Clopidogrel of loading dosage to treat acute ischaemic stroke in China (CLASS-CHINA)
- Conditions
- Acute ischaemic strokeCirculatory System
- Registration Number
- ISRCTN07057952
- Lead Sponsor
- Jinan University Guangzhou (China)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 600
1. Aged 18-80 years
2. Ischemic stroke (IS) within 48 hrs with evidence of computerised tomography (CT) or magnetic resonance imaging (MRI)
3. Satisfying the criteria of partial anterior circulation infarction (PACI) of Oxfordshire Community Stroke Project (OCSP) classification, and large artery atherothrombosis (LAA) of TOAST (the Trial of Org 10172 in Acute Stroke Treatment) classification
4. Informed consent of patient
1. Patients planned for thrombolysis
2. Any of the following:
2.1. Cardiogenic cerebral embolism
2.2. Lacuna cerebral infarction
2.3. Total anterior circulation cerebral infarction
2.4. Posterior circulation cerebral infarction
2.5. Cerebral infarction of the etiology rather than atherothrombosis and unidentified etiology
3. History of allergic reaction to clopidogrel
4. Patients regularly took oral anticoagulants (OAC), heparin or molecular weight heparin (LMWH), thienopyridine (clopidogrel or ticlopidine), aspirin (acetylsalicylic acid) >50 mg/d, Aggrenox® before the onset; or patients who need long-term use of drugs that affect platelet functions
5. History of bleeding disorders; clinically significant or persistent thrompocytopenia or neutropenia.
6. Women who are pregnant or breast-feeding
7. Patients with planned surgery within the next 1 month; with a recent operation or trauma history.
8. Severe systematic disorders i.e. heart, lung, liver, kidney diseases, or malignant tumor; or severe gastrointestinal disorder affecting the absorption of drug
9. Enrolled in other clinical trials within the past 3 months
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Stroke recurrence or SIP (evaluated by the National Institutes of Health Stroke Scale [NIHSS]) within 7days.
- Secondary Outcome Measures
Name Time Method 1. Death or dependence (modified Rankin Scale [mRS] >=3) at 28 and 90 days <br>2. Death or stroke recurrence within 28 days <br>3. Stroke recurrence, acute myocardial infarction or vascular death with 28 days <br>4. Bleeding: Life-threatening bleeding, major bleeding and minor bleeding