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:
2025-12-24 @ 6:35 PM
Ignite Modification Date:
2025-12-24 @ 6:35 PM
NCT ID:
NCT00044057
Eligibility Criteria:
Inclusion Criteria:
* Patients with acute ischemic stroke who are treated with alteplase within 3 hours of stroke onset (Onset is defined as the time that which the patient was last seen in a normal state, or bedtime for unwitnessed strokes occurring during the night).
* Patients who are able to provide written informed consent or have consent provided by a legally authorized representative.
* Patients who are at least 18 years of age.
* Patients who have a National Institutes of Health Stroke Scale (NIHSS) score of at least 7 but not more than 23 and who are conscious.
* Other criteria as specified in the study protocol
Exclusion Criteria:
* Patients who are not eligible to receive treatment with alteplase (t-PA) due to brain hemorrhage, risk for hemorrhage, or other criteria.
* Patients who have stroke of the brainstem or cerebellum.
* Patients who have renal (kidney) disease or insufficiency.
* Patients who have active epilepsy or convulsions during the current stroke episode.
* Patients who are IV drug users or are inebriated.
* Patients who have a history of drug-related anaphylaxis.
* Patients who have taken sedatives, anticonvulsants, or any medication with sedating effects in the 10 days prior study enrollment.
* Patients who have taken more than 1.3 g of aspirin per day in the 2 days prior to enrollment.
* Patients who have a known vitamin hypersensitivity.
* Other exclusion criteria as specified by the study protocol
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00044057
Study Brief:
Protocol Section:
NCT00044057