INdobufen Versus aSpirin in acUte Ischemic stRokE,INSURE
Condition: Ischemic Stroke; Indobufen; Aspirin
MeSH terms: Stroke; Ischemic Stroke; Cerebral Infarction; Ischemia
Study type: Interventional
Phase: Phase 4

Summary: 
      China has the largest burden of cerebrovascular disease in the world. About 60% to 80% of
      which are ischemic stroke. In recent years, stroke has replaced heart disease and tumor
      diseases as the first cause of death and disability in adult population. The primary purpose
      of this study is to evaluate the efficacy of indobufen treatment in reducing the risk of a
      3-month new stroke (any type of stroke, including ischemic stroke and hemorrhagic stroke) for
      patients with moderate/severe ischemic stroke is not inferior to aspirin therapy.
    

Detailed description: 
      China has the largest burden of cerebrovascular disease in the world. About 60% to 80% of
      which are ischemic stroke. In recent years, stroke has replaced heart disease and tumor
      diseases as the first cause of death and disability in adult population. The primary purpose
      of this study is to evaluate the efficacy of indobufen treatment in reducing the risk of a
      3-month new stroke (any type of stroke, including ischemic stroke and hemorrhagic stroke) for
      patients with moderate/severe ischemic stroke is not inferior to aspirin therapy. The study
      is a multicenter, randomized, double-blind, positive drug parallel control and
      non-inferiority clinical design.

      Non-inferiority analysis was performed on the primary efficacy analysis, and both intent
      analysis (ITT) and compliance program set (PPS) were used for analysis. If the indobufen
      group was confirmed to be non-inferior to aspirin (control group), a superiority analysis was
      further performed to analyze whether the indobufen was superior to aspirin. At the same time,
      Kaplan-Meier curves were used to simulate the cumulative risk of stroke (ischemic or
      hemorrhagic) at 90-day follow-up, and the Cox proportional hazards model was used to
      calculate the hazard ratio (HR) and 95% confidence interval, Log-rank test was used to
      evaluate the treatment effect. All statistics will be two-sided with p<0.05 considered
      significant.

      All patients who received study drugs and with at least one safety follow-up record will be
      included in the safety population. The data for safety evaluation included adverse reactions
      observed during the trial and changes in laboratory data before and after treatment.
    

Intervention name(s): Indobufen; Aspirin
Intervention type(s): Drug; Drug
Intervention description(s): Indobufen inhibits platelet aggregation by reversibly inhibiting the platelet cyclooxygenase enzyme thereby suppressing thromboxane synthesis.; Aspirin is a salicylate (sa-LIS-il-ate). It works by reducing substances in the body that cause pain, fever, and inflammation.
Intervention MeSH terms: Aspirin; Indobufen
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment