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 @ 4:02 PM
Ignite Modification Date:
2025-12-26 @ 4:02 PM
NCT ID:
NCT00579306
Eligibility Criteria:
Inclusion Criteria:
* Patient must be randomized within 6 months of qualifying small subcortical stroke (S3) or subcortical TIA
* One of the following lacunar syndromes: PMH; pure sensory stroke; sensorimotor stroke; ataxic hemiparesis; dysarthria; hemiballism; PMH with facial sparing, horizontal gaze palsy, contralateral III palsy, contralateral VI palsy; Ataxia with contralateral III palsy; pure dysarthria
* Absence of cortical dysfunction (aphasia, apraxia, agnosia)
* No ipsilateral cervical carotid stenosis (\>= 50%) if S3 is hemispheric
* No major-risk cardioembolic sources requiring anti-coagulation
* MRI evidence of S3 that is \>=2.0 cm in diameter if DWI/bright lesion on FLAIR/T2 or \<=1.5cm hypointense lesion on FLAIR/T1, corresponding to the qualifying event (required for all brainstem events) OR multiple S3 in cerebral hemispheres of \<=1.5cm hypointense lesions on FLAIR/T1 AND absence of cortical stroke and large subcortical stroke.
Exclusion Criteria:
* Disabling stroke (Ranking Scale \>= 4)
* Prior hemorrhagic stroke
* Age \<30 years
* High risk of bleeding (recurrent GI or GU bleeding, active peptic ulcer disease, etc)
* Need for long-term use of anticoagulants or other antiplatelet agents.
* Prior cortical or retinal stroke / TIA
* Prior ipsilateral carotid endarterectomy if hemispheric S3
* Impaired renal function: GFR\<40 cc/min
* Intolerance/contraindication to aspirin or clopidogrel
* Adjusted Folstein MMSE \<24
* Medical contraindication to MRI
* Pregnancy or child-bearing potential without contraception
* Other specific causes of stroke (e.g. dissection, vasculitis, drug abuse)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
30 Years
Study:
NCT00579306
Study Brief:
Protocol Section:
NCT00579306