EUCTR2011-001006-10-GB进行中（未招募）1 期
REVACEPT, AN INHIBITOR OF PLATELET ADHESION IN SYMPTOMATIC CAROTID STENOSIS: A PHASE II, MULTICENTRE; RANDOMISED, DOSE-FINDING, DOUBLE-BLIND AND PLACEBO-CONTROLLED SUPERIORITY STUDY WITH PARALLEL GROUPS - Revacept/CS/02
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 150
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
入选标准
- •Male and female patients aged >18 years
- •Extracranial carotid artery stenosis (diagnosed by vascular duplex ultrasound peak flow or angiography)
- •-Lesions with = 50 % stenosis according to the European Carotis Surgery Trial (ECST) criteria
- •MES detected by TCD (= 1 MES per hour)
- •TIA, amaurosis fugax or stroke within the last 30 days
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 50
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 100
排除标准
- •Target disease exception
- •NIHSS score > 18
- •Recent intracerebral haemorrhage by X-ray computed tomography (CT) or nuclear magnetic resonance (NMR)
- •Cardiac cause of embolisation (atrial fibrillation or other cardiac source e.g. artificial heart valves)
- •Medical history and concurrent disease
- •History of hypersensitivity, contraindication or serious adverse reaction to inhibitors of platelet aggregation, hypersensitivity to related drugs (cross-allergy) or to any of the excipients in the study drug
- •History or evidence of thrombocytopenia (<30.000/µl), bleeding diathesis or coagulopathy (pathological international normalised ratio (INR) or activated partial thrompoplastin time (aPTT))
- •Thrombolysis within the last 48 hours
- •Relevant haemorrhagic transformation as determined by CT, NMR or anamnesis
- •Oral anticoagulation or dual antiplatelet therapy (aspirin combined with clopidogrel or other P2Y inhibitors) at screening; dipyridamole extended release within last 3 days; tirofiban/Aggrastat within the last 8 hours
- •Sustained hypertension (systolic BP >179 mmHg or diastolic BP >109 mmHg)
- •History of severe systemic disease such as terminal carcinoma, renal failure (or current creatinine >200 µmol/l), cirrhosis, severe dementia, or psychosis
- •Current severe liver dysfunction (transaminase level greater than 5-fold over upper normal range limit)
- •Active autoimmune disorder such as systemic lupus erythematosus, rheumatoid arthritis, vasculitis or glomerulonephritis
- •Known atrial fibrillation or other clinically significant ECG abnormalities (at presentation)
研究者
相似试验
Withheld
不适用
[Trial of device that is not approved or cleared by the U.S. FDA]NCT06762340[Redacted]
Withheld
不适用
[Trial of device that is not approved or cleared by the U.S. FDA]NCT04945941[Redacted]
Withheld
不适用
[Trial of device that is not approved or cleared by the U.S. FDA]NCT06733259[Redacted]
已完成
不适用
Clinical Investigation (Beta) of a New Developed Prosthetic KneeNCT06748729Össur Iceland ehf11
Withheld
不适用
[Trial of device that is not approved or cleared by the U.S. FDA]NCT06422065[Redacted]