TABLE 2.
Comparison of primary outcome and secondary outcome
| Variable |
Ginkgolide N = 463 |
Placebo N = 473 |
RR | 95% CI | p value |
|---|---|---|---|---|---|
| Primary outcome a | 0 (0.00%) | 6 (1.27%) | 1.013 | 1.002–1.023 | 0.031 |
| Mortality | 0 (0.00%) | 2 (0.42%) | 1.004 | 0.998–1.010 | 0.500 |
| Recurrent stroke | 0 (0.00%) | 4 (0.85%) | 1.008 | 1.002–1.017 | 0.124 |
| SAE | 5 (1.08%) | 3 (0.63%) | 1.703 | 0.409–7.084 | 0.502 |
| Secondary outcome at 28 days | |||||
| mRS 0–1 | 293/463 (71.3%) | 312/473 (71.5%) | 0.989 | 0.734–1.331 | 0.940 |
| mRS 0–2 | 362/463 (78.2%) | 362/473 (76.5%) | 1.492 | 1.013–2.198 | 0.042 |
| NIHSS improvement b | 3.73 ± 2.24 | 3.36 ± 2.28 | 0.370 | 0.071–0.681 | 0.016 |
| Platelet aggregation pathways results at 14 days | |||||
| PAF, pg/ml b | 285.72 ± 276.05 | 347.75 ± 489.79 | −62.030 | −120.593– −3.467 | 0.036 |
| ADP, ng/ml b | 294.21 ± 254.52 | 319.32 ± 387.75 | −25.104 | −73.351–23.142 | 0.304 |
| TAX2, pg/ml b | 1314.02 ± 2893.23 | 1244.34 ± 2629.64 | 70.012 | −334.775–474.499 | 0.734 |
Abbreviations: ADP, adenosine‐5’‐diphosphate (ADP); CI, confidential interval; mRS, modified Rankin Scale; NIHSS, National Institution of Health Stroke Scale; PAF, platelet aggregation factor; RR, risk ratio; SAE, severe adverse event; TXA2, thromboxane A2.
a
Composite index event was consisted with recurrent ischemic stroke, hemorrhage stroke, and mortality caused by vascular event.
b
The NIHSS improvement between the baseline NIHSS and the performance at 28 days and all levels of platelet aggregation pathway at 14 days were presented by 95% CI difference and analyzed by linear regression, presented with mean ± SD and coef.