From: Meta-analysis of randomized phase II trials to inform subsequent phase III decisions
Trial name, year published | Length of follow-up | Outcome | Sample size, N | Number of events (%) | ||
---|---|---|---|---|---|---|
Bolus | Infusion | Bolus | Infusion | |||
Phase II trials | Â | Â | Â | Â | Â | Â |
RAPID [11] 1995 | 30Â days | ICH | 452 | 154 | 1 (0.2) | 4 (2.6) |
Reinfarction | 20 (4.4) | 7 (4.5) | ||||
RAPID-II [12] 1996 | 35Â days | ICH | 169 | 155 | 2 (1.2) | 3 (1.9) |
Reinfarction | 8 (4.7) | 7 (4.5) | ||||
Kawai et al. [13] 1997 | 7Â days | ICH | 97 | 102 | 0 (0) | 1 (1.0) |
Reinfarction | 4 (4.1) | 7 (6.9) | ||||
Vanderschueren et al. [14] 1997 | Hospital stay | ICH | 50 | 52 | 0 (0) | 0 (0) |
Reinfarction | 5 (10.0) | 7 (13.4) | ||||
BASE [15] 1998 | Hospital stay | ICH | 139 | 53 | 2 (1.4) | 0 (0) |
Reinfarction | 9 (6.5) | 1 (1.9) | ||||
DOUBLE [16] 1998 | 30Â days | ICH | 224 | 237 | 2 (0.9) | 1 (0.4) |
Reinfarction | 5 (2.2) | 12 (5.1) | ||||
lnTIME [17] 1998 | 30Â days | ICH | 478 | 124 | 0 (0) | 1 (0.8) |
Reinfarction | 9 (1.9) | 8 (6.5) | ||||
TIMI 10B [18] 1998 | 30Â days | ICH | 540 | 316 | 9 (1.7) | 6 (1.9) |
Reinfarction | 28 (5.2) | 18 (5.7) | ||||
TIMIKO [19] 1998 | 30Â days | ICH | 350 | 268 | 1 (0.3) | 3 (1.1) |
Reinfarction | 11 (3.1) | 9 (3.4) | ||||
Phase III trials | Â | Â | Â | Â | Â | Â |
INJECT [22] 1995 | 35Â days | ICH | 2992 | 2994 | 23 (0.8) | 11 (0.4) |
Reinfarction | 150 (5.0) | 162 (5.4) | ||||
COBALT [23] 1997 | 30Â days | ICH | 3585 | 3584 | 40 (1.1) | 29 (0.8) |
Reinfarction | 140 (3.9) | 147 (4.1) | ||||
GUSTO III [24] 1997 | 30Â days | ICH | 10138 | 4921 | 92 (0.9) | 43 (0.9) |
Reinfarction | 426 (8.7) | 207 (2.0) | ||||
BIRD [26] 1998 | 30Â days | ICH | 1196 | 1212 | 9 (0.8) | 9 (0.7) |
Reinfarction | - | - | ||||
ASSENT-2 [25] 1999 | 30Â days | ICH | 8461 | 8488 | 79 (0.9) | 80 (0.9) |
Reinfarction | 347 (4.1) | 325 (3.8) | ||||
lnTIME-II [27] 1999 | 30Â days | ICH | 10051 | 5027 | 114 (1.1) | 31 (0.6) |
Reinfarction | - | - |