Outcome in Patients Treated With Endovascular Thrombectomy - optIMAL Blood Pressure Control 2 (OPTIMAL-BP 2)
概览
- 阶段
- 3 期
- 干预措施
- BP lowering drugs (nicardipine, labetalol, urapidil)
- 疾病 / 适应症
- Acute Ischemic Stroke
- 发起方
- Yonsei University
- 入组人数
- 176
- 试验地点
- 1
- 主要终点
- Functinal independence
- 状态
- 招募中
- 最后更新
- 2个月前
概览
简要总结
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).
详细描述
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.
研究者
入排标准
入选标准
- •\<Inclusion Criteria\>
- •Age ≥20 years
- •Acute ischemic stroke patients who underwent intraarterial thrombectomy for large vessel occlusion. (ICA, M1, M2, A1, P1, VA and BA)
- •Patients with successful recanalization after intraarterial thrombectomy (TICI 2b or TICI 3)
- •Patients with sustained systolic blood pressure (SBP) \<150 mm Hg on successive measurements obtained less than 10 minutes apart within 3 hours after reperfusion.
- •Patients with mean SBP \<150 mmHg within 2 hours after successful recanalization (two measurements ≥2 minutes apart).
排除标准
- •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 contraindications to Phenylephrine.
- •Patients with contraindications to antihypertensive medications.
- •Patients with pre-stroke functional disability (modified Rankin Scale, mRS ≥3).
- •Patients with heart failure and reduced cardiac output, with an ejection fraction (EF) \<40%.
- •Patients with end-stage renal disease requiring renal replacement therapy, or chronic kidney disease stage 4 with an eGFR \<30 mL/min.
- •Patients currently taking monoamine oxidase (MAO) inhibitors.
研究组 & 干预措施
Conventional BP magnagement group (SBP ≤180 mmHg)
干预措施: BP lowering drugs (nicardipine, labetalol, urapidil)
Intensive BP raising group (20% increase in SBP, maximum of 160 mmHg )
干预措施: BP raising drug (phenylephrine) or BP lowering drugs (nicardipine, labetalol, urapidil)
结局指标
主要结局
Functinal independence
时间窗: 3 months
Proportion of patients with a functional independence (defined as mRS ≤ 2) at 3 months, assessed using the modified Rankin Scale (mRS).
Symptomatic Intracranial Hemorrhage (sICH)
时间窗: 36 hours
Symptomatic Intracranial Hemorrhage (sICH) after Endovascular Treatment Intracranial hemorrhage or hemorrhagic transformation identified on MRI (GRE or SWI) or CT within 24 ± 12 hours or due to clinical worsening. (Symptomatic intracranial hemorrhage is defined according to the European Cooperative Acute Stroke Study III \[ECASS III\] criteria)
Stroke related death
时间窗: 3 months
Stroke related death within 3 months
次要结局
- Evaluation of vascular stiffness as a determinant of post-EVT outcomes.(3 months)
- Biochemical markers including D-dimer, CRP, or glucose(3 months)
- Shift analysis of mRS score distribution.(3 months)
- NIHSS score at 24 hours after endovascular treatment.(24 hours)
- Major Neurological Improvement at 24 hours, defined as either an NIHSS score of 0-1 or an improvement of 8 or more points.(3 months)
- Sustained vessel recanalization on CTA/MRA at 24 hours(Discharge and 1 month)
- Proportion of functional independence at 1 month.(3 months)
- Differences in Euro-Q5 instrument.(36 hours to 1 week)
- Incidence of malignant cerebral edema.(36 hours)
- Infarction volumes(36 hours)
- Using intravenous BP lowering drug(3 months)
- Medication induced BP drop(3 months)
- Collateral circulation measured by Tan scale (good collateral is defined as Tan scale 2-3) in baseline CTA.(3 months)
- Variability in blood pressure (e.g., standard deviation, coefficient of variation, VIM, successive variation, and threshold).(3 months)
- Outcome comparison by baseline ischemic core burden measured with ASPECTS.(3 months)
- Evaluation of differential outcomes in patients who received IV tPA before EVT.(3 months)
- Comparison of outcomes according to presence or severity of intracranial atherosclerotic stenosis.(3 months)
- Assessment of outcome differences by number of thrombectomy passes.(3 months)
- Evaluation of outcomes relative to attainment and timing of post-EVT BP target.(3 months)
- Outcome comparison by initial angiographic reperfusion grade before BP intervention.(3 months)
- Assessment of outcome differences between patients with and without early neurological worsening.(3 months)
- Evaluation of outcomes stratified by occlusion site (e.g., ICA, M1, M2).(3 months)
- Small artery disease - white matter hyperintensity(3 months)
- Small artery disease - microbleeds(3 months)
- Small artery disease - old lacunar infarction(3 months)
- Optimal target BP according to AI predicting for functional independence in 10 mmHg increments(3 months)
- Occurrence of adverse event or serious adverse event(3 months)
- Treatment failure, defined as failure to achieve target blood pressure on two consecutive measurements within 24 hours after endovascular therapy.(24 hours)
- Differences in BP variability depending on the antihypertensive agent use (labetalol or nicardipine).(24 hours)
- Differences in causes of death.(3 months)
- Diffrences in fuctional outcomes at 1 year.(1 year)
- Euro-Q5-5L analogue scale.(1 year)