Revacept in Symptomatic Carotid Stenosis

Exclusion Criteria

• •1. Sex and reproductive Status:
• •* WOCBP who are unwilling or unable to use an acceptable method to avoid pregnancy for up to 4 weeks after receiving investigational product.
• •* Women who are pregnant or breastfeeding
• •* Women with a positive pregnancy test on enrollment or prior to investigational product administration.
• •2. Target disease exceptions
• •* 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)
• •3. 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/ul), bleeding diathesis or coagulopathy (pathological international normalised ratio (INR) or activated partial thromboplastin 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 umol/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)