Antiplatelet Therapy in Acute Mild-Moderate Ischemic Stroke "ATAMIS"

Recruiting

Phase Early 1 Results N/A

Trial Description

The risk of early recurrence or progression of acute ischemic stroke is very high, even in patients treated with aspirin. The Chance study show that clopidogrel plus aspirin treatment reduced the risk of recurrent stroke in patients with transient ischemic attack (TIA) or minor ischemic stroke (NIHSS ≤ 3) within 24 hour onset and was not associated with increased hemorrhage events, compared with aspirin monotherapy. However, it is not known whether the dual antiplatelet treatment could reduce the risk of early recurrence or progression in patients with acute mild to moderate ischemic stroke (4 ≤ NIHSS ≤ 10). The investigators hypothesise that clopidogrel-aspirin treatment will be superior to aspirin monotherapy in this group of patients.

Detailed Description

The ATAMIS study is a multicentre, prospective, randomised, open-label, controlled trial with a target enrollment of 3,000 patients from 60 centres of the Northeast China. Eligible patients are as follows: (1) definite acute ischemic stroke; (2) neurological deficit: 4 ≤ NIHSS ≤ 10; (3) time from onset to drug treatment: within 48 hours.
Patients in the clopidogrel-aspirin group will receive a 300mg loading dose of clopidogrel, followed by clopidogrel 75 mg/d and aspirin 75 mg/d from day 2 to day 14, and followed by clopidogrel 75 mg/d or aspirin 100 mg/d from day 15 to day 90.
Patients in the aspirin-alone group will receive 100-300 mg aspirin from day 1 to day 14, followed by aspirin 100 mg/d from day 15 to day 90.
The primary efficacy end point is early neurological deterioration assessed as a change of NIHSS: no change of NIHSS within 14 days.

Conditions

Interventions

  • Clopidogrel (Plavix®)Drug
    Other Names: Plavix
    ARM 1: Kind: Experimental
    Label: clopidogrel plus aspirin group
    Description: the group will receive a 300mg loading dose of clopidogrel, followed by clopidogrel 75 mg/d and aspirin 100 mg/d from day 2 to day 14, and followed by clopidogrel 75 mg/d or aspirin 100 mg/d from day 15 to day 90.
  • Aspirin Drug
    Other Names: Aspirin at bedtime
    ARM 1: Kind: Experimental
    Label: clopidogrel plus aspirin group
    Description: the group will receive a 300mg loading dose of clopidogrel, followed by clopidogrel 75 mg/d and aspirin 100 mg/d from day 2 to day 14, and followed by clopidogrel 75 mg/d or aspirin 100 mg/d from day 15 to day 90.
    ARM 2: Kind: Experimental
    Label: aspirin group
    Description: the group will receive 100-300 mg aspirin from day 1 to day 14, followed by aspirin 100 mg/d from day 15 to day 90.

Trial Design

  • Allocation: Randomized
  • Masking: Open Label
  • Purpose: Treatment
  • Endpoint: Safety/Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Early neurological deterioration assessed as no change of NIHSS 14 days No
Secondary new clinical vascular events (ischemic stroke/hemorrhagic stroke/TIA/myocardial infarction/vascular death) 90 days No
Secondary Changes in National Institute of Health stroke scale scores 14 days No
Secondary moderate to severe bleeding events 14 days Yes
Secondary Total mortality 90 days Yes
Secondary Adverse events/severe adverse events 90 days Yes
Primary Early neurological deterioration assessed as change of NIHSS 14 days

Sponsors