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Trial Detail

CUHK_CCT00164

2008-07-09

Retrospective

NIL

CUHK Neurology Fund

Division of Neurology, Department of Medicine & Therapeutics, CUHK

N/A

Ka Sing Wong

Department of Medicine & Therapeutics, The Chinese University of Hong Kong

Tel: 852-26323144; fax: 852-26493761

email: ks-wong@cuhk.edu.hk;

The Chinese University of Hong Kong

Ka Sing Wong

Department of Medicine & Therapeutics, The Chinese University of Hong Kong

Tel: 852-26323144; fax: 852-26493761

email: ks-wong@cuhk.edu.hk;

The Chinese University of Hong Kong

Clopidogrel plus Aspirin for Infarct Reduction in acute stroke/TIA patients with large artery stenosis and microembolic signal

Clopidogrel plus Aspirin for Infarct Reduction in acute stroke/TIA patients with large artery stenosis and microembolic signal

CLAIR

China, Singapore, Thailand, Malaysia

Yes

2003-05-29

stroke or transient ischemic attack(TIA)

Drug

antiplatelet drugs: clopidogrel and aspirin.

7 days

This is a multi-centre, randomised, controlled trial with subjects randomly assigned to receiving either 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.

Key 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.

Key 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.

18

no

Both Male and Female

Interventional

Randomized

Active

Single-blind

Parallel

2003-11-25

100

Complete

Proportion of patients with at least one microembolic signal in the Clopidogrel + Aspirin group compared with the Aspirin alone group at Day 2.

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.

No

2009-11-28

ChiCTR-TRC-09000723

2010-05-04

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