Outcome in Patients Treated With Endovascular Thrombectomy - optIMAL Blood Pressure Control 2 (OPTIMAL-BP 2)
Yonsei University
176 participants
Oct 1, 2024
INTERVENTIONAL
Conditions
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).
Eligibility
Inclusion Criteria5
- 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).
Exclusion Criteria17
- 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 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.
- Patients with persistent bradycardia with a heart rate <45 bpm.
- Pregnant patients.
- 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.
- Patients who do not consent to participate in the study.
- Patients participating in another study that does not allow co-enrollment.
- Patients whom the investigator deems unsuitable for study participation for any reason.
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Interventions
After successful reperfusion, appropriate antihypertension medication is administered to control systolic blood pressure \<180 mmHg.
After successful reperfusion, appropriate BP raising (20% increase in SBP, maximum of 160 from baseline SBP) are administered.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06677970