Cyclosporin A Combined to Intravenous Thrombolysis. Multicenter Randomized Placebo-controlled
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 126
- 试验地点
- 1
- 主要终点
- to determine whether a single injection of CsA after intravenous thrombolysis significantly decreased the volume of cerebral infarction at day 30 ± 15 in the T2-weighted Flair MRI.
研究概览
简要总结
The main objective of this study is to determine whether a single injection of CsA after intravenous thrombolysis can significantly decreased the volume of cerebral infarction at day 30 ± 15 assessed with Flair MRI.
Secondary objectives are to determine whether a single injection of CsA after intravenous thrombolysis is safe and effective regarding to death and disability.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients age ≥ 18 years and <85 years
- •Male or female,
- •Patients with cerebral infarction of less than 4:30H,
- •NIHSS score between 6 and 18
- •Identification of a carotid artery occlusion in the territory in MRI
- •Consent of participation signed by the patient or, if it is unable to give the family or someone you trust if it is present.
- •Patient beneficiary of a social security system.
排除标准
- •Known hypersensitivity to cyclosporin A or castor oil, polyoxyethylene
- •Patient in St. John's wort, stiripentol, bosentan or rosuvastatin
- •History of immunosuppression recent (<6 months): cancer, lymphoma, positive serology for HIV, hepatitis, ...
- •Known hepatic (prothrombin time <50%)
- •Patients treated with sulfonylureas or nicorandil
- •Patients treated with dopamine, adrenaline, noradrenaline or isoprenalin
- •Uncontrolled hypertension defined as systolic blood pressure greater than 185mm Hg and a diastolic pressure above 110 mmHg,
- •Cardiogenic shock defined by systolic blood pressure below 80 mm Hg
- •Contraindication to thrombolysis: History of AIC in the three months history of intracranial hemorrhage, neoplasm, subarachnoid hemorrhage, arteriovenous malformation
- •Presumption of septic embolism or aortic dissection or pericardial effusion.
- •Recent biopsy or surgery within 3 months
- •Head injury less than 3 months
- •Known bleeding diathesis, taking anticoagulants with INR> 1.2
- •Hypoglycemia (blood glucose below 0.5 mmol / l)
- •Known renal, creatinine greater than 130 Mu / L
- •Recent Lumbar puncture <7days
- •Conditions prior psychiatric or neurological deficit does not allow objective analysis of disability
- •History of ischemic stroke or hemorrhagic
- •History of epilepsy and taking antiepileptic
- •Exclusion criteria Imaging
- •Structured hypodensity scanner compatible with recent ischemic stroke
- •Other lesions (tumor or inflammatory cerebral venous thrombosis)
- •The scanner Contraindications: allergy to iodine or major renal creatinine> 130μl or MRI referred to above
- •Women of childbearing age, pregnant or not recognized effective contraception
- •Patients in the measure of legal protection.
研究组 & 干预措施
Ciclosporin A
Injection of 50 mg / ml IV infusion. 5 ml ampoules (250 mg of ciclosporin)
干预措施: Ciclosprin A (Drug)
Placebo
Injectable Saline Solution.
干预措施: Injectable Saline Solution. (Drug)
结局指标
主要结局
to determine whether a single injection of CsA after intravenous thrombolysis significantly decreased the volume of cerebral infarction at day 30 ± 15 in the T2-weighted Flair MRI.
时间窗: at day 30 ± 15 in the T2-weighted Flair MRI.
Volume of cerebral infarction at day 30 ± 15 in the T2-weighted MRI Flair will be measured by manuel contouring by two independent radiologists uninformed of clinical and therapeutic data and therapeutic
次要结局
- to determine whether a single injection of CsA after intravenous thrombolysis, is well tolerated and reduces deaths and disability in patients.(on day 1, J7, J30, J90)