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 @ 5:19 PM
Ignite Modification Date:
2025-12-26 @ 5:19 PM
NCT ID:
NCT03469206
Eligibility Criteria:
Inclusion Criteria:
* a clinical diagnosis of acute ischemic stroke,
* caused by a large vessel occlusion of the anterior circulation (distal intracranial carotid artery or middle M1/proximal M2) cerebral artery confirmed by CTA,
* CT or MRI ruling out intracranial hemorrhage,
* eligible for IVT and IAT (within 4.5 hours after symptom onset),
* a score of at least 2 on the NIH Stroke Scale,
* age of 18 years or older,
* written informed consent.
Exclusion Criteria:
* \- Pre-stroke disability which interferes with the assessment of functional outcome at 90 days, i.e. mRS \>2
* Any contra-indication for IVT, according to guidelines of the American Heart Association, i.e.:
* arterial blood pressure exceeding 185/110 mmHg
* blood glucose less than 2.7 or over 22.2 mmol/L
* cerebral infarction in the previous 6 weeks with residual neurological deficit or signs of recent infarction on neuro-imaging
* serious head trauma in the previous 3 months
* major surgery or serious trauma in the previous 2 weeks
* gastrointestinal or urinary tract hemorrhage in the previous 3 weeks
* previous intracerebral hemorrhage
* use of anticoagulant with INR exceeding 1.7
* known thrombocyte count less than 100 x 109/L
* treatment with direct thrombin or factor X inhibitors
* treatment with heparin (APTT exceeds the upper limit of normal value) in the previous 48 hours.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03469206
Study Brief:
Protocol Section:
NCT03469206