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 @ 12:37 PM
Ignite Modification Date:
2025-12-24 @ 12:37 PM
NCT ID:
NCT00046761
Eligibility Criteria:
Inclusion Criteria:
* Patient must have a clinical diagnosis of acute cortical ischemic stroke.
* Patient must be randomized into the study within six hours after the initial onset of stroke symptoms.
* Patient must have a measurable focal neurological deficit for a minimum duration of 60 minutes.
* Patient must have a CT or MRI examination compatible with the clinical diagnosis of acute ischemic stroke.
* Patient must have had a pre-stroke mRS scale score of 0 or 1.
* Other inclusion criteria as specified in the study protocol.
Exclusion Criteria:
* Patient must not have a body weight of more than 125 kg.
* Patient must not have a CT and/or MRI with evidence of a non-ischemic mechanism, subarachnoid hemorrhage, or primary intracerebral and/or intraventricular hemorrhage.
* Patient must not have all three of the following findings:
1. reduced level of consciousness (has score of greater than or equal to two on NIHSS Question 1a)
2. forced eye deviation or total gaze paresis (has score of 2 on NIHSS Question 2) and
3. dense hemiplegia (no movement) of upper and lower extremities (i.e., has score of 4 on NIHSS Question 5 regarding motor arm and has score of 4 on NIHSS Question 6 regarding motor leg).
* Patient must not have neurological signs and symptoms that are rapidly improving.
* Patient must not have a severe coexisting or terminal systemic disease.
* Patient must not be pregnant or lactating.
* Patient must not have impaired hepatic function; bilirubin greater than 2 mg/dL and or ascites.
* Patient must not have impaired renal function; serum creatinine greater than 2 mg/dL.
* Patient must not have congestive heart failure.
* Patient must not have a baseline ECG showing a PR interval greater than 200 milliseconds, or a corrected QT interval of greater than 480 milliseconds, or a history of ventricular arrhythmias, or a Mobitz Type 1 or greater AV block.
* Patient must not have other exclusion criteria as specified in the study protocol.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00046761
Study Brief:
Protocol Section:
NCT00046761