stroke or transient ischemic attack(TIA)
Conditions
Interventions
Two groups:clopidogrel daily(300 mg first day and then 75 mg daily) for 7 days or no anti-platelet agent, in additional to aspirin 75-160mg once daily for 7 days.
Sponsors
Division of Neurology, Department of Medicine & Therapeutics, CUHK
Eligibility
Sex/Gender
Male
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. aged 18 or above; 2. subject is diagnosed with stroke or TIA; 3. presence of symptomatic extracranial or intracranial large artery stenosis, with at least one microembolic signal(MES) on a 30 minutes monitoring upstream segment of MCA; 4. subject is presented with symptoms onset within the previous 7 days prior to giving the first dose of trial medication; 5. subject has brain CT performed which excludes intracerebral haemorrhage and brain tumor.
Exclusion criteria
Exclusion criteria: 1. subject has a National Institutes of Health Stroke Scale(NIHSS) of greater than 8, or has a history of intracerebral haemmorrhage, or has known contraindication for the use of clopidogrel or aspirin, including haemorrhagic diathesis; 2. subject is on anticoagulation theraphy(excluding aspirin); 3. subject has sustained hypertension immediately prior to randomisation(systolic > ; 220mmHg or diastolic > 120mmHg); 4. subject has co-existing systemic diseases: terminal carcinoma, renal failure, cirrhosis, severe dementia or psychosis; 5. subject has atrial fibrillation on ECG, chronic rheumatic heart disease, metallic heart valve, thrombocytopenia.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients with at least one microembolic signal in the Clopidogrel + Aspirin group compared with the Aspirin alone group at Day 2.; | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. number of new acute infarct as defined by recent infarct showed on DWI on Day 7 but not on Day 1. 2. number of MES on Day 7 3. number of acute infarct on DWI and number of MES on Day 7 4. NIHSS at Day 7; difference of NIHSS between baseline and Day 7 5. modified Rankin Scale at Day 7(0-2 & 0-1 as "good outcome") 6. overall mortality at Day 7 7. thrombo-embolic events during the study period: recurrent stroke, coronary syndrome, deep vein thrombosis, pulmonary embolus.; | — |
Countries
China
Contacts
Public ContactKa Sing Wong
Outcome results
None listed