Key result
Targeting SBP < 120 mmHg evaluates major cardiovascular event reduction after stroke or TIA.
Why the study?
Optimal blood pressure targets in patients with ischaemic stroke or TIA remain uncertain despite evidence supporting intensive BP lowering in high cardiovascular risk populations without prior stroke.
Does an intensive systolic blood pressure target (<120 mmHg) reduce major cardiovascular events compared to a standard target (<140 mmHg) in patients with previous ischaemic stroke or TIA?
RCT (n=4,368)
Open-label with blinded and independent outcome adjudication
1:1 ratio, centrally randomised with concealed allocation, variable block sizes, stratified by study site
Yes
Does an intensive systolic blood pressure target (<120 mmHg) reduce major cardiovascular events compared to a standard target (<140 mmHg) in patients with previous ischaemic stroke or TIA?
The OPTIMAL-STROKE trial will provide adequately powered evidence on whether an intensive systolic blood pressure target below 120 mmHg prevents major cardiovascular events better than a standard target in patients with prior ischaemic stroke or TIA.
Background In high cardiovascular risk populations without prior stroke, intensive blood pressure (BP) lowering confers greater reductions in cardiovascular events than standard targets. However, optimal BP targets in patients with ischaemic stroke (IS) or TIA remain uncertain. The primary objective of the OPTIMAL-STROKE trial is to assess whether an intensive systolic BP (SBP) target (SBP < 120 mmHg) reduces major cardiovascular events in patients with previous IS or TIA compared to a standard SBP target (SBP < 140 mmHg). Study design OPTIMAL-STROKE is a multicentre, randomised, controlled, open-label clinical trial with blinded and independent assessment of clinical outcomes and intention-to-treat primary analysis. Patients with a history of IS or TIA and high BP (SBP of 130–180 mmHg), clinically stable for at least 48 h prior to trial inclusion, are centrally randomised with concealed allocation in a 1:1 ratio to either an intensive BP control strategy targeting a SBP < 120 mmHg or a standard control strategy targeting a SBP < 140 mmHg. A total of 495 primary outcome events, 4368 patients enrolled. Study endpoints The primary outcome is the first occurrence of a composite outcome of major cardiovascular events (cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, hospitalisation for unstable angina or hospitalisation for heart failure). Summary OPTIMAL-STROKE will be the first adequately powered trial of intensive BP control in the prevention of major cardiovascular events in patients with a history of IS or TIA. Trial registration The trial is registered at ClinicalTrials.gov (NCT04036409).
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Silva et al. (2026) conducted an RCT in Ischaemic stroke or transient ischaemic attack (TIA) (n=4,368). Intensive blood pressure control vs. Standard blood pressure control targeting SBP < 140 mmHg was evaluated on Composite of cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, hospitalisation for unstable angina or hospitalisation for heart failure. The OPTIMAL-STROKE trial was designed to evaluate whether targeting a systolic blood pressure < 120 mmHg reduces major cardiovascular events compared to < 140 mmHg in 4,368 patients with prior ischaemic stroke or TIA.
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