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Clopidogrel of loading dosage to treat acute ischaemic stroke in China (CLASS-CHINA)

Clopidogrel of loading dosage to treat acute ischaemic stroke in China (CLASS-CHINA): A randomized double-blind parallel controlled clinical trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN07057952
Enrollment
600
Registered
2008-03-14
Start date
2008-02-28
Completion date
Unknown
Last updated
2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute ischaemic stroke Circulatory System Acute ischaemic stroke

Interventions

Two arms: 1 Loading dose (LD) group: patients will receive a 300 mg loading dose of clopidogrel right after randomization, followed by daily 75 mg clopidogrel for the next 27 days (total 28 days) 2

Sponsors

Jinan University Guangzhou (China)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

MeasureTime frame
Stroke recurrence or SIP (evaluated by the National Institutes of Health Stroke Scale [NIHSS]) within 7days.

Secondary

MeasureTime frame
1. Death or dependence (modified Rankin Scale [mRS] >=3) at 28 and 90 days 2. Death or stroke recurrence within 28 days 3. Stroke recurrence, acute myocardial infarction or vascular death with 28 days 4. Bleeding: Life-threatening bleeding, major bleeding and minor bleeding

Countries

China

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026