
* Pre-existing stroke disability defined by a modified Rankin score (mRS) \>2 * Unlikely to benefit from or tolerate endovascular thrombectomy, such as severe allergic reaction to contrast agents * Failure to achieve mTICI ≥ 2b with endovascular intervention, or presence of in situ or proximal vascular stenosis * Patients with contraindications for the use of antihypertensive medications, such as allergy to components * Intracranial space-occupying lesions, including brain tumors and vascular malformations * Patients with severe liver or renal dysfunction, or those receiving dialysis (severe liver dysfunction is defined as alanine aminotransferase \[ALT\] \> 3 times the upper limit of normal or aspartate aminotransferase \[AST\] \> 3 times the upper limit of normal; severe renal dysfunction is defined as serum creatinine \> 3.0 mg/dL \[265.2 μmol/L\] or glomerular filtration rate \[GFR\] \< 30 mL/min/1.73 m²) * Serious illness with life expectancy of \<6 months * Lactating women * Participation in other interventional clinical trials within the past 3 months; * Any other conditions that render patients unsuitable for participation in this study or unable to complete the study process, such as psychiatric disorders, cognitive or emotional impairments, or physical conditions that hinder compliance with study procedures and follow-up
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| All-cause mortality | At 90 days after randomization | — |
| Functional independence at 3 months | At 90 days after randomization | A modified Rankin Scale (mRS) score of 0 to 2 |
| Symptomatic intracerebral hemorrhage | At 24±12 hours after randomization | Defined by the Heidelberg Bleeding Classification criteria |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Extracranial hemorrhage | An 7 days after randomization | Examples include gastrointestinal bleeding, urinary tract bleeding, oral or nasal mucosal bleeding, and subcutaneous hematoma. |
| Excellent outcome | At 90 days after randomization | A modified Rankin Scale (mRS) score of 0 to 1 |
| Serious adverse outcome | At 90 days after randomization | A modified Rankin Scale (mRS) score of 5 to 6 |
| Shift in scores on the mRS | At 90 days after randomization | — |
| Infarct volume at follow-up CT scan (24±12h) | At 24±12 hours after randomization | — |
| NIHSS score at 24 hours | At 24 hours after randomization | — |
| Change in National Institute of Health Stroke Scale (NIHSS) at 24 hours | At 24 hours after randomization | — |
| Excellent recovery of NIHSS score at 24 hours | At 24 hours after randomization | NIHSS 0-1 or improvement of more than 8 |
| Change in National Institute of Health Stroke Scale (NIHSS) at 7 days | At 7 days after randomization | — |
| Edema volume assessed by CT | At 7 days after randomization | — |
| Health-related quality of life (EQ-5D-3L index score) | At 90 days after randomization | Health-related quality of life assessed using the EuroQol EQ-5D-3L descriptive system, converted to an index score using \[country\]-specific value set. |
| Health-related quality of life (EQ-5D VAS) | At 90 days after randomization | Self-rated health status assessed using the EuroQol visual analog scale (EQ-VAS), ranging from 0 (worst imaginable health) to 100 (best imaginable health). |
| Non-hemorrhagic serious adverse events | At 7 days after randomization | — |
| Asymptomatic ICH | At 24±12 hours after randomization | — |
| Large cerebral infarction or intracranial hemorrhage requiring neurosurgical intervention | At 7 days after randomization | — |
Countries
China
Outcome results
None listed