Table 3.
Results of pre-specified exploratory and post-hoc analyses. Unless specified otherwise, all analyses are adjusted for stratification variables. Abbreviations: SITS-MOST–Safe Implementation of Thrombolysis in Stroke-Monitoring Study. Abbreviations: CrI–credible interval, CI–confidence interval.
Control rt-PA-alone N=29 |
Low-Dose Argatroban + rt-PA N=30 |
High-Dose Argatroban + rt-PA N=31 |
Low + High-Dose Argatroban + rt-PA N=61 |
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PRESPECIFIED EXPLORATORY ANALYSIS | ||||
mRS 0–1 at 90-days adjusted for stratification variables, age and NIHSS | ||||
RR (95% CrI), probability RR>1.0 | – | 1.17 (0.56, 2.4), 0.66 | 1.07 (0.53, 2.16), 0.58 | 1.18 (0.59, 2.43), 0.67 |
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POST HOC ANALYSES | ||||
mRS 0–1 at 90-days | ||||
1) * Ordinal Logistic Regression OR (95% CI), p-value | – | 1.23 (0.49, 3.07), 0.66 | 2.03 (0.8, 5.1), 0.13 | 1.58 (0.71, 3.50), 0.26 |
2) * Poisson Regression RR (95% CI), p-value | – | 1.50 (0.64, 3.49), 0.35 | 1.63 (0.72, 3.72), 0.24 | 1.57 (0.74, 3.33), 0.24 |
Symptomatic Intracerebral Hemorrhage | ||||
3) Intention To Treat (ITT) N(%), 95% CI | 3(10), 2.2–27.4 | 4(13), 3.8–30.7 | 2(7), 0.8–21.4 | 6(10), 3.7–20.2 |
* RR (95% CI), p-value | – | 1.27 (0.32-5.1), 0.74 | 0.60 (0.11-3.41), 0.56 | 0.93 (0.25-3.48), 0.91 |
As Treated N(%), 95% CI | 4(13), 3.8–30.7 | 4(13), 3.8–30.7 | 1(3), 0.1–17.2 | 5(8), 2.8–18.4 |
* RR (95% CI), p-value | – | 0.98 (0.28–3.47), 0.97 | 0.24 (0.03–2.07), 0.19 | 0.60 (0.17–2.11), 0.43 |
SITS-MOST Definition (ITT) N(%), 95% CI | 0 | 1(3), 0.1–17.2 | 2(7), 0.8–21.4 | 3(5), 1.0–13.7 |
SITS-MOST Definition (As Treated) N(%), 95% CI | 1(3), 0.1–17.2 | 1(3), 0.1–17.2 | 1(3), 0.1–17.2 | 2(3), 0.4–11.5 |
4) †Neutral Prior Bayesian RR (95% CrI), probability RR>1.0 | – | 1.17 (0.48, 2.75), 0.63 | 0.82 (0.33, 2.0), 0.34 | 0.98 (0.42, 2.4), 0.48 |
Frequentist Poisson Regression.
Neutral Prior: RR=1.0 and 95% predictive interval: 0.33–3.0.