Actively Recruiting

Phase 3
Age: 20Years +
All Genders
NCT06677970

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

Led by Yonsei University · Updated on 2026-02-13

176

Participants Needed

1

Research Sites

269 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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).

CONDITIONS

Official Title

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

Who Can Participate

Age: 20Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 20 years or older
  • Acute ischemic stroke patients who underwent intraarterial thrombectomy for large vessel occlusion (ICA, M1, M2, A1, P1, VA, BA)
  • Successful recanalization after intraarterial thrombectomy (TICI 2b or TICI 3)
  • Sustained systolic blood pressure less than 150 mm Hg on successive measurements obtained less than 10 minutes apart within 3 hours after reperfusion
  • Mean systolic blood pressure less than 150 mmHg within 2 hours after successful recanalization (two measurements at least 2 minutes apart)
Not Eligible

You will not qualify if you...

  • Age younger than 20 years
  • Failed recanalization of the intracranial artery after endovascular thrombectomy (modified TICI 2a or less)
  • Systolic blood pressure 150 mmHg or higher after successful recanalization
  • Unable to receive antihypertensive medication post-thrombectomy or at risk of adverse effects from aggressive blood pressure control
  • Symptomatic intracranial hemorrhage before study enrollment after successful recanalization
  • Contraindications to Phenylephrine
  • Contraindications to antihypertensive medications
  • Pre-stroke functional disability with modified Rankin Scale score 3 or higher
  • Heart failure with ejection fraction less than 40%
  • End-stage renal disease requiring renal replacement therapy or chronic kidney disease stage 4 with eGFR less than 30 mL/min
  • Current use of monoamine oxidase inhibitors
  • Persistent bradycardia with heart rate less than 45 bpm
  • Pregnancy
  • Severe medical or surgical comorbidities including terminal cancer with life expectancy less than 6 months, severe cardiac or aortic disease, severe hematologic disorders, advanced chronic heart failure, severe pneumonia, or sepsis
  • Lack of consent to participate
  • Participation in another study that disallows co-enrollment
  • Investigator deems unsuitable for participation for any reason

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Trial Site Locations

Total: 1 location

1

Department of Neurology, Yonsei University College of Medicine

Seoul, Seoul, South Korea, 120-752

Actively Recruiting

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Research Team

H

Hyo Suk Nam, MD,PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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