Secondary Prevention of Small Subcortical Strokes Trial

Inclusion Criteria

• •INCLUSION:
• •Small subcortical ischemic stroke or subcortical TIA.
• •One of the lacunar stroke clinical syndromes (adapted from Fisher) lasting \> 24 hrs within the past 6 months
• •Absence of signs or symptoms of cortical dysfunction such as aphasia, apraxia, agnosia, agraphia, homonymous visual field defect, etc.
• •No ipsilateral cervical carotid stenosis (≥50%) by a reliable imaging modality done in an approved laboratory since the qualifying small subcortical stroke (S3), if hemispheric.
• •No major-risk cardioembolic sources requiring anticoagulation or other specific therapy. Minor-risk cardioembolic sources will be permitted if anticoagulation is not prescribed by the patient's primary care physician.
• •Subcortical TIA with corresponding lesion on DWI.
• •MRI evidence of S3: a. Presence of an S3 (1.5 and 2 cm in diameter corresponding to the qualifying event on DWI; when TIA, ADC image must confirm lesion or T2/FLAIR (hyperintense lesions) (required for all brainstem events) OR multiple S3s on FLAIR/TI(\<1.5 cm in diameter) (hypointense lesions) b. Absence of cortical stroke and large subcortical stroke (recent or remote).
• •EXCLUSION:
• •To be eligible for entry into the study, the patient must not meet any of the criteria listed below:
• •Disabling stroke (Modified Rankin Scale less than or equal to 4)
• •Previous intracranial hemorrhage (excluding traumatic) or hemorrhagic stroke
• •Age under 30 years
• •High risk of bleeding (e.g. recurrent GI or GU bleeding, active peptic ulcer disease, etc)
• •Anticipated requirement for long-term use of anticoagulants (e.g. recurrent DVT) or other antiplatelets
• •Prior cortical stroke (diagnosed either clinically or by neuroimaging), or prior cortical or retinal TIA
• •Prior ipsilateral carotid endarterectomy
• •Impaired renal function: GFR \<40
• •Intolerance or contraindications to aspirin or clopidogrel (including thrombocytopenia, prolonged INR)
• •A score \< 24 (adjusted for age and education) on the Folstein Mini Mental Status Examination
• •Medical contraindication to MRI
• •Pregnancy or women of child-bearing potential who are not following an effective method of contraception
• •Geographic or social factors making study participation impractical
• •Unable or unwilling to provide informed consent
• •Unlikely to be compliant with therapy/unwilling to return for frequent clinic visits
• •Patients concurrently participating in another study with an investigational drug or device
• •Other likely specific cause of stroke (e.g. dissection, vasculitis, prothrombotic diathesis, drug abuse)