Efficacy and safety end points
| Placebo (n=11) | Lefradafiban dose (× 3 daily) | ||||
|---|---|---|---|---|---|
| 30 mg (n=16) | 45 mg (n=16) | 60 mg (n=21) | |||
| Efficacy indices | |||||
| Plasma concentration of fradafiban (ng/ml)2-150 | 0 | 158 (27) | 314 (24) | 394 (22) | |
| FRO (%)—minimum | 0 | 54 | 74 | 78 | |
| FRO (%)—median | 0 | 71 | 85 | 88 | |
| FRO (%)—maximum | 0 | 80 | 89 | 95 | |
| FRO (%)—mean2-151 | 0 | 69 (12) | 83 (6) | 87 (5) | |
| Bleeding time | |||||
| At baseline (min) | 3.3 | 4.0 | 4.1 | 5.3 | |
| After 48 hours (min) | 4.4 | 7.8 | 19.2 | 25.0 | |
| Bleeding complications | |||||
| Patients with bleeding, n (%) | 1 (9) | 7 (44) | 7 (44) | 15 (71) | |
| Number of bleeding events (n) | 1 | 8 | 9 | 29 | |
| Location of bleeding (n) | |||||
| Vascular puncture site | 1 | 6 | 6 | 15 | |
| Gingival | – | 1 | 2 | 10 | |
| Skin | – | 1 | 1 | 2 | |
| Haematuria | – | – | – | 2 | |
| Severity of bleeding by TIMI (n) | |||||
| Major | – | – | – | – | |
| Minor | – | – | 1 | 2 | |
| Insignificant | 1 | 8 | 8 | 27 | |
↵2-150 Mean maximum fradafiban plasma concentration at steady state (Cmax,ss) with the relative coefficient of variation (%) in parentheses.
↵2-151 Relative coefficient of variation (%) in parentheses.
All FRO values are expressed as area under the curve normalised per hour. Relative coefficient of variation = 100 × (standard deviation/mean).