Patients suffering from symptomatic carotid artery stenosis, transient ischemic attacks, amaurosis fugax or stroke and who presenting with microembolic signals. MedDRA version: 20.0 Level: PT Classification code 10007687 Term: Carotid artery stenosis System Organ Class: 10029205 - Nervous system disorders
Conditions
Sponsors
advanceCOR GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: • 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 (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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Efficacy objectives are: • Assessment of incidence of microembolic signals (MES) by transcranial Doppler (TCD) examination (before and after treatment) • Rate of MES per hour (before and after treatment) • Cerebral lesion analysis by DWI-NMR • Assessment of neurological status (NIH Stroke Scale) • Clinical endpoints will be summarised cumulatively i.e. before treatment, after treatment, at 3 months and at 12 months. The following endpoints will be recorded: o Rate of all cause death o Rate of stroke-related death o Any TIA, amaurosis fugax or stroke including haemorrhagic stroke • Assessment of cardiovascular outcome including myocardial infarction and re-intervention up to 3 and 12 months ;Secondary Objective: Not applicable;Primary end point(s): Exploratory endpoints are: • Assessment of incidence of microembolic signals (MES) by transcranial Doppler (TCD) examination (before and after treatment) • Rate of MES per hour (before and after treatment) • Cerebral lesion analysis by DWI-NMR • Assessment of neurological status (NIH Stroke Scale) • Clinical endpoints will be summarised cumulatively i.e. before treatment, after treatment, at 3 months and at 12 months. The following endpoints will be recorded: o Rate of all cause death o Rate of stroke-related death o Any TIA, amaurosis fugax or stroke including haemorrhagic stroke • Assessment of cardiovascular outcome including myocardial infarction and re-intervention up to 3 and 12 months ;Timepoint(s) of evaluation of this end point: Baseline to 1-2 days after treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): •Rate of MES per hour (before and after treatment) •Assessment of neurological status (NIH Stroke Scale) •Cerebral lesion analysis by DWI-NMR and correlation to neurological status (before and after treatment) •Clinical endpoints will be summarised cumulatively i.e. before treatment, 1 and 3 days after treatment, at 3 months and at 12 months. The following endpoints will be recorded: oRate of all cause death oRate of stroke-related death oAny TIA, amaurosis fugax or stroke including haemorrhagic stroke •Assessment of cardiovascular outcome including myocardial infarction and re-intervention up to 3 and 12 months ;Timepoint(s) of evaluation of this end point: Baseline to 3 months / 12 months. | — |
Countries
Germany, United Kingdom
Contacts
Public ContactProf. Dr. med. Götz Münch
advanceCOR GmbH
Outcome results
None listed