Levels of Inflammatory Markers in the Treatment of Strokeā€”An SPS3 Ancillary Study "LIMITS"


Phase N/A Results N/A

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)