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:
2025-12-25 @ 3:38 AM
Ignite Modification Date:
2025-12-25 @ 3:38 AM
NCT ID:
NCT01643902
Eligibility Criteria:
Inclusion Criteria:
* Age greater or equal to 18 years, and lower or equal to 80 years.
* Signs and symptoms of acute ischemic stroke.
* Symptoms present upon awakening.
* Arriving to the Emergency Department within 4.5 hours of awakening. Treatment with IV tPA must be initiated prior to 4.5hours from waking up.
* NIHSS \>3
* A non-contrast head CT without hemorrhage and without hypodensity more than 1/3 of the middle cerebral artery (MCA) territory; or MRI demonstrating no hemorrhage, and with a diffusion-weighted imaging (DWI) lesion no greater than 70 mL and FLAIR without a well defined hyperintense lesion that is more than 1/3 of the MCA territory.
* Pre-morbid modified Rankin score of 0 or 1.
Exclusion Criteria:
* Rapidly improving deficit to an NIHSS less than 3.
* Sustained systolic blood pressure greater than 185 mmHg or diastolic blood pressure greater than 110 mmHg despite treatment.
* Glucose less than 50 mg/dL.
* Stroke or head trauma within last 3 months.
* History of intracranial hemorrhage. Symptoms of subarachnoid hemorrhage.
* Major surgery within 14 days.
* Gastrointestinal (GI)/Genito-urinary (GU) hemorrhage within 21 days.
* International normalized ratio (INR) \> 1.7.
* Heparin within 48 hours with an elevated activated partial thromboplastin time (aPTT).
* Platelet count less than 100,000.
* Presumed septic embolus or suspicion of bacterial endocarditis.
* Suspicion of aortic dissection.
* Use of anticoagulants such as dabigatran, rivaroxaban, apixaban, enoxaparin.
* Pregnant or lactating women.
* Known allergy or sensitivity to tPA.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT01643902
Study Brief:
Protocol Section:
NCT01643902