EUCTR2021-002219-69-FR招募中1 期
ong-term iron chelation in the prevention of secondary degeneration after cerebral infarction
CHU de Bordeaux0 个研究点目标入组 100 人开始时间: 2021年5月28日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 100
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •- Patient older than 18 years old.
- •- Covered by a social insurance
- •- With a stroke involving the deep territory of the middle cerebral artery (including at least half of the volume of the striatum) due to occlusion of the carotid artery or of proximal M1 or M2 segments. The artery can be occluded when the patient is admitted at the acute phase or already recanalized as soon as the striatum is involved.
- •- Absolute neutrophil count =1.5 x109/L.
- •- For women of childbearing potential, negative ß HCG test and effective contraception.
- •- Written informed consent dated and signed prior to the beginning of any procedures related to the clinical trial. Patients unable to give their personal consent (severe aphasia, impaired understanding or attention induced by the infarction) may be included with the consent by a trusted person provided in article L. 1111-6, by the family or by a person who has a close and stable relationship with the person concerned. The person concerned is informed as soon as possible and his consent is sought during visit at 3 month or 6 month if he regains his capacity to consent. These patients may be included because the treatment may be provided by the caregiver, or a home nurse for patients alone or for whom the caregiver is unable to follow the treatment. Most severe patients, in rehabilitation structure will have support for taking treatment and monitoring it
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 100
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 100
排除标准
- •- Contraindication to MRI.
- •- Pregnant or breast feeding women.
- •- Inability to swallow correctly (required for oral treatment).
- •- History of symptomatic cerebral infarct or hemorrhage.
- •- Pre-stroke modified Rankin Scale [mRS] score>2).
- •- History of severe cognitive impairment (dementia).
- •- History of recent (within the past 6 months) and evolving psychiatric disorders matching to axis 1 of the DSM-IV criteria.
- •- History of stroke directly involving substantia nigra or thalamus.
- •- Microbleed, or past hematoma involving substantia nigra; past hematoma involving thalamus.
- •- PH1 or PH2 hemorrhagic transformation.
- •- Hypersensitivity to Deferiprone or any of the excipients.
- •- Patients with agranulocytosis or with a history of agranulocytosis.
- •- Patients with history of relapsing neutropenia.
- •- Patient with immunosuppression condition.
- •- Due to the risk of agranulocytosis caused by Deferiprone and the unknown mechanism by which this agranulocytosis is induced, combining Deferiprone with other medicinal products known to cause agranulocytosis will not be allowed. Such medicinal products include clozapine as well as some NSAIDs (e.g. Phenylbutazone or Metamizole), antithyroid agents, sulfonamide antibiotics or metothrexate.
- •- Patients with anaemia (regardless of latter aetiology) or a history of another haematological disease.
- •- Participation in another drug study (Investigational medical product) within 1 month prior to inclusion in the study and within 1 month after the final evaluation.
- •- Kidney or liver failure.
- •- Patient in an emergency situation
- •- Patient under permanent guardianship.
- •- Patient subject to a safeguard measure of justice.
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