Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCT00164

2 Trial Registration Date

2008-07-09

i Registration Status

Retrospective

3 Secondary IDs

NIL

4 Source(s) of Funding

CUHK Neurology Fund

5 Primary Sponsor

Division of Neurology, Department of Medicine & Therapeutics, CUHK

6 Secondary Sponsor

N/A

Function

Please specify

7 Responsible Contact Person (public contact person for patients interested in participating)

i Name

Ka Sing Wong

ii Address

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

iii Phone

Tel: 852-26323144; fax: 852-26493761

iv Email

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

v Affiliation

vi Country

8 Research Contact Person (person to contact for scientific inquiries)

i Name

Ka Sing Wong

ii Address

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

iii Phone

Tel: 852-26323144; fax: 852-26493761

iv Email

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

v Affiliation

vi Country

9 Official Scientific Title of the Study

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

10 Public Title

i Public Title in Chinese 研究名稱

11 Short Title (Optional)

CLAIR

12 Countries of Recruitment

13 Research Ethic Review

i Has the study received appropriate ethics approval?

Yes

ii When is the approval date?

2003-05-29

iii Full Name of IRB/IEC

Please specify

iv IRB/IEC approval reference number

14 Medical Condition Being Studied

stroke or transient ischemic attack(TIA)

15 Intervention

i Types of intervention

Drug

Please specify

ii Description/ name of Intervention/article

antiplatelet drugs: clopidogrel and aspirin.

iii Dosage form of the intervention

iv Dosage of the intervention

v Duration of the intervention

7 days

vi Frequency of the intervention

16 Comparative Treatments

i Description/ name of comparative treatments

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.

ii Dosage form of the comparative treatments

iii Dosage of the comparative treatments

iv Duration of the comparative treatments

v Frequency of the comparative treatments

17 Key Inclusion and Exclusion Criteria

i Inclusion Criteria

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.

ii Exclusion Criteria

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.

iii Age Minimum

iv Age Maximum

v Gender

18 Study Type

19 Study Design

i Randomization

Randomized

Please specify

ii Nature of control

Active

iii Degree of masking

Single-blind

If Single-blind, who will be masked?

iv Group Assignment

Parallel

v Study Phase

Please specify

vi Study Objectives (Optional)

20 Anticipated trial start date

2003-11-25

21 Target Sample Size

100

22 Recruitment Status

Recruiting

23 Primary Outcome

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

24 Secondary Outcome

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.

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2009-11-28

27 Primary Registry and Trial Identifying Number

28 Date of Registration in Primary Registry

* Legacy Fields

i Recruitment Information Available?

Yes

ii Link to Recruitment Information

NIL

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Trial History Detail on 2009-11-19