EUCTR2018-002546-36-NO进行中（未招募）1 期
TENECTEPLASE IN CENTRAL RETINAL ARTERY OCCLUSION STUDY(TenCRAOS): A PROSPECTIVE, RANDOMIZED-CONTROLLED, DOUBLE-DUMMY, DOUBLE-BLIND PHASE 3 MULTI-CENTRE TRIAL OF TNK 0.25 MG/KG + PLACEBO VS. ASA + PLACEBO (2 ARMS WITH 1:1 BLOCK RANDOMIZATION)
Oslo University Hospital0 个研究点目标入组 78 人开始时间: 2019年6月24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
- 78
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
- •1.Non-arteritic central retinal artery occlusion with = 1.0 logMAR visual acuitiy and symptoms lasting less than 4.5 hours.
- •2.Ability to administer the Investigator Medicinal Product (IMP) within 4.5 hours of symptom onset.
- •3.Age =18 years.
- •4.Informed written consent of the patient.
- •5.A woman of childbearing potential (WOCBP) must confirm that in her opinion, she cannot be pregnant, OR if there is a possibility that she is pregnant, a negative pregnancy test must be confirmed before any IMP is given.
- •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 30
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 48
排除标准
- •1.Branch retinal artery occlusion, cilioretinal artery supplying the macula, combined arterial-venous occlusion, proliferative diabetic retinopathy, or elevated intraocular pressure (> 30 mmHg).
- •2.Systemic diseases; severe general diseases, systemic arterial hypertension (blood pressure >185/110 mmHg), despite medical therapy, or clinical suspicion of acute systemic inflammation.
- •3.Presence of intracranial haemorrhage on brain MRI/CT.
- •4.Medical history: heart attack within the last 6 weeks, intracerebral bleeding or neurosurgical operation within the last 4 weeks, therapy with anticoagulation, allergic reaction to contrast agent, haemorrhagic diathesis, aneurysms, inflammatory vascular diseases (eg, giant cell arteritis, granulomatosis with polyangitis), endocarditis, or gastric ulcer.
- •5.No willingness and ability of the patient to participate in all follow-up examinations.
- •6.Pregnancy (if suspicion of pregnancy s-hCG or u-hCG must be negative).
- •7.Allergy or intolerance to any ingredients of IMP or placebo or gentamicin.
- •8.Other conditions / circumstances likely to lead to poor treatment adherence (eg, history of poor compliance, alcohol or drug dependency, no fixed abode).
- •9.Significant bleeding disorder either at present or within the past 6 months.
- •10.Effective oral anticoagulant treatment, eg, warfarin sodium (INR >1.3).
- •11.Effective anticoagulant treatment with heparin or low molecular weight heparin the last 48 hours.
- •12.Any history of central nervous system damage (ie, neoplasm, aneurysm, intracranial or spinal surgery).
- •13.Known hemorrhagic diathesis.
- •14.Major surgery, biopsy of a parenchymal organ, or significant trauma within the past 2 months (this includes any trauma associated with acute myocardial infarction).
- •15.Recent non-compressible vessel puncture within 2 weeks.
- •16.Recent trauma to the head or cranium.
- •17.Prolonged cardiopulmonary resuscitation (>2 minutes) within the past 2 weeks.
- •18.Acute pericarditis and/or subacute bacterial endocarditis.
- •19.Acute pancreatitis.
- •20.Severe hepatic dysfunction, including hepatic failure, cirrhosis, portal hypertension (oesophageal varices) and active hepatitis.
- •21.Active peptic ulceration.
- •22.Arterial aneurysm and known arterial/venous malformation.
- •23.Neoplasm with increased bleeding risk.
- •24.Any known history of hemorrhagic stroke or stroke of unknown origin.
- •25.Known history of ischemic stroke or transient ischemic attack in the preceding 3 months.
- •26.Dementia.
研究者
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