Revacept in Symptomatic Carotid Stenosis (Revacept/CS/02) "Revacept/CS/02"


Phase 2 Results N/A

Eligibility Criteria

Inclusion Criteria

1. Signed written informed consent
2. Target population
- Diagnosis:
- 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
- Age and sex: Men and women aged > 18 years Women of childbearing potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study and for up to 4 weeks after receiving investigational product in such a manner that the risk of pregnancy is minimised.

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)