Exploratory Study on the Effects of Early Rosuvastatin Treatment in Patients With Acute Ischemic Stroke "AIS"

Not yet recruiting

Phase 4 Results N/A

Trial Description

This is an exploratory, randomized, open-label, 2-arm, parallel-group study exploring the efficacy of rosuvastatin (20mg/day) in patients with acute ischemic stroke.

Detailed Description

This is a 90-day, explanatory; randomized; open-label, 2-arm; parallel group with blinded outcome evaluation study exploring the efficacy and study of early rosuvastatin 20 mg/d treatment in acute ischemic patients with stroke onset in 24 hours.

Conditions

Interventions

  • Rosuvastatin (Crestor)Drug
    Intervention Desc: Randomized Treatment Period (Day 1 through Day 14): 20 mg once daily for 14 days. Follow up Period (Day 15 through Day 90) Subjects in both groups who enter the follow up period will receive rosuvastatin 10mg/day.
    ARM 1: Kind: Experimental
    Label: Rosuvastatin
    Description: Rosuvastatin study drug will be supplied in tablets (10 mg), assigned dose to be taken orally, once daily by subjects randomized to receive rosuvastatin 20 mg(take rosuvastatin until 14th day).
  • Control Device
    Intervention Desc: Randomized Treatment Period (Day 1 through Day 14): No treatment of rosuvastatin for control group. Follow up Period (Day 15 through Day 90) Subjects in both groups who enter the follow up period will receive rosuvastatin 10mg/day.
    ARM 1: Kind: Experimental
    Label: Rosuvastatin
    Description: Rosuvastatin study drug will be supplied in tablets (10 mg), assigned dose to be taken orally, once daily by subjects randomized to receive rosuvastatin 20 mg(take rosuvastatin until 14th day).

Trial Design

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

Outcomes

Type Measure Time Frame Safety Issue
Primary Percent changes in infarction volumes measured by MRI on the 14th day compared with the baseline of the stroke 0-14d No
Secondary Absolute changes in infarction volumes measured by MRI on the 14th day compared with the baseline of the stroke 0-14d No
Secondary Proportion of patients whose infarction volume reduced on the 14th day compared with the baseline of the stroke 0-14d No
Secondary The neurological outcomes measured by NIHSS (14,90 days), compared between statin group and standard group 14-90d No
Secondary The functional outcome measured by modified Rankin Scale (14,90 days), compared between statin group and standard group 14-90d No
Secondary The rate of the new-onset infarct assessed by MRI from baseline to 14th day, compared between statin group and standard group 0-14d No

Sponsors