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Table 2 Primary and secondary endpoints of the trial

From: Safety and efficacy of glibenclamide combined with rtPA in acute cerebral ischemia with occlusion/stenosis of anterior circulation (SE-GRACE): study protocol for a randomized controlled trial

Outcome

Description

Primary outcome

The ratio of mRS ≤ 2 at 90 days after the stroke onset

Secondary outcome

1. The ratio of NIHSS decreased ≥4 points at 7 days after the stroke onset

2. The ratio of parenchymal hemorrhagic transformation in cranial CT within 96 h after the onset

3. The ratio of midline shift ≥6 mm in cranial CT within 96 h after the onset

4. The mRS shift at 90 days after the onset

5. The ratio of Barthel Index of 60–100 points at 90 days after the onset

6. The proportion of Informant Questionnaire on Cognitive Decline in the Elderly (IQCODE) of ≤3.40 at 6 months and 1 year after the stroke onset

7. The serum concentration of MMP-9 at baseline, and at 24, 48, and 72 h after onset

Safety outcome

1. The mortality at 90 days after the onset

2. The ratio of neurological deterioration (NIHSS increased ≥4 points) within 24 h after the onset

3. The incidence of hypoglycemia (random blood glucose < 3.9 mmol/L)

4. The incidence of cardiac events in cardiac examination (ECG, echocardiography)

5. The incidence of pulmonary infection

6. The incidence of adverse event and serious adverse event