Department of Neurology, Yonsei University College of Medicine
Seoul, 120-752, South Korea
Location status: Recruiting
NCT Number: NCT06677970
Though intravenous thrombolysis has been shown to improve symptoms in acute ischemic stroke patients, the recanalization rate remains low (22.6%) and only around 30% of patients benefit from the treatment. Recently, endovascular thrombectomy using stent retrievers or catheters has proven to be more effective, with a success rate of nearly 80%. However, only 50% of patients experience clinical improvement, highlighting the need for new treatment strategies to enhance outcomes. Current guidelines recommend maintaining systolic blood pressure (BP) below 180 mmHg after thrombectomy, but there is a lack of evidence regarding optimal blood pressure management post-reperfusion.
Four randomized clinical trials, including the OPTIMAL-BP trial, have examined blood pressure control following thrombectomy. Meta-analyses showed that intensive BP lowering did not reduce symptomatic hemorrhage and was associated with worse functional outcomes at 3 months. Specifically, lowering BP too aggressively after successful reperfusion could worsen outcomes by reducing perfusion to the ischemic penumbra. Therefore, this study will investigate whether a more targeted blood pressure elevation strategy could improve patient prognosis compared to standard BP control in patients with sustained systolic blood pressure (SBP) <150 mmHg on successive measurements obtained less than 10 minutes apart within 3 hours after reperfusion.
This is a prospective, randomized, open-label trial with blinded endpoint assessment (PROBE) design, aimed at comparing intensive and standard BP control strategies in acute ischemic stroke patients. Participants will be randomized 1:1 into either an intensive BP control group (targeting a 20% systolic BP increase, capped at less than 160 mmHg) or a standard BP control group (systolic BP at or below 180 mmHg).
Interested in participating?
Request Info20 year and older
All sexes
Interventional
Phase 3
Seoul, 120-752, South Korea
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
<Inclusion Criteria>
<Exclusion Criteria>
After successful reperfusion, appropriate antihypertension medication is administered to control systolic blood pressure <180 mmHg.
After successful reperfusion, appropriate BP raising (20% increase in SBP, maximum of 160 from baseline SBP) are administered.
Time frame: 3 months
Proportion of patients with a functional independence (defined as mRS ≤ 2) at 3 months, assessed using the modified Rankin Scale (mRS).
Time frame: 36 hours
Symptomatic Intracranial Hemorrhage (sICH) after Endovascular Treatment Intracranial hemorrhage or hemorrhagic transformation identified on MRI (GRE or SWI) or CT within 24 ± 12 hours or due to clinical worsening.
(Symptomatic intracranial hemorrhage is defined according to the European Cooperative Acute Stroke Study III [ECASS III] criteria)
Time frame: 3 months
Stroke related death within 3 months
Time frame: 3 months
Distributional analysis of the modified Rankin Scale (mRS) scores to assess overall functional outcome shift between treatment groups.
Time frame: 24 hours
Difference in National Institutes of Health Stroke Scale (NIHSS) scores between at 24 hours post-EVT.
Time frame: 3 months
Proportion of patients achieving substantial neurological recovery within 24 hours after EVT.
Time frame: Discharge and 1 month
Evaluation of angiographic reperfusion status (modified Thrombolysis in Cerebral Infarction [mTICI] grade ≥2b)
Time frame: 3 months
Percentage of patients achieving mRS 0-2 at 1 month.
Time frame: 36 hours to 1 week
Differences in scores measured by Euro-Q5 scale.
Time frame: 36 hours
Frequency of radiologically or clinically confirmed malignant cerebral edema after EVT.
Time frame: 36 hours
Proportion of functional independence according to infarction volumes in DWI
Time frame: 3 months
Proportion of functional independence according to intrvenous BP lowering drug
Time frame: 3 months
Proportion of functional independence according to medication inuced BP drop
Time frame: 3 months
Proportion of functional independence according to the degree of collateral flow
Time frame: 3 months
Evaluation of outcome associations with multiple BP variability indices
Time frame: 3 months
Proportion of functional independence according to the ASPECTS (Alberta Stroke Program Early CT Score) on CT or MRI.
Time frame: 3 months
Proportion of functional independence according to prior tPA administration.
Time frame: 3 months
Proportion of functional independence according to intracranial arterial stenosis.
Time frame: 3 months
Proportion of functional independence according to multiple attempts at endovascular recanalization.
Time frame: 3 months
Proportion of functional independence according to achieving the target blood pressure and the time to target on outcomes.
Time frame: 3 months
Proportion of functional independence according to baseline mTICI scores.
Time frame: 3 months
Proportion of functional independence according to neurological deterioration (NIHSS worsening by ≥4 points).
Time frame: 3 months
Proportion of functional independence according to the occluded vessel involved.
Time frame: 3 months
Proportion of functional independence according to laboratory findings including D-dimer, CRP, or glucose.
Time frame: 3 months
Proportion of functional independence according to estimated pulse wave velocity (ePWV).
Time frame: 3 months
Proportion of functional independence according to degree of white matter hyperintensity
Time frame: 3 months
Proportion of functional independence according to number of microbleeds
Time frame: 3 months
Proportion of functional independence according to number of old lacunar infarctions
Time frame: 3 months
Model-based identification of the optimal SBP target range predicted by AI for favorable outcomes.
Time frame: 3 months
Incidence and type of adverse events
Time frame: 24 hours
Rate of unsuccessful BP target attainment during the acute post-procedure period.
Time frame: 24 hours
Comparison of short-term BP stability between BP medication used for post-EVT management.
Time frame: 3 months
Comparison of mortality causes
Time frame: 1 year
Difference in 1-year functional outcomes according to mRS and EQ-5D-5L.
Time frame: 1 year
Differnec in scores measured by Euro-Q5 scale.
Contact information is provided by the study sponsor or research team.
Yonsei University
Other
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