Pioglitazone Treatment for Hyperglycemic Acute Ischemic Stroke: Effects on the Stress-Immune Response
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- Neurological Status
研究概览
简要总结
Study objective is to determine whether Pioglitazone (PGZ) can improve clinical outcomes in hyperglycemic acute ischemic stroke (IS). The rationale for the proposed research is to develop an acute intervention that can improve neurological recovery and decrease mortality and morbidity in high-risk diabetic stroke patients.
详细描述
This is a prospective, randomized, double blinded stroke intervention study. Patients presenting with hyperglycemia (blood glucose level = or > than 150mg/dl) and acute stroke symptoms within 12h of onset will be randomized to either treatment with PGZ or placebo. Patients will receive oral drug vs placebo once daily for three consecutive days. Blood samples will be obtained at baseline and during the subsequent three days to collect various biomarkers of the stress-immune response following ischemic stroke. Clinical outcomes (NIH-SS and mRS) will be determined at 3 months. Secondary outcome measures are changes in the various blood biomarkers comparing both study groups.
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
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Stroke Patients ages 21 and over
- •Blood sugar ≥ 150 mg/dl
- •Study drug treatment should be initiated within 12 hours after time of symptom onset, if known, or the time last known normal (if time to symptom onset is unknown)
- •MRI or CT proven ischemic stroke
- •Initial NIH SS of ≥ 2
- •Willing and able to provide consent
排除标准
- •Known hypersensitivity to PGZ.
- •Infection at the time of presentation as defined by body temperature > 38 degrees C , pneumonia evident on chest X-ray, urinary tract infection (positive tests for nitrites, leukocyte esterase, and bacteria on urine analysis), other acute infection per history or current use of antibiotic or antiviral treatment.
- •Active malignancy and / or autoimmune disease requiring treatment.
- •Use of immunomodulatory drugs or chemotherapy.
- •History of stroke or brain injury within the last 90 days prior to presentation.
- •Acute illness within the last 30 days which could have affected the white blood cell count.
- •Known history of clinically significant hypoglycemia.
- •Patients already taking PGZ.
- •Active liver disease (ALT and /or AST 2.5 times the upper limit of normal, total bilirubin > 1.2 mg/dl).
- •Acute decompensated heart failure, and/or admission for an acute coronary syndrome, myocardial infarction (MI), cardiac arrest, coronary artery surgery within the past 3 months and patients with New York Heart association Class III and IV heart failure.
- •History of bladder cancer
- •Pregnant and nursing women.
- •Currently incarcerated patients.
研究组 & 干预措施
Pioglitazone treatment group
oral administration of 45mg Pioglitazone daily for three subsequent days, initiated within 12h of stroke symptom onset
干预措施: Pioglitazone 45 mg (Drug)
Placebo group
Oral administration of placebo daily for three subsequent days, initiated within 12h of stroke symptom onset
干预措施: Placebo oral tablet (Drug)
结局指标
主要结局
Neurological Status
时间窗: 90 days post stroke
NIH-Stroke scale (0-42) to assess neurological function with 0 being no deficits and 42 being the worst score
Degree of Disability or Dependence in the Daily Activities
时间窗: 90 days post stroke
Measured using the modified Rankin Scale (0-6) to assess neurological function with a score of 0 for no neurological deficits and a maximum of 6 for an expired patient
次要结局
- Concentration of Markers of Neutrophil Activation and Function(24 hours, 48 hours, and 90 days post-stroke)
- Concentration of Stress Response Markers Including Cortisol, Norepinephrine and Epinephrine(24 hours, 48 hours, and 90 days poststroke)