Secondary prevention of small subcortical strokes MedDRA version: 15.0 Level: LLT Classification code 10063751 Term: Ministroke System Organ Class: 10029205 - Nervous system disorders
Conditions
Interventions
Trade Name: PLAVIX 75 mg comprimidos recubiertos con película
Pharmaceutical Form: Coated tablet
INN or Proposed INN: CLOPIDOGREL
Other descriptive name: CLOPIDOGREL
Concentration unit: mg milligram(s
Sponsors
National Institutes of Neurological Disorders: Stroke
Eligibility
Sex/Gender
All
Inclusion 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 (=65 years) yes F.1.3.1 Number of subjects for this age range 50
Exclusion criteria
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine whether combination antiplatelet therapy consisting of aspirin (325 mg/d, enteric coated) plus clopidogrel (75 mg/d) is superior to aspirin (325 mg/d, enteric coated) for reducing recurrent stroke (the primary endpoint), cognitive decline and major vascular events.;Secondary Objective: To determine whether ?intensive? blood pressure lowering to a specific target range is superior to ?usual? hypertension management for reducing recurrent stroke, cognitive decline and major vascular events.;Primary end point(s): First occurrence during follow-up of any stroke, including ischemic and hemorrhagic;Timepoint(s) of evaluation of this end point: length of follow-up | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: length of follow-up;Secondary end point(s): The impact of antiplatelet therapy on the rate of cognitive decline. The null hypothesis is that there will be no difference in the rate of cognitive decline among SPS3 participants assigned to receive aspirin alone vs. the combination of aspirin with clopidogrel. Analysis for the effects of therapy on cognitive function will be through assessing changes on repeated neuropsychological tests. The primary measure of cognitive function will be the Cognitive Assessment Screening Instrument. | — |
Countries
Argentina, Ecuador, Spain, United States
Contacts
Public ContactFundación IDIBELL
IDIBELL
Outcome results
None listed