NCT02776540已完成4 期
Clopidogrel Loading for Acute Ischaemia of Recent Onset (CAIRO)
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 188
- 试验地点
- 1
- 主要终点
- The change of NIH stroke scale score
研究概览
简要总结
Evaluate the role of loading Clopidogrel in acute ischemic stroke in improving neurological outcome of stroke in cases patients will be non-eligible for, or declined, treatment with or intravenous thrombolysis with rTPA, rTPA is not available or thrombectomy.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •First ever presentation with acute ischemic stroke. Previous transient ischemic attacks (TIA's) are not excluding, regardless of their frequency or severity
- •Ictus to drug time does not to exceed 9 hours (allowing for at least 30 minutes to obtain imaging)
- •Patients with undetermined time of onset will be included only if they were last seen well within the same time window (9hrs). Onset of events in patients presented with stuttering stroke will be considered from the onset of the first clinical manifestation.
- •According to National Institute of Health Stroke Scale (NIHSS) on admission, patient will be recruited with NIHSS between 4 and 24 (both inclusive).
排除标准
- •Patients eligible for intravenous (recombinant tissue plasminogen activator) rTPA thrombolysis or thrombectomy.
- •If NIHSS on admission is 3 or less, 25 or more, or patients who are showing rapidly resolving symptoms prior to the results of imaging.
- •Clinical seizures at the onset of stroke.
- •Patients with known history or manifestations of any major organ failure.
- •Patients who have had acute myocardial infarction within 1 month; and/or with management interfering with the current study (e.g. warfarin).
- •Patients with active malignancies, and/or have been on chemo- or radiotherapy within the last year.
- •Patients with active peptic ulcer and/or (gastrointestinal tract) GIT surgery or bleeding within the last year.
- •Persistent uncontrolled vomiting during the first day of admission.
- •Patients with major surgery within the last 3 months.
- •Patients with history of uncontrolled bleeding site, within the prior year.
- •Patients with known allergy to study drugs.
- •Patients with known history of persistent or recurrent (central nervous system) CNS pathology (e.g. epilepsies, meningioma, multiple sclerosis).
- •Patients with past history of head trauma with residual neurological deficit
- •Patients who are on regular Clopidogrel during the week before admission.
- •Patient with raised prothrombin time (PT) on admission, either on anticoagulants (with raised INR>1.3, PT >18 second) or not (PT> 15 second), or on drugs that might increase possibility of peripheral bleeding (e.g. corticosteroids).
- •Patients who have an indication for full anti-coagulation during the first week of their hospital stay will be retrospectively excluded.
- •Patients receiving anti-coagulants in deep venous thrombosis (DVT) prophylaxis doses will NOT be excluded:
- •Enoxaparin 40mg/d (or equivalent).
- •Heparin with partial thromboplastin time (PTT) not exceeding 50 seconds.
- •Oral anticoagulation with INR <1.
- •Pregnancy or breast feeding
- •Stroke due to venous thrombosis
- •Hemorrhagic stroke
- •Blood pressure < 90/60 or > 185/110 mmHg, if not responding to intravenous antihypertensive therapy or requiring aggressive treatment to reduce it below this limit
- •Arterial puncture in a non-compressible site within the previous week
- •Strokes following cardiac arrest or profuse hypotension.
- •Blood glucose level < 50 or > 400 mg/dl on admission
- •CBC with picture of severe anemia (Haematocrit <0.25), thrombocytopenia (Platelets < 100,000) or leucopenia (WBC < 3,000).
- •Significant electrolyte imbalance that may account for the presenting manifestations
- •Contraindications to imaging
- •Urgent brain CT revealing any of the following:
- •Hemorrhage.
- •Major cerebral non-vascular pathology.
- •Suspected arterio-venous malformation (AVM).
- •Previous intracerebral hemorrhage or old infarctions larger than 1.5 cm.
- •Massive acute hypo density in the brain region corresponding to the current symptoms.
研究组 & 干预措施
900 mg Clopidogrel
Active Comparator
67 patients will receive 12 tablets clopidogrel ( each 75 mg) as total 900 mg each patient
干预措施: Clopidogrel (Drug)
600 mg Clopidogrel
Active Comparator
67 patient will receive 8 tablets clopidogrel (each 75 mg) as total 600 mg each patient and 4 tablets placebo to receive 12 tablets as total
干预措施: Clopidogrel (Drug)
400 mg Aspirin
Placebo Comparator
67 patients will receive 4 tablets Aspirin ( each 75 mg) as total 300 mg for each patient and 8 tablets placebo to receive 12 tablets as total
干预措施: Aspirin (Drug)
结局指标
主要结局
The change of NIH stroke scale score
时间窗: Baseline and up to 1 week
Patients will be assessed for early neurologic improvement or deterioration using the change of NIH stroke scale score. Early neurological outcome
Neurologic outcome
时间窗: 3 months
patients will be assessed for neurologic outcome using the Modified Ranking Scale at 3 months after onset
次要结局
- Bleeding complications of loading clopidogrel(1 week)
研究者
Eman Mones Abushady
Assistant Lecturer of Neurology
Ain Shams University
研究点 (1)
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