Meta-analysis of randomized phase II trials to inform subsequent phase III decisions

Burke, Danielle L; Billingham, Lucinda J; Girling, Alan J; Riley, Richard D

doi:10.1186/1745-6215-15-346

Trials

Table 1 Phase II and Phase III randomized trials of bolus versus infusion thrombolytic therapy for acute myocardial infarction

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

ICH, intracranial hemorrhage.

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ISSN: 1745-6215

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