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RECRUITING

NCT06677970

PHASE3

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

Sponsor: Yonsei University

View on ClinicalTrials.gov

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).

Key Details

Gender

All

Age Range

20 Years - Any

Study Type

INTERVENTIONAL

Enrollment

176

Start Date

2024-10-01

Completion Date

2029-12-03

Last Updated

2026-02-13

Healthy Volunteers

Conditions

Acute Ischemic Stroke

Interventions

DRUG

BP lowering drugs (nicardipine, labetalol, urapidil)

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

DRUG

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

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

\<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\> 1. Age \<20 2. Patients who failed recanalization of the intracranial artery after endovascular thrombectomy (modified TICI ≤ 2a). 3. Patients with systolic blood pressure ≥ 150 mmHg after successful recanalization. 4. 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. 5. Patients who developed symptomatic intracranial hemorrhage before study enrollment, after successful recanalization. 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.

Locations (1)

Department of Neurology, Yonsei University College of Medicine

Seoul, Seoul, South Korea