Secondary Prevention of Small Subcortical Strokes Trial "SPS3"

Completed

Phase 3 Results N/A

Eligibility Criteria

INCLUSION:
Small subcortical ischemic stroke or subcortical TIA.
Inclusion criteria are based on TOAST criteria supplemented by required MRI data. All of the following criteria must be met:
- 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)