NCT03284463已完成2 期
Safety and Efficacy of Glibenclamide Combined With Rt-PA in Treating Acute Ischemic Stroke: a Prospective, Randomized, Double-blind, Placebo-control, Multi-center Study
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 306
- 试验地点
- 8
- 主要终点
- Functional outcome: The proportion of mordified Rankin Scale of 0 to 2 points
研究概览
简要总结
This study is designed to evaluate the safety and efficacy of oral glibenclamide in acute ischemic stroke patients who under intravenous rt-PA thrombolysis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
- •Aged ≥18 and ≤74 years
- •A baseline NIHSS score between 4 to 25
- •Intravenous rt-PA thrombolysis conducted within 4.5 hours after stroke onset, if known, or the time last seen well [termed "time last known at neurologic baseline" (TLK@B)]
- •The time to the start of administration of Study Drug must be ≤10 h after time of symptom onset or TLK@B
- •Informed consent was signed by the subject or the legal representative
排除标准
- •Prior to stroke, significant disability exists, with modified Rankin Scale >1 point
- •With medical history or evidence of cerebral hemorrhage, subarachnoid hemorrhage, arteriovenous malformation, cerebral aneurysm or brain tumor
- •With clinical or imaging evidence of contralateral cerebral infarction which is believed to have influence on the patient outcome by the investigators
- •With clinical or imaging evidence of occlusion in vertebral or basilar artery
- •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
- •With gastrointestinal bleeding and instable hemodynamics or other causes that force the patient to stop nutritional support
- •Renal disorder from the patient's history (e.g., dialysis) or eGFR of <60 mL/min/1.73 m2
- •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 >2 times upper limit of normal)
- •Blood glucose <3.0 mmol/L at enrollment or immediately prior to administration of Study Drug, or a clinically significant history of hypoglycemia
- •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
- •Known sulfonylurea treatment within 7 days. Sulfonylureas include glyburide/glibenclamide; glibenclamide plus metformin; Xiaoke Pill (a Chinese patent medicine with main effective constituent of glibenclamide); glimepiride; repaglinide; nateglinide; glipizide; gliclazide; tolbutamide; glibornuride
- •Known treatment with bosentan within 7 days
- •Known allergy to sulfa or specific allergy to sulfonylurea drugs
- •Known G6PD enzyme deficiency
- •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
- •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
- •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
- •Patients currently receiving an investigational drug
- •Mentally incompetent (prior to qualifying stroke) patients and wards of the state
- •Patients who, in the opinion of the investigator, are not suitable for the study (reason to be documented)
研究组 & 干预措施
Glibenclamide
Active Comparator
Glibenclamide Tablets
干预措施: Glibenclamide (Drug)
Placebo
Placebo Comparator
Placebo for Glibenclamide
干预措施: Placebo (Drug)
结局指标
主要结局
Functional outcome: The proportion of mordified Rankin Scale of 0 to 2 points
时间窗: 90 days after the stroke onset
The proportion of mordified Rankin Scale of 0 to 2 points at 90 days
次要结局
- Early improvement: The proportion of NIHSS decreased ≥ 4 points(7 days after the stroke onset)
- Hemorrhagic transformation: The proportion of parenchymal hemorrhagic transformation in cranial CT(96 hours after the stroke onset)
- Midline shift: The proportion of midline shift ≥ 6 mm in cranial CT(96 hours after the stroke onset)
- Functional outcome 2: The modified Rankin Scale distribution(90 days after the stroke onset)
- Functional outcome 3: The proportion of Barthel Index of 60-100 points(90 days after the stroke onset)
- Functional outcome 4: The proportion of IQCODE of ≤ 3.40(6 months and 1 year after the stroke onset)
- Blood-brain barrier: The serum concentration of MMP-9(Baseline, 24, 48, and 72 hours after the stroke onset)
研究者
研究点 (8)
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