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Design of the BEST-II Randomized Clinical Trial
Eva A Mistry1, Kimberly Hart2, Taylor Davis3
1Department of Neurology and Rehabilitation Medicine University of Cincinnati Cincinnati OH.
Stroke (Hoboken, N.J.)
|January 26, 2026
Summary
The Blood Pressure After Endovascular Stroke Therapy-II (BEST-II) trial investigates lower systolic blood pressure targets after stroke treatment. Results will guide future research on safe and effective blood pressure management post-endovascular therapy.
Area of Science:
- Neurology
- Cardiology
- Clinical Trials
Background:
- Observational studies suggest lower systolic blood pressure (SBP) post-endovascular treatment (EVT) correlates with better outcomes in acute ischemic stroke patients.
- However, the safety and efficacy of targeting SBP below the guideline-recommended 180 mm Hg remain unconfirmed.
Purpose of the Study:
- To compare the safety of lower versus higher SBP targets in patients who have undergone successful EVT.
- To inform the design and estimate the success probability of a future Phase 3 trial.
Main Methods:
- The BEST-II trial is a randomized, open-label, phase 2 trial involving 120 patients with acute ischemic stroke.
- Patients with successful EVT will be randomized to SBP targets of ≤180, <160, or <140 mm Hg for 24 hours, managed with nicardipine.
- Primary outcomes include final infarct volume and utility-weighted modified Rankin Scale score at 90 days.
Main Results:
- Enrollment began in January 2020, with 90 patients enrolled by October 2021.
- The trial is progressing ahead of schedule, with anticipated completion before January 2023.
Conclusions:
- The BEST-II trial will provide crucial data on the safety of lower SBP targets post-EVT for acute ischemic stroke.
- Findings will demonstrate the feasibility of achieving these targets and conducting further efficacy trials, even amidst the COVID-19 pandemic.
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