- Question
- Does intensive blood pressure lowering in patients with acute ischaemic stroke treated with alteplase improve functional outcome compared with guideline-recommended blood pressure management?
- Design
- International, partial-factorial, open-label, blinded-endpoint phase 3 trial that randomised patients 1:1 across 110 sites in 15 countries, with 2196 analysed. Randomisation occurred within 6 h of stroke onset, with blood pressure management over 72 h.
- Population
- Adults with acute ischaemic stroke eligible for alteplase thrombolysis and a systolic blood pressure of 150 mm Hg or more. Median time from stroke onset to randomisation was 3.3 h.
- Intervention
- Intensive blood pressure lowering, targeting a systolic pressure of 130-140 mm Hg within the first hour and maintained over 72 h.
- Control
- Guideline-based antihypertensive treatment, targeting a systolic pressure below 180 mm Hg over 72 h.
- Primary outcome
- Functional status at 90 days measured by the shift in modified Rankin scale score distribution, analysed with unadjusted ordinal logistic regression.
- Results
- The modified Rankin scale distribution at 90 days did not differ between groups (unadjusted OR 1.01; 95% CI 0.87-1.17; p=0.8702). Mean 24-h systolic blood pressure was 144.3 mm Hg with intensive treatment and 149.8 mm Hg with guideline treatment. Any intracranial haemorrhage was less frequent in the intensive group (14.8% vs 18.7%; OR 0.75; 95% CI 0.60-0.94; p=0.0137).
- Safety
- Serious adverse events did not differ significantly between the intensive group (19.4%) and the guideline group (22.0%; OR 0.86; 95% CI 0.70-1.05; p=0.1412). There was no interaction with alteplase dose (low vs standard) for the primary outcome.
- Conclusion
- Intensive blood pressure lowering was safe and reduced intracranial haemorrhage, but this did not translate into better functional outcome than guideline-based management.
- Why it matters
- The trial did not support a major shift toward intensive blood pressure lowering in patients with mild-to-moderate ischaemic stroke receiving alteplase, and highlighted the need to study the mechanisms of benefit and harm of early lowering.
Card generated automatically with AI from the abstract of the original publication and the trial registry; every figure was checked against those sources. It may contain errors: verify the data at the source before using it for clinical decisions.
Generated on October 14, 2026