Intensive blood-pressure control for the prevention of major cardiovascular events in stroke patients: rationale and design of the OPTIMAL-STROKE trial.

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).