Actively Recruiting
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
Eligibility Criteria
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)
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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Department of Neurology, Yonsei University College of Medicine
Seoul, Seoul, South Korea, 120-752
Actively Recruiting
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
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here