Secondary Prevention of Small Subcortical Strokes - SPS3

ational Institutes of Neurological Disorders: Stroke0 sites2,500 target enrollmentSeptember 11, 2012

DrugsPLAVIX 75 mg comprimidos recubiertos con película AAs 325

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Not specified
Sponsor: ational Institutes of Neurological Disorders: Stroke
Enrollment: 2500
Status: Active, not recruiting
Last Updated: 13 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

September 11, 2012

End Date

TBD

Last Updated

13 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

ational Institutes of Neurological Disorders: Stroke

Eligibility Criteria

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\)