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NCT Number: NCT06677970

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).

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Key information

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Department of Neurology, Yonsei University College of Medicine

Seoul, 120-752, South Korea

Location status: Recruiting

Location contact

Hyo Suk Nam, MD, PhD

CONTACT

[email protected]

+82 02 2228 1617

About this study

  • This is a prospective, randomized, open-label trial with blinded endpoint assessment (PROBE) design.
  • 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).
  • 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.
  • 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.
  • 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.
  • Neurological scores, functional recovery, and QoL assessments will be conducted by independent evaluators who are blinded to treatment allocation.
  • All data will be collected using electronic case report forms (e-CRF), and anonymized imaging data will be sent to the coordinating center.
  • The coordinating center will perform blinded quantification of imaging results.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

<Inclusion Criteria>

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

<Exclusion Criteria>

  • Age <20
  • Patients who failed recanalization of the intracranial artery after endovascular thrombectomy (modified TICI ≤ 2a).
  • Patients with systolic blood pressure ≥ 150 mmHg after successful recanalization.
  • 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.
  • Patients who developed symptomatic intracranial hemorrhage before study enrollment, after successful recanalization.
  • Patients with contraindications to Phenylephrine.
  • Patients with contraindications to antihypertensive medications.
  • Patients with pre-stroke functional disability (modified Rankin Scale, mRS ≥3).
  • Patients with heart failure and reduced cardiac output, with an ejection fraction (EF) <40%.
  • Patients with end-stage renal disease requiring renal replacement therapy, or chronic kidney disease stage 4 with an eGFR <30 mL/min.
  • Patients currently taking monoamine oxidase (MAO) inhibitors.
  • Patients with persistent bradycardia with a heart rate <45 bpm.
  • Pregnant patients.
  • 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.
  • Patients who do not consent to participate in the study.
  • Patients participating in another study that does not allow co-enrollment.
  • Patients whom the investigator deems unsuitable for study participation for any reason.

Treatment and study plan

BP lowering drugs (nicardipine, labetalol, urapidil)

Drug

After successful reperfusion, appropriate antihypertension medication is administered to control systolic blood pressure <180 mmHg.

BP raising drug (phenylephrine) or BP lowering drugs (nicardipine, labetalol, urapidil)

Drug

After successful reperfusion, appropriate BP raising (20% increase in SBP, maximum of 160 from baseline SBP) are administered.

Primary outcomes

  1. Functinal independence

    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).

  2. Symptomatic Intracranial Hemorrhage (sICH)

    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)

  3. Stroke related death

    Time frame: 3 months

    Stroke related death within 3 months

Secondary outcomes

  1. Shift analysis of mRS score distribution.

    Time frame: 3 months

    Distributional analysis of the modified Rankin Scale (mRS) scores to assess overall functional outcome shift between treatment groups.

  2. NIHSS score at 24 hours after endovascular treatment.

    Time frame: 24 hours

    Difference in National Institutes of Health Stroke Scale (NIHSS) scores between at 24 hours post-EVT.

  3. Major Neurological Improvement at 24 hours, defined as either an NIHSS score of 0-1 or an improvement of 8 or more points.

    Time frame: 3 months

    Proportion of patients achieving substantial neurological recovery within 24 hours after EVT.

  4. Sustained vessel recanalization on CTA/MRA at 24 hours

    Time frame: Discharge and 1 month

    Evaluation of angiographic reperfusion status (modified Thrombolysis in Cerebral Infarction [mTICI] grade ≥2b)

  5. Proportion of functional independence at 1 month.

    Time frame: 3 months

    Percentage of patients achieving mRS 0-2 at 1 month.

  6. Differences in Euro-Q5 instrument.

    Time frame: 36 hours to 1 week

    Differences in scores measured by Euro-Q5 scale.

  7. Incidence of malignant cerebral edema.

    Time frame: 36 hours

    Frequency of radiologically or clinically confirmed malignant cerebral edema after EVT.

  8. Infarction volumes

    Time frame: 36 hours

    Proportion of functional independence according to infarction volumes in DWI

  9. Using intravenous BP lowering drug

    Time frame: 3 months

    Proportion of functional independence according to intrvenous BP lowering drug

  10. Medication induced BP drop

    Time frame: 3 months

    Proportion of functional independence according to medication inuced BP drop

  11. Collateral circulation measured by Tan scale (good collateral is defined as Tan scale 2-3) in baseline CTA.

    Time frame: 3 months

    Proportion of functional independence according to the degree of collateral flow

  12. Variability in blood pressure (e.g., standard deviation, coefficient of variation, VIM, successive variation, and threshold).

    Time frame: 3 months

    Evaluation of outcome associations with multiple BP variability indices

  13. Outcome comparison by baseline ischemic core burden measured with ASPECTS.

    Time frame: 3 months

    Proportion of functional independence according to the ASPECTS (Alberta Stroke Program Early CT Score) on CT or MRI.

  14. Evaluation of differential outcomes in patients who received IV tPA before EVT.

    Time frame: 3 months

    Proportion of functional independence according to prior tPA administration.

  15. Comparison of outcomes according to presence or severity of intracranial atherosclerotic stenosis.

    Time frame: 3 months

    Proportion of functional independence according to intracranial arterial stenosis.

  16. Assessment of outcome differences by number of thrombectomy passes.

    Time frame: 3 months

    Proportion of functional independence according to multiple attempts at endovascular recanalization.

  17. Evaluation of outcomes relative to attainment and timing of post-EVT BP target.

    Time frame: 3 months

    Proportion of functional independence according to achieving the target blood pressure and the time to target on outcomes.

  18. Outcome comparison by initial angiographic reperfusion grade before BP intervention.

    Time frame: 3 months

    Proportion of functional independence according to baseline mTICI scores.

  19. Assessment of outcome differences between patients with and without early neurological worsening.

    Time frame: 3 months

    Proportion of functional independence according to neurological deterioration (NIHSS worsening by ≥4 points).

  20. Evaluation of outcomes stratified by occlusion site (e.g., ICA, M1, M2).

    Time frame: 3 months

    Proportion of functional independence according to the occluded vessel involved.

  21. Biochemical markers including D-dimer, CRP, or glucose

    Time frame: 3 months

    Proportion of functional independence according to laboratory findings including D-dimer, CRP, or glucose.

  22. Evaluation of vascular stiffness as a determinant of post-EVT outcomes.

    Time frame: 3 months

    Proportion of functional independence according to estimated pulse wave velocity (ePWV).

  23. Small artery disease - white matter hyperintensity

    Time frame: 3 months

    Proportion of functional independence according to degree of white matter hyperintensity

  24. Small artery disease - microbleeds

    Time frame: 3 months

    Proportion of functional independence according to number of microbleeds

  25. Small artery disease - old lacunar infarction

    Time frame: 3 months

    Proportion of functional independence according to number of old lacunar infarctions

  26. Optimal target BP according to AI predicting for functional independence in 10 mmHg increments

    Time frame: 3 months

    Model-based identification of the optimal SBP target range predicted by AI for favorable outcomes.

  27. Occurrence of adverse event or serious adverse event

    Time frame: 3 months

    Incidence and type of adverse events

  28. Treatment failure, defined as failure to achieve target blood pressure on two consecutive measurements within 24 hours after endovascular therapy.

    Time frame: 24 hours

    Rate of unsuccessful BP target attainment during the acute post-procedure period.

  29. Differences in BP variability depending on the antihypertensive agent use (labetalol or nicardipine).

    Time frame: 24 hours

    Comparison of short-term BP stability between BP medication used for post-EVT management.

  30. Differences in causes of death.

    Time frame: 3 months

    Comparison of mortality causes

  31. Diffrences in fuctional outcomes at 1 year.

    Time frame: 1 year

    Difference in 1-year functional outcomes according to mRS and EQ-5D-5L.

  32. Euro-Q5-5L analogue scale.

    Time frame: 1 year

    Differnec in scores measured by Euro-Q5 scale.

Study contacts

Contact information is provided by the study sponsor or research team.

Hyo Suk Nam, MD,PhD

CONTACT

[email protected]

82-2-2228-1617

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Important dates

Study start
2024
Primary completion
2029
Study completion
2029
First posted
Nov 7, 2024
Registry last updated
Feb 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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