NCT06677970

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

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 176 (estimated)
• Sponsor: Yonsei University · Academic / Other
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

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).

Detailed description

1. This is a prospective, randomized, open-label trial with blinded endpoint assessment (PROBE) design. 2. Participants will be randomly assigned in a 1:1 ratio to either an intensive BP control group (targeting a 20% increase from baseline systolic BP, capped at less than 160 mmHg) or a standard BP control group (maintaining systolic BP at or below 180 mmHg). 3. Randomization: Allocation will be stratified by stroke severity (NIHSS \<15 or ≥15) and participating study center. Randomization will be conducted via a web-based system using a pre-generated randomization table created by a statistician. Investigators will enter stratification variables (study center, NIHSS score) into the system to receive the randomized allocation. 4. This is a multi-center prospective study involving patients admitted to participating hospitals for acute ischemic stroke between October 2024 and December 2029 (last visit date). The study will include patients who undergo successful intra-arterial reperfusion therapy based on current stroke guidelines. 5. Data collection will include the medical history, imaging findings, BP parameters (systolic BP, diastolic BP, BP variability), neurological scores, functional recovery, and quality of life (QoL) measures for eligible participants. 6. Neurological scores, functional recovery, and QoL assessments will be conducted by independent evaluators who are blinded to treatment allocation. 7. All data will be collected using electronic case report forms (e-CRF), and anonymized imaging data will be sent to the coordinating center. 8. The coordinating center will perform blinded quantification of imaging results.

Conditions

• Acute Ischemic Stroke

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-10-01
• Primary completion: 2029-12-03
• Completion: 2029-12-03
• First posted: 2024-11-07
• Last updated: 2026-02-13

Locations

1 site across 1 country: South Korea