2024-517606-29-00招募中3 期
TENECTEPLASE IN CENTRAL RETINAL ARTERY OCCLUSION STUDY (TenCRAOS): A Prospective, randomised-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 randomisation)
Oslo University Hospital HF18 个研究点 分布在 6 个国家目标入组 76 人开始时间: 2024年10月31日最近更新:
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 76
- 试验地点
- 18
- 主要终点
- Primary endpoint: Proportion of patients with ≤ 0.7 logMAR best-corrected visual acuity in the affected eye at 30 (±5) days after treatment, representing an improvement in best-corrected visual acuity of at least 0.3 logMAR (intention-to-treat (ITT) analysis).
研究概览
简要总结
To assess the effect of systemic tenecteplase within 4.5 hours of onset of CRAO.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Non-arteritic central retinal artery occlusion with ≥ 1.0 logMAR best-corrected visual acuity and symptoms lasting less than 4.5 hours.
- •Ability to administer the Investigator Medicinal Product (IMP) within 4.5 hours of symptom onset.
- •Age ≥18 years.
- •Informed written consent of the patient.
- •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.
排除标准
- •Non-arteritic central retinal artery occlusion with ≥ 1.0 logMAR best-corrected visual acuity and symptoms lasting less than 4.5 hours.
- •Ability to administer the Investigator Medicinal Product (IMP) within 4.5 hours of symptom onset.
- •Age ≥18 years.
- •Informed written consent of the patient.
- •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.
- •No other active intervention targeting CRAO.
- •Branch retinal artery occlusion, cilioretinal artery supplying the macula, combined arterial-venous occlusion, proliferative diabetic retinopathy, elevated intraocular pressure (> 30 mmHg) or clinical suspicion of ophthalmic artery occlusion (e.g. choroidal nonperfusion, absence of cherry red spot, no light perception).
- •Systemic diseases; severe general diseases, systemic arterial hypertension (blood pressure >185/110 mmHg (2)), despite medical therapy, or clinical suspicion of acute systemic inflammation.
- •Presence of intracranial haemorrhage on brain MRI/CT.
- •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, hemorrhagic diathesis, aneurysms, inflammatory vascular diseases (eg, giant cell arteritis, granulomatosis with polyangitis), endocarditis, or gastric ulcer.
- •No willingness and ability of the patient to participate in all follow-up examinations.
- •Pregnancy (if suspicion of pregnancy s-hCG or u-hCG must be negative).
- •Allergy or intolerance to any ingredients of IMP (including placebo) or gentamicin or acetylsalicylic acid.
- •Other conditions / circumstances likely to lead to poor treatment adherence (eg, history of poor compliance, alcohol or drug dependency, no fixed abode).
- •Significant bleeding disorder either at present or within the past 6 months.
- •Effective oral anticoagulant treatment, eg, warfarin sodium (INR >1.3).
- •Effective anticoagulant treatment with heparin or low molecular weight heparin the last 48 hours.
- •Any history of central nervous system damage (ie, neoplasm, aneurysm, intracranial or spinal surgery).
- •Known hemorrhagic diathesis.
- •Major surgery, biopsy of a parenchymal organ, or significant trauma within the past 2 months (this includes any trauma associated with acute myocardial infarction).
- •Recent non-compressible vessel puncture within 2 weeks.
- •Recent trauma to the head or cranium.
- •Prolonged cardiopulmonary resuscitation (>2 minutes) within the past 2 weeks.
- •Acute pericarditis and/or subacute bacterial endocarditis.
- •Acute pancreatitis.
- •Severe hepatic dysfunction, including hepatic failure, cirrhosis, portal hypertension (oesophageal varices) and active hepatitis.
- •Active peptic ulceration.
- •Arterial aneurysm and known arterial/venous malformation.
- •Neoplasm with increased bleeding risk.
- •Any known history of hemorrhagic stroke or stroke of unknown origin.
- •Known history of ischemic stroke or transient ischemic attack in the preceding 3 months.
结局指标
主要结局
Primary endpoint: Proportion of patients with ≤ 0.7 logMAR best-corrected visual acuity in the affected eye at 30 (±5) days after treatment, representing an improvement in best-corrected visual acuity of at least 0.3 logMAR (intention-to-treat (ITT) analysis).
Primary endpoint: Proportion of patients with ≤ 0.7 logMAR best-corrected visual acuity in the affected eye at 30 (±5) days after treatment, representing an improvement in best-corrected visual acuity of at least 0.3 logMAR (intention-to-treat (ITT) analysis).
次要结局
未报告次要终点
研究者
CI
Scientific
Oslo University Hospital HF
研究点 (18)
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