Prevention of one sort of cerebral vascular stroke (small subcortical strokes) in patients who already suffered one before

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 2500

Inclusion Criteria

One of the following lacunar stroke clinical syndromes (adapted from Fisher) lasting > 24 hrs: a. Pure motor hemiparesis (PMH) b. Pure sensory stroke c. Sensorimotor stroke d. Ataxic hemiparesis e. Dysarthria-clumsy hand syndrome f. Hemiballism g. PMH with facial sparing h. PMH with horizontal gaze palsy i. PMH with contralateral III palsy j. PMH with contralateral VI palsy k. Cerebellar ataxia with contralateral III palsy l. Pure dysarthria 2. Absence of signs or symptoms of cortical dysfunction such as aphasia, apraxia, agnosia, agraphia, homonymous visual field defect, etc. 3. No ipsilateral cervical carotid stenosis (?50%) by a reliable imaging modality done in an approved laboratory within 6 months of the qualifying S3, if hemispheric. 4. 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. Major risk sourcesa: Minor risk sourcesc: ? Atrial fibrillation ? Mitral valve prolapse + myxomatous changes ? Mitral stenosis ? Mitral annular calcification ? Prosthetic cardiac valves ? Patent foramen ovaled ? Recent (< 3 mos transmural MI) ? Atrial septal aneurysm ? LV thrombus, especially if mobile or protruding ? LV wall abnormalities (without thrombus) ? Atrial myxomas ? Calcific aortic stenosis ? Infective endocarditis ? Non-ischemic dilating cardiomyopathiesb ? Marantic endocarditis aAssociated with a substantial absolute risk of stroke, firmly linked to an embolic mechanism bRisk varies with the type and severity cAssociated with a low or uncertain absolute risk of initial or recurrent stroke or are incompletely established as direct embolic source dIf associated with pulmonary hypertension with sustained right-to-left shunting and venous source of emboli, it is a major risk.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 100
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 50

Exclusion Criteria

Disabling stroke (Modified Rankin Scale ?4) 2. Previous intracranial hemorrhage (excluding traumatic) or hemorrhagic stroke 3. Age under 40 years 4. High risk of bleeding (e.g. recurrent GI or GU bleeding, active peptic ulcer disease, etc) 5. Anticipated requirement for long-term use of anticoagulants (e.g. recurrent DVT) or other antiplatelets 6. Prior cortical stroke (diagnosed either clinically or by neuroimaging), or prior cortical or retinal TIA 7. Prior ipsilateral carotid endarterectomy 8. Impaired renal function: characterized by estimated GFR < 40 9. Intolerance or contraindications to aspirin or clopidogrel (including thrombocytopenia, prolonged INR) 10. A score < 24 (adjusted for age and education; adapted from Crum et al, 1993; n = 18,056)