Objective. To evaluate the relationship between high initial blood pressure and functional outcome in patients with acute stroke. Design. An observational study based on the data from the Intravenous Nimodipine West European Stroke Trial (INWEST), INWEST was a placebo-controlled randomized study terminated prematurely; subsequent analysis found a correlation between diastolic BP (DBP) reduction caused by high-dose nimodipine and unfavourable outcome. Subjects. Of the 295 patients with acute ischaemic stroke (within 24 h) recruited in the INWEST, 265 were included in this analysis [n = 92 for placebo, n = 93 for low-dose nimodipine (1-mg h(-1)) and n = 80 for high-dose nimodipine (2-mg h(-1))]. Definition, Initial BP was defined as BP at the time of randomization. Normal initial BP (NIBP) = systolic BP (SBP) 120-160 and DBP 60-90 mmHg (n = 126). Four alternatives were defined as high initial BP (HIBP): (1) >160/90 (n = 126), (2) >170/95 (n = 106), (3) >180/100 (n = 63), (4) >190/105 (n = 45). Main outcome measures. Combined death or dependency (DD) (Barthel index < 60) at 21 days. Results. In multiple logistic regression analyses, the odds ratio [OR] for DD at day 21 was significantly higher in patients with any definition of HIBP than with NIBP. For all patients, OR and 95% confidence intervals [CI]for 160/90 versus NIBP = 3.1, 1.3-7.3, respectively; for 170/95 = 3.3, 1.4-8.1; for 180/100 = 7.0, 2.1-22.8; for 190/105 = 3.7, 1.1-12.4. For only placebo patients, OR and 95% CI for 160/90 = 4.8, 1.2-19.3; for 170/95 = 4.4, 1.1-17.8; for 180/100 = 12.7, 2.2-74.7; for 190/105 = 5.6, 1.1-30.0. The outcome was similar at 24 weeks but did not reach statistical significance for the placebo patients. Conclusion. Patients with HIBP had a poor functional outcome after acute stroke.