Table 3.
Safety End Points and Other SAEs*
| rt-PA+Eptifibatide (n=101) | rt-PA (n=25) | Odds Ratio (95% CI) | P Value | |
|---|---|---|---|---|
| Prespecified primary safety end point | ||||
| Symptomatic ICH in 36 h, n (%) | 2 (2.0) | 3 (12.0) | 0.15 (0.01–1.40)† | 0.053 |
| Other end points | ||||
| Asymptomatic ICH in 36 h, n (%) | 14 (13.9) | 3 (12.0) | 1.18 (0.29–6.95)† | 1.00 |
| Any ICH in 36 h, n (%) | 16 (15.8) | 6 (24.0) | 0.60 (0.21–1.72) | 0.34 |
| Fatal ICH in 36 h, n (%) | 1 (1.0) | 1 (4.0) | 0.24 (0.003–19.62)† | 0.36 |
| Safety end points in 7 d | ||||
| Symptomatic ICH, n (%) | 2 (2.0) | 3 (12.0) | 0.15 (0.01–1.40)† | 0.053 |
| Asymptomatic ICH, n (%) | 16 (15.8) | 3 (12.0) | 1.38 (0.35–8.02) | 0.76 |
| PH-1, n(%) | 6 (5.9) | 3 (12.0) | 0.47 (0.09–3.10)† | 0.38 |
| PH-2, n (%) | 1 (1.0) | 2 (8.0) | 0.12 (0.002–2.35)† | 0.10 |
| Life-threatening systemic bleed (≥2 U packed red blood cells required) |
1 (1.0%) | 0 | not estimable | 1.00 |
| Moderate bleeding* | 4 (4.0%) | 0 | not estimable | 0.58 |
| Mild bleeding* | 12 (11.9%) | 0 | not estimable | 0.12 |
| Death of any cause, n (%) | 12 (11.9) | 3 (12.0) | 0.99 (0.24–5.92)† | 1.00 |
| Death caused by stroke, n (%) | 12 (11.9) | 3 (12.0) | 0.99 (0.24–5.92)† | 1.00 |
| Safety end points in 90 d | ||||
| Death of any cause, n (%) | 20 (19.8) | 4 (16.0) | 1.29 (0.38–5.76)† | 0.78 |
| Death caused by stroke, n (%) | 15 (14.8) | 4 (16.0) | 0.92 (0.26–4.18)† | 1.00 |
| AE rate | 2.59 (2.01–3.33) [223 events] | 2.82 (1.75–4.56) [62 events] | 0.76 | |
| Subjects with ≥1 AE, n (%) | 83 (82.2) | 19 (76.0) | 1.46 (0.51–4.16) | 0.48 |
| SAE rate | 0.40 (0.26–0.60) [34 events] | 0.36 (0.15–0.86) [8 events] | 0.87 | |
| Subjects with ≥1 SAE, n (%) | 26 (25.7) | 7 (28.0) | 0.89 (0.33–2.38) | 0.82 |
AE indicates adverse events; CI, confidence interval; ICH, intracranial hemorrhage; rt-PA, recombinant tissue plasminogen activator; and SAE, serious AE.
*
Events are not mutually exclusive.
†
Exact logistic and CI.