Clinical trial NCT06677970: Outcome in Patients Treated With Endovascular Thrombectomy - optIMAL Blood Pressure Control 2 (OPTIMAL-BP 2)
Official title: Outcome in Patients Treated With Endovascular Thrombectomy - optIMAL Blood Pressure Control 2 (OPTIMAL-BP 2)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Acute Ischemic Stroke
Keywords: Blood pressure
Ischemic stroke
thrombectomy
outcome
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2024-11-07
Enrollment: 176
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: a multicenter, randomized, open Lable, blinded end-point clinical trial.
Primary purpose: TREATMENT

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 those with post-thrombectomy systolic BP below 140 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 180 mmHg) or a standard BP control group (systolic BP 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 systolic BP increase by 20%, with a maximum of 180 mmHg) or a standard BP control group (maintaining systolic BP 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 2028 (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.

Eligibility criteria: Inclusion Criteria:

* Age ≥20 years
* Patients who underwent endovascular thrombectomy for acute ischemic stroke due to large vessel occlusion (ICA, MCA, M1, or M2).
* Successful recanalization of the intracranial artery after endovascular thrombectomy (TICI 2b or TICI 3).
* Patients whose systolic blood pressure was measured to be below 140 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 (TICI ≤ 2a).
* Patients with systolic blood pressure ≥ 140 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 severe medical or surgical conditions, such as terminal cancer (life expectancy ≤ 6 months), severe cardiac or aortic disease, severe hematologic disorders, advanced heart failure, severe pneumonia, or sepsis.
* Patients who do not consent to participate in the study.
* Patients enrolled in other studies that do not allow for concurrent participation.
* Other cases where the investigator deems participation to be difficult.

Primary outcomes:
measure: Functinal independence
timeFrame: 3 months
measure: Symptomatic Intracranial Hemorrhage (sICH)
timeFrame: 36 hours
measure: Stroke related death
timeFrame: 3 months
Secondary outcomes:
measure: Shift analysis of mRS score distribution.
timeFrame: 3 months
measure: Change in NIHSS score 24 hours after endovascular treatment.
timeFrame: 3 months
measure: Major Neurological Improvement at 24 hours, defined as either an NIHSS score of 0-1 or an improvement of 8 or more points.
timeFrame: 3 months
measure: Differences in mRS scores at discharge and at 1 month.
timeFrame: 1 month
measure: Proportion of functional independence at discharge and at 1 month.
timeFrame: 1 month
measure: Assessment of sustained vessel recanalization on CTA/MRA at 24 hours (modified Thrombolysis in Cerebral Infarction [mTICI] grade ≥2b)
timeFrame: 3 months
measure: Differences in blood pressure parameters (systolic BP, diastolic BP, and BP variability).
timeFrame: 3 months
measure: Differences in quality of life based on the Euro-Q5 scale.
timeFrame: 3 months
measure: Differences in causes of death.
timeFrame: 3 months
measure: Proportion of functional independence based on collateral circulation measured by Tan scale (good collateral is defined as Tan scale 2 - 3).
timeFrame: 3 months
measure: Proportion of functional independence according to variability in blood pressure (e.g., standard deviation, coefficient of variation, VIM, successive variation).
timeFrame: 3 months
measure: Proportion of functional independence according to the ASPECTS (Alberta Stroke Program Early CT Score) on CT or MRI.
timeFrame: 3 months
measure: Proportion of functional independence according to prior tPA administration.
timeFrame: 3 months
measure: Proportion of functional independence according to intracranial arterial stenosis.
timeFrame: 3 months
measure: Proportion of functional independence according to multiple attempts at endovascular recanalization.
timeFrame: 3 months
measure: Proportion of functional independence according to achieving the target blood pressure and the time to target on outcomes.
timeFrame: 3 months
measure: Proportion of functional independence according to baseline mTICI scores.
timeFrame: 3 months
measure: Proportion of functional independence according to neurological deterioration (NIHSS worsening by ≥ 4 points).
timeFrame: 3 months
measure: Proportion of functional independence according to the occluded vessel involved.
timeFrame: 3 months
measure: Proportion of functional independence according to laboratory findings (including D-dimer, CRP, glucose).
timeFrame: 3 months
measure: Proportion of functional independence according to estimated pulse wave velocity (ePWV).
timeFrame: 3 months
measure: Optimal target BP according to AI predicting for functional independence in 10 mmHg increments
timeFrame: 3 months
measure: Occurrence of adverse event
timeFrame: 24 hours
measure: Treatment failure, defined as failure to achieve target blood pressure on two consecutive measurements within 24 hours after endovascular therapy.
timeFrame: 24 hours
measure: Differences in BP variability depending on the antihypertensive agent use (labetalol or nicardipine).
timeFrame: 24 hours
measure: Incidence of malignant cerebral edema.
timeFrame: 36hours to 1 week
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Neurology, Yonsei University College of Medicine
Study officials:
References: