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

Suspended

Phase N/A Results N/A

Trial Description

To ensure better protection against the early recurrence or deterioration of ischemic stroke.

Interventions

  • Clopidogrel (Plavix┬«)Drug
    Other Names: Plavix
    Intervention Desc: Antiplatelet agent
  • Placebo Drug
    Intervention Desc: A placebo is a substance or procedure which a patient accepts as a medicine or therapy but which has no specific therapeutic activity for the condition.

Trial Design

Multicenter,randomized double-blind placebo controlled, parallel group study.

Patient Involvement

Patient will be randomized to one of two arms: loading dose group where 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 of 28 days) or routine dose group: patients will receive 75 mg clopidogrel and 3 tablets of placebo right after randomization for the next 27 days (total of 28 days). Both arms will be given basic treatments at the discretion of the responsible doctor, including antihypertension drugs, statins, neuroprotectives, etc. except for aspirin or any other antiplatelet drugs. Chinese herbal products affecting platelet functions cannot be prescribed. During the observational period, if patients experience SIP or recurrence of ischemic stroke, clopidogrel may be stopped, and other antithrombotic therapy, i.e. anticoagulants, or others may be used at the discretion of the responsible doctor. Modified Rankin Scale (mRS) at 28 and 90 days.

Outcomes

Type Measure Time Frame Safety Issue
Primary Stroke recurrence or SIP (evaluated by the NIHSS within 7 days).
Secondary Death or dependence (modified Rankin Scale >=3) at 28 and 90 days; death or stroke recurrence within 28 days; stroke recurrence, acute myocardial infarction or vascular death within 28 days; bleeding: life-threatening bleeding, major bleeding and minor bleeding.

Sponsors

Jinan University Guangzhou (China) The First Affiliated Hospital, Sun Yat-Sen University, Guangzhou (China) Sanofi-Aventis