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

Yonsei University

Status and phase: Enrolling; Phase 3

Conditions: Acute Ischemic Stroke

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

Study type: Interventional

Funder types: Other

Identifiers

NCT06677970

4-2024-0880

Details and patient eligibility

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 those with post-thrombectomy systolic BP below 150 mmHg.

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).

Full 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.

Enrollment: 176 estimated patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age ≥20 years
• Patients who underwent endovascular thrombectomy for acute ischemic stroke due to large vessel occlusion (ICA, M1, M2, A1, P1, and VBA).
• Successful recanalization of the intracranial artery after endovascular thrombectomy (modified TICI 2b, 2c or TICI 3).
• Patients whose mean systolic blood pressure was measured to be below 150 mmHg on at least two occasions, taken 2 minutes apart, within 2 hours of successful recanalization.

Exclusion criteria

• 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 pre-existing neurological deficits (modified Rankin Scale, mRS ≥ 3).
• Patients with heart failure with reduced ejection fraction, defined as an ejection fraction <30%.
• Patients with end-stage renal disease requiring renal replacement therapy or chronic kidney disease stage 4 with an estimated glomerular filtration rate (eGFR) <30 mL/min.
• Patients receiving MAO inhibitors.
• Patients who are currently pregnant.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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176 participants in 2 patient groups

Conventional BP magnagement group (SBP ≤180 mmHg)

Active Comparator group

Treatment:

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

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

Active Comparator group

Treatment:

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