Outcome in Patients Treated With Endovascular Thrombectomy - optIMAL Blood Pressure Control 2 (OPTIMAL-BP 2)

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).

Study Overview

• Status: Recruiting
• Conditions: Acute Ischemic Stroke
• Intervention / Treatment: Drug: BP lowering drugs (nicardipine, labetalol, urapidil); Drug: BP raising drug (phenylephrine) or BP lowering drugs (nicardipine, labetalol, urapidil)

Detailed Description

1. This is a prospective, randomized, open-label trial with blinded endpoint assessment (PROBE) design.
2. Participants will be randomly assigned in a 1:1 ratio to either an intensive BP control group (targeting a 20% increase from baseline systolic BP, capped at less than 160 mmHg) or a standard BP control group (maintaining systolic BP at or below 180 mmHg).
3. Randomization: Allocation will be stratified by stroke severity (NIHSS <15 or ≥15) and participating study center. Randomization will be conducted via a web-based system using a pre-generated randomization table created by a statistician. Investigators will enter stratification variables (study center, NIHSS score) into the system to receive the randomized allocation.
4. This is a multi-center prospective study involving patients admitted to participating hospitals for acute ischemic stroke between October 2024 and December 2029 (last visit date). The study will include patients who undergo successful intra-arterial reperfusion therapy based on current stroke guidelines.
5. Data collection will include the medical history, imaging findings, BP parameters (systolic BP, diastolic BP, BP variability), neurological scores, functional recovery, and quality of life (QoL) measures for eligible participants.
6. Neurological scores, functional recovery, and QoL assessments will be conducted by independent evaluators who are blinded to treatment allocation.
7. All data will be collected using electronic case report forms (e-CRF), and anonymized imaging data will be sent to the coordinating center.
8. The coordinating center will perform blinded quantification of imaging results.

• Study Type: Interventional
• Enrollment (Estimated): 176
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Hyo Suk Nam, MD,PhD; Phone Number: 82-2-2228-1617; Email: hsnam@yuhs.ac

Study Locations

• South Korea
  • Seoul
    • Seoul, Seoul, South Korea, 120-752
      • Recruiting
      • Department of Neurology, Yonsei University College of Medicine
      • Contact: Hyo Suk Nam, MD, PhD; Phone Number: +82 02 2228 1617; Email: hsnam@yuhs.ac

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

<Inclusion Criteria>

1. Age ≥20 years
2. Acute ischemic stroke patients who underwent intraarterial thrombectomy for large vessel occlusion. (ICA, M1, M2, A1, P1, VA and BA)
3. Patients with successful recanalization after intraarterial thrombectomy (TICI 2b or TICI 3)
4. Patients with sustained systolic blood pressure (SBP) <150 mm Hg on successive measurements obtained less than 10 minutes apart within 3 hours after reperfusion.
5. Patients with mean SBP <150 mmHg within 2 hours after successful recanalization (two measurements ≥2 minutes apart).

<Exclusion Criteria>

1. Age <20
2. Patients who failed recanalization of the intracranial artery after endovascular thrombectomy (modified TICI ≤ 2a).
3. Patients with systolic blood pressure ≥ 150 mmHg after successful recanalization.
4. Patients unable to receive antihypertensive medication post-thrombectomy or in whom the investigator believes aggressive blood pressure control could have adverse effects, such as increased risk of hemorrhage.
5. Patients who developed symptomatic intracranial hemorrhage before study enrollment, after successful recanalization.
6. Patients with contraindications to Phenylephrine.
7. Patients with contraindications to antihypertensive medications.
8. Patients with pre-stroke functional disability (modified Rankin Scale, mRS ≥3).
9. Patients with heart failure and reduced cardiac output, with an ejection fraction (EF) <40%.
10. Patients with end-stage renal disease requiring renal replacement therapy, or chronic kidney disease stage 4 with an eGFR <30 mL/min.
11. Patients currently taking monoamine oxidase (MAO) inhibitors.
12. Patients with persistent bradycardia with a heart rate <45 bpm.
13. Pregnant patients.
14. Patients with severe medical or surgical comorbidities, including but not limited to: terminal cancer with life expectancy <6 months, severe cardiac or aortic disease, severe hematologic disorders, advanced chronic heart failure, severe pneumonia, or sepsis.
15. Patients who do not consent to participate in the study.
16. Patients participating in another study that does not allow co-enrollment.
17. Patients whom the investigator deems unsuitable for study participation for any reason.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Conventional BP magnagement group (SBP ≤180 mmHg)	Drug: BP lowering drugs (nicardipine, labetalol, urapidil); After successful reperfusion, appropriate antihypertension medication is administered to control systolic blood pressure <180 mmHg.
Active Comparator: Intensive BP raising group (20% increase in SBP, maximum of 160 mmHg )	Drug: BP raising drug (phenylephrine) or BP lowering drugs (nicardipine, labetalol, urapidil); After successful reperfusion, appropriate BP raising (20% increase in SBP, maximum of 160 from baseline SBP) are administered.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functinal independence	Proportion of patients with a functional independence (defined as mRS ≤ 2) at 3 months, assessed using the modified Rankin Scale (mRS).	3 months
Symptomatic Intracranial Hemorrhage (sICH)	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)	36 hours
Stroke related death	Stroke related death within 3 months	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Shift analysis of mRS score distribution.	Distributional analysis of the modified Rankin Scale (mRS) scores to assess overall functional outcome shift between treatment groups.	3 months
NIHSS score at 24 hours after endovascular treatment.	Difference in National Institutes of Health Stroke Scale (NIHSS) scores between at 24 hours post-EVT.	24 hours
Major Neurological Improvement at 24 hours, defined as either an NIHSS score of 0-1 or an improvement of 8 or more points.	Proportion of patients achieving substantial neurological recovery within 24 hours after EVT.	3 months
Sustained vessel recanalization on CTA/MRA at 24 hours	Evaluation of angiographic reperfusion status (modified Thrombolysis in Cerebral Infarction [mTICI] grade ≥2b)	Discharge and 1 month
Proportion of functional independence at 1 month.	Percentage of patients achieving mRS 0-2 at 1 month.	3 months
Differences in Euro-Q5 instrument.	Differences in scores measured by Euro-Q5 scale.	36 hours to 1 week
Incidence of malignant cerebral edema.	Frequency of radiologically or clinically confirmed malignant cerebral edema after EVT.	36 hours
Infarction volumes	Proportion of functional independence according to infarction volumes in DWI	36 hours
Using intravenous BP lowering drug	Proportion of functional independence according to intrvenous BP lowering drug	3 months
Medication induced BP drop	Proportion of functional independence according to medication inuced BP drop	3 months
Collateral circulation measured by Tan scale (good collateral is defined as Tan scale 2-3) in baseline CTA.	Proportion of functional independence according to the degree of collateral flow	3 months
Variability in blood pressure (e.g., standard deviation, coefficient of variation, VIM, successive variation, and threshold).	Evaluation of outcome associations with multiple BP variability indices	3 months
Outcome comparison by baseline ischemic core burden measured with ASPECTS.	Proportion of functional independence according to the ASPECTS (Alberta Stroke Program Early CT Score) on CT or MRI.	3 months
Evaluation of differential outcomes in patients who received IV tPA before EVT.	Proportion of functional independence according to prior tPA administration.	3 months
Comparison of outcomes according to presence or severity of intracranial atherosclerotic stenosis.	Proportion of functional independence according to intracranial arterial stenosis.	3 months
Assessment of outcome differences by number of thrombectomy passes.	Proportion of functional independence according to multiple attempts at endovascular recanalization.	3 months
Evaluation of outcomes relative to attainment and timing of post-EVT BP target.	Proportion of functional independence according to achieving the target blood pressure and the time to target on outcomes.	3 months
Outcome comparison by initial angiographic reperfusion grade before BP intervention.	Proportion of functional independence according to baseline mTICI scores.	3 months
Assessment of outcome differences between patients with and without early neurological worsening.	Proportion of functional independence according to neurological deterioration (NIHSS worsening by ≥4 points).	3 months
Evaluation of outcomes stratified by occlusion site (e.g., ICA, M1, M2).	Proportion of functional independence according to the occluded vessel involved.	3 months
Biochemical markers including D-dimer, CRP, or glucose	Proportion of functional independence according to laboratory findings including D-dimer, CRP, or glucose.	3 months
Evaluation of vascular stiffness as a determinant of post-EVT outcomes.	Proportion of functional independence according to estimated pulse wave velocity (ePWV).	3 months
Small artery disease - white matter hyperintensity	Proportion of functional independence according to degree of white matter hyperintensity	3 months
Small artery disease - microbleeds	Proportion of functional independence according to number of microbleeds	3 months
Small artery disease - old lacunar infarction	Proportion of functional independence according to number of old lacunar infarctions	3 months
Optimal target BP according to AI predicting for functional independence in 10 mmHg increments	Model-based identification of the optimal SBP target range predicted by AI for favorable outcomes.	3 months
Occurrence of adverse event or serious adverse event	Incidence and type of adverse events	3 months
Treatment failure, defined as failure to achieve target blood pressure on two consecutive measurements within 24 hours after endovascular therapy.	Rate of unsuccessful BP target attainment during the acute post-procedure period.	24 hours
Differences in BP variability depending on the antihypertensive agent use (labetalol or nicardipine).	Comparison of short-term BP stability between BP medication used for post-EVT management.	24 hours
Differences in causes of death.	Comparison of mortality causes	3 months
Diffrences in fuctional outcomes at 1 year.	Difference in 1-year functional outcomes according to mRS and EQ-5D-5L.	1 year
Euro-Q5-5L analogue scale.	Differnec in scores measured by Euro-Q5 scale.	1 year

Collaborators and Investigators

• Sponsor: Yonsei University

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2024
• Primary Completion (Estimated): December 3, 2029
• Study Completion (Estimated): December 3, 2029

Study Registration Dates

• First Submitted: September 23, 2024
• First Submitted That Met QC Criteria: November 6, 2024
• First Posted (Actual): November 7, 2024

Study Record Updates

• Last Update Posted (Actual): February 13, 2026
• Last Update Submitted That Met QC Criteria: February 10, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: outcome; Blood pressure; Ischemic stroke; thrombectomy
• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Stroke; Ischemic Stroke; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Amides; Amines; Alcohols; Amino Alcohols; Ethanolamines; Dihydropyridines; Salicylamides; Phenylephrine; Labetalol; Nicardipine; urapidil
• Other Study ID Numbers: 4-2024-0880

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: After study competition, the participating researcher can submitt the proposal. Publication committee will evaluate the proposal and approve it. After approval, patients data will be shared with researcher.
• IPD Sharing Time Frame: The data will be available until the study was published.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No