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Outcome in Patients Treated with Intraarterial thrombectomy - optiMAL Blood Pressure control (OPTIMAL-BP 2)

Outcome in Patients Treated with Intraarterial thrombectomy - optiMAL Blood Pressure control (OPTIMAL-BP 2)

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CRIS
Registry ID
KCT0011595
Enrollment
352
Registered
2026-02-10
Start date
2026-02-28
Completion date
Unknown
Last updated
2026-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Others(Blood pressure control) : After successful arterial recanalization: Intensive Blood Pressure control Group (targeting a 20% increase from baseline systolic BP (SBP), with maximum SBP maintained

Sponsors

Yonsei University Health System, Severance Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria: 1. Patients aged <20 years. 2. Patients in whom intraarterial recanalization has failed (modified TICI =2a). 3. Patients with systolic blood pressure =150 mmHg after successful recanalization. 4. Patients with contraindications to BP-elevating agents after intraarterial thrombectomy, or cases in which the investigator determines that active BP modulation may adversely affect cerebral perfusion or increase the risk of hemorrhage. 5. Patients who develop symptomatic intracranial hemorrhage after successful recanalization but before study participation. 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.

Design outcomes

Primary

MeasureTime frame
Modified Rankin scale scores(mRS) [ Time Frame: 90 days ] Effectiveness outcome: Functional independence (modified Rankin score 0 to 2);ymptomatic intracerebral hemorrhage: Number of participants with symptomatic intracerebral hemorrhage;death [ Time Frame: 90 days ]

Secondary

MeasureTime frame
Shift analysis of mRS score distribution.;NIHSS score at 24 hours after endovascular treatment.;Major Neurological Improvement at 24 hours, defined as either an NIHSS score of 0–1 or an improvement of 8 or more points.;Sustained vessel recanalization on CTA/MRA at 24 hours ;Proportion of functional independence at 1 month.;Differences in Euro-Q5 instrument.; Incidence of malignant cerebral edema.;Infarction volumes;Using intravenous BP lowering drug;Medication induced BP drop;Collateral circulation measured by Tan scale (good collateral is defined as Tan scale 2–3) in baseline CTA.;Variability in blood pressure (e.g., standard deviation, coefficient of variation, VIM, successive variation, and threshold).;Outcome comparison by baseline ischemic core burden measured with ASPECTS.;Evaluation of differential outcomes in patients who received IV tPA before EVT.;Comparison of outcomes according to presence or severity of intracranial atherosclerotic stenosis.;Assessment of outcome differences by number of thrombectomy passes.;Evaluation of outcomes relative to attainment and timing of post-EVT BP target.;Outcome comparison by initial angiographic reperfusion grade before BP intervention.;Assessment of outcome differences between patients with and without early neurological worsening.;Evaluation of outcomes stratified by occlusion site (e.g., ICA, M1, M2).;Biochemical markers including D-dimer, CRP, or glucose;Evaluation of vascular stiffness as a determinant of post-EVT outcomes.;Small artery disease - white matter hyperintensity;Small artery disease - microbleeds;Small artery disease - old lacunar infarction;Optimal target BP according to AI predicting for functional independence;Occurrence of adverse event or serious adverse event;Treatment failure, defined as failure to achieve target blood pressure on two consecutive measurements within 24 hours after endovascular therapy.;Differences in BP variability depending on the antihypertensive agent use (labetalol or nicardi

Countries

Korea, Republic of

Contacts

Public ContactHYE MI Lee

Yonsei University Health System, Severance Hospital

hamstarr@yuhs.ac+82-2-2228-8460

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Mar 14, 2026