EUCTR2020-001982-36-CZ进行中（未招募）1 期
Alteplase compared to tenecteplase in patients with acute ischemic stroke: Registry-based pragmatic randomized controlled trial - AcT
Fakultní nemocnice u sv. Anny0 个研究点目标入组 500 人开始时间: 2020年7月17日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 500
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Clinical diagnosis of ischemic stroke (iCMP) with sudden and clear neurological deficit.
- •Onset of iCMP symptoms within the last 4.5 hours, with the exception of acute basilar artery occlusion, where IVT administration is accepted even after 4.5 hours from the onset of symptoms.
- •Age =18 years.
- •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 250
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 250
排除标准
- •Known hypersensitivity to the drug or to any of the excipients.
- •Demonstration of intracranial haemorrhage on CT or MR.
- •Demonstration of a brain disease other than ischemia as a cause of acute neurological deficit.
- •Presence of clear hypodense changes corresponding to acute cerebral ischemia in more than 1/3 of the cerebral media artery basin (ACM) on CT of the brain.
- •Suspected subarachnoid haemorrhage or clinical signs suggestive of subarachnoid haemorrhage, even if a negative CT scan is performed.
- •Acute internal bleeding.
- •Uncontrollable systolic blood pressure above 185 mm Hg or diastolic blood pressure above 110 mm Hg. Uncontrollable BP is considered to be a condition in which, despite adequate antihypertensive treatment, it is not possible to maintain BP values <185/110 mm Hg before the onset of IVT. Single, bolus administration of antihypertensives and subsequent continuous administration are not a contraindication to IVT if the BP is <185/110 mm Hg at the time of IVT initiation.
- •Ischemic CMP or craniocerebral or spinal injuries in the last 3 months in patients with severe residual clinical or radiological findings.
- •Intracranial haemorrhage in the last 6 months.
- •Manifest or severe or dangerous bleeding in the last 21 days, including bleeding into the gastrointestinal or urogenital tract.
- •Known haemorrhagic diathesis.
- •Known arteriovenous malformation or known arterial aneurysm.
- •Intracranial or intraspinal surgery in the last 4 weeks.
- •Arterial puncture at an uncompressible site in the last 7 days.
- •Pregnancy
- •Childbirth in the last 10 days or the third trimester with iminent childbirth.
- •Other known serious conditions with a high risk of severe or life-threatening bleeding.
- •Glycaemia less than 2.7 mmol/l.
- •INR> 1.7. It also applies to patients taking coumarin anticoagulants. Patients taking warfarin do not have an increased risk of symptomatic intracranial haemorrhage if the INR is below 1.7. Warfarin use is an absolute contraindication to IVT if the INR is above 1.7.
- •Platelet count below 100,000/µl; in patients without known thrombocytopenia, it is possible to initiate IVT without knowing the platelet count if their determination and evaluation would lead to a delay in the initiation of IVT; if a platelet count is found below 100,000/µl, IVT must be stopped immediately.
- •Heparin or low molecular weight heparin (LMWH) therapy in the last 48 hours and with an increased aPTT above the upper limit of the laboratory.
- •Abnormal specific coagulation tests with apaxiban, rivaroxaban and endoxaban. Abnormal coagulation tests are prolonged thrombin time (TT) or increased value of a specific anti-Xa test according to the laboratory standard
- •Parallel participation in any other trial involving investigational medication or medical devices
研究者
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