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

advanceCOR GmbH0 个研究点目标入组 150 人开始时间: 2011年11月28日最近更新: 2020年9月28日

适应症

试验速览

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•Main inclusion criteria
•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 Carotid Surgery Trial (ECST) criteria
•TIA, amaurosis fugax or stroke within the last 30 days
•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 50
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 100

•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)
•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 anti-platelet therapy with aspirin or clopidogrel and other P2Y inhibitors at screening (3 days for dipyridamole extended release; 8 hours for tirofiban/Aggrastat)
•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 present)

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