A randomized trial comparing ticlopidine hydrochloride with indobufen for the prevention of stroke in high-risk patients (TISS Study). Ticlopidine Indobufen Stroke Study.

Two treatments, based on either ticlopidine or indobufen at their optimal individual daily dose (median dose: 250 and 200 mg/day, respectively), were compared in an open randomized multicenter trial in patients at risk of cerebral ischemia (men and women, aged 39 to 80 years, who had experienced in the month before entry into the study transient ischemic attack or amaurosis fugax or minor stroke). The total number of patients screened was 4033; 1632 were enrolled, 821 randomized to ticlopidine, 811 to indobufen. The overall frequency of the composite primary end-point (stroke, myocardial infarction, and death from any cause) was 4.4%. The ticlopidine-based regimen proved significantly better than the indobufen one in preventing the composite of fatal and non fatal events (49.6% relative risk reduction), or death alone (54.4% relative risk reduction). The two groups had similar percentages of adverse events (5.5% and 6.4% for ticlopidine and indobufen group, respectively) with withdrawals because of adverse events in 3.4% and 2.5%; gastrointestinal disorders and bleeding were more frequent in the indobufen group, whereas rash and abnormal liver function were more frequent in the ticlopidine one.