Table 1 Inclusion and exclusion criteria for the SE-GRACE trial
Criteria | Description |
|---|---|
Inclusion criteria | 1. Clinical diagnosis of acute ischemic stroke in the MCA territory (PCA and/or ACA territory involvement in addition to primary MCA territory stroke is acceptable) |
2. Aged ≥18 and ≤ 74 years | |
3. A baseline NIHSS score between 4 to 25 | |
4. Intravenous rt-PA thrombolysis conducted within 4.5 h after stroke onset, if known, or the time last seen well [termed “time last known at neurologic baseline” (TLK@B)] | |
5. The time to the start of administration of Study Drug must be ≤10 h after time of symptom onset or TLK@B | |
6. Informed consent was signed by the subject or the legal representative | |
Exclusion criteria | 1. Prior to stroke, significant disability exist, with modified Rankin Scale > 1 point |
2. With medical history or evidence of cerebral hemorrhage, subarachnoid hemorrhage, arteriovenous malformation, cerebral aneurysm or brain tumor | |
3. With clinical or imaging evidence of contralateral cerebral infarction which is believed to have influence on the patient outcome by the investigators | |
4. With clinical or imaging evidence of occlusion in vertebral or basilar artery | |
5. With clinical evidence of brain herniation, e.g., one or two dilated, fixed pupils; unconsciousness (i.e., C2 on item 1a on the NIHSS); and/or loss of other brainstem reflexes, attributable to edema or herniation according to the investigator’s judgment | |
6. With gastrointestinal bleeding and instable hemodynamics or other causes that force the patient to stop nutritional support | |
7. Renal disorder from the patient’s history (e.g., dialysis) or eGFR of < 60 mL/min/1.73 m2 | |
8. Severe liver disease, or ALT > 3 times upper limit of normal or bilirubin > 2 times normal (subjects may be randomized if liver function tests have been drawn but are not yet available and the subject has no known history of liver disease; however treatment with Study Drug cannot commence until liver function tests are available and indicate ALT > 3 times upper limit of normal and bilirubin B2 times upper limit of normal) | |
9. Blood glucose < 3.0 mmol/L at enrollment or immediately prior to administration of Study Drug, or a clinically significant history of hypoglycemia | |
10. Acute ST elevation myocardial infarction, and/or acute decompensated heart failure, and/or Tc > 520 ms, and/or known history of cardiac arrest (PEA, VT, VF, asystole), and/or admission for an acute coronary syndrome, myocardial infarction, or coronary intervention within the past 3 months | |
11. Known sulfonylurea treatment within 7 days. Sulfonylureas include glibenclamide/glyburide; glibenclamide plus metformin; Xiaoke Pill (a Chinese patent medicine with main effective constituent of glibenclamide); glimepiride; repaglinide; nateglinide; glipizide; gliclazide; tolbutamide; glibornuride | |
12. Known treatment with bosentan within 7 days | |
13. Known allergy to sulfa or specific allergy to sulfonylurea drugs | |
14. Known G6PD enzyme deficiency | |
15. Pregnant women. Women must be either postmenopausal (as confirmed by the LAR), permanently sterilized or, if ≤50 years old must have a negative test for pregnancy obtained before enrollment | |
16. Breast-feeding women who do not agree (or their LAR does not agree) to stop breastfeeding during Study Drug infusion and for 7 days following the end of Study Drug infusion | |
17. Patients already enrolled in a non-observation-only stroke study, or with life-expectancy < 6 months not related to current stroke, or those unlikely to be compliant with follow up | |
18. Patients currently receiving an investigational drug | |
19. Mentally incompetent (prior to qualifying stroke) patients and wards of the state | |
20. Patients who, in the opinion of the investigator, are not suitable for the study (reason to be documented) |