Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 5:18 PM
Ignite Modification Date:
2025-12-26 @ 5:18 PM
NCT ID:
NCT01645306
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)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01645306
Study Brief:
Protocol Section:
NCT01645306