Aggrenox®

Swedish Headache Study

Methods

The study was designed as a randomised, open, blinded point evalution pilot study performed in two hospitals. Fifty-seven patients with stroke or TIA within 3 months were included for analysis. The patients received ASA for 6 days and were then randomised to either (1) standard treatment with the combination of ASA 25 mg and modified-release dipyramidole 200 mg, b.i.d or (2) titration treatment with ASA 75 mg only in the morning and combined ASA 25 mg and modified-release dipyramidole 200 mg in the evening for 5 days. All patients thereafter received standard treatment of ASA and dipyridamole until day 20. The patients completed a dairy with information about possible symptoms (if any) during the 20 day study period and returned with the diary to be blinded investigator on day 20. The primary point of the study was: Proportion of patients with moderate to severe headache during day 7-20. Several secondary points related the headache were also defined.

Inclusion and Exclusion of Patients