Effect of intravenous urokinase vs best medicine treatment on functional outcome for patients with acute minor stroke (TRUST): a randomized controlled trial

Table 2 Efficacy and safety outcomes in the intention-to-treatment population

	No. (%)
Outcome	Urokinase (n = 503)	Antiplatelet (n = 496)	Effect measure	Treatment effect (95% CI)^a	P value
Primary efficacy outcome
mRS score^b 0–1 at 90 days	427 (84.9)	425 (85.7)	Risk ratio	1.00 (0.96 to 1.05)	0.87
mRS score^b 0–1 at 90 days			Odds ratio	1.06 (0.73 to 1.53)	0.76
Secondary efficacy outcomes
New vascular events within 90 days	33 (6.6)	37 (7.5)	Risk ratio	0.91 (0.58 to 1.44)	0.68
New vascular events within 90 days			Odds ratio	0.91 (0.55 to 1.49)	0.70
Shift mRS			Common odds ratio	1.22 (0.95 to 1.55)	0.12
0	271 (53.9)	253 (51.0)
1	156 (31.0)	172 (34.7)
2	43 (8.5)	29 (5.8)
3	18 (3.6)	17 (3.4)
4	7 (1.4)	8 (1.6)
5	1 (0.2)	4 (0.8)
6	7 (1.4)	13 (2.6)
Barthel Index ≥ 95 at 90 days	280 (56.2)	279 (57.4)	Risk ratio	1.01 (0.94 to 1.09)	0.72
Barthel Index ≥ 95 at 90 days			Odds ratio	1.08 (0.83 to 1.40)	0.58
EQ-5D^c score at 90, mean ± SD	85.5 ± 22.4	86.4 ± 20.8	Mean difference	− 0.20 (− 2.90 to 2.49)	0.88
Safety Outcomes
sICH^d within 36 h	3 (0.6)	1 (0.2)	Risk ratio	1.83 (0.16 to 20.27)	0.62
sICH^d within 36 h			Odds ratio	1.85 (0.17 to 20.77)	0.62
Overall mortality within 90 days	7 (1.4)	13 (2.6)	Risk ratio	0.52 (0.21 to 1.33)	0.18
Overall mortality within 90 days			Odds ratio	0.50 (0.19 to 1.29)	0.15
Adverse events	70 (13.9)	71 (14.3)	Risk ratio	0.97 (0.71 to 1.32)	0.84
Adverse events			Odds ratio	0.97 (0.67 to 1.39)	0.86
Serious adverse events	18 (3.6)	28 (5.6)	Risk ratio	0.61 (0.34 to 1.10)	0.10
Serious adverse events			Odds ratio	0.61 (0.33 to 1.13)	0.12

Abbreviations: mRS modified Rankin scale, SD standard deviation, sICH symptomatic intracranial hemorrhage, AE adverse events, SAE serious adverse events
^aTreatment effects for the urokinase group as compared with the antiplatelet group were adjusted for age, gender, systolic blood pressure, baseline National Institutes of Health Stroke Scale (NIHSS) score, and myocardial infarction
^bModified Rankin scale (mRS) scores range from 0 to 6. 0, no symptoms; 1, symptom without significant disability; 2, slight disability; 3, moderate disability; 4, moderately severe disability; 5, severe disability; and 6, death
^cTotal scores on the EuroQol 5-Dimension questionnaire (EQ-5D) range from 0 to 100, with higher scores indicating a better quality of life across the five dimensions of mobility, self-care, usual activities, pain or discomfort, and anxiety or depression
^dSymptomatic intracerebral hemorrhage (sICH) was defined by National Institute of Neurological Disorders and Stroke (NINDS) criteria: clinical findings of progression plus imaging evidence of hemorrhage within 36 h of thrombolysis, or deterioration in NIHSS score of ≥ 4 with a radiological parenchymal hemorrhage type 2

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