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

NCT06677970 | Recruiting Phase 3 DMC

• 1 other identifier: 4-2024-0880
• Study Type: interventional
• Target: 176
• Locations: 1 country
• Sites: 1

Brief Summary

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

Acute Ischemic Stroke

Keywords

Blood pressure; Ischemic stroke; thrombectomy; outcome

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (32)

• Shift analysis of mRS score distribution.

  3 months

• NIHSS score at 24 hours after endovascular treatment.

  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.

  3 months

• Sustained vessel recanalization on CTA/MRA at 24 hours

  Discharge and 1 month

• Proportion of functional independence at 1 month.

  3 months

Study Arms (2)

Conventional BP magnagement group (SBP ≤180 mmHg)

ACTIVE COMPARATOR

Drug: BP lowering drugs (nicardipine, labetalol, urapidil)

Intensive BP raising group (20% increase in SBP, maximum of 160 mmHg )

ACTIVE COMPARATOR

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

Interventions

BP lowering drugs (nicardipine, labetalol, urapidil) DRUG

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

Conventional BP magnagement group (SBP ≤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.

Intensive BP raising group (20% increase in SBP, maximum of 160 mmHg )

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Department of Neurology, Yonsei University College of Medicine

Seoul, Seoul, 120-752, South Korea

RECRUITING

MeSH Terms

Conditions

Ischemic Stroke

Interventions

Nicardipine; Labetalol; urapidil; Phenylephrine

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Dihydropyridines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Salicylamides; Amides; Amines

Central Study Contacts

Hyo Suk Nam, MD,PhD

CONTACT

82-2-2228-1617; hsnam@yuhs.ac

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The mRS scores and adverse events were determined in participants at 1 month and 3 months via telephone or in person by local certified medical staff who were blinded to the treatment allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: a multicenter, randomized, open Lable, blinded end-point clinical trial.

Study Record Dates

• First Submitted: September 23, 2024
• First Posted: November 7, 2024
• Study Start: October 1, 2024
• Primary Completion (Estimated): December 3, 2029
• Study Completion (Estimated): December 3, 2029
• Last Updated: February 13, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: The data will be available until the study was published.

Locations

KR (1)