The Effectiveness and Safety of Butylphthalide Soft Capsules in Secondary Prevention of Ischemic Stroke Trial "ESCAPE"

Recruiting

Phase 4 Results N/A

Trial Description

The purpose of the study is to evaluate the efficacy and safety of Butylphthalide Soft Capsules (En Bi Pu, NBP) in Secondary Prevention of Ischemic Stroke

Detailed Description

The efficacy and safety of Butylphthalide Soft Capsules (En Bi Pu, NBP)in acute ischemic stroke has been demonstrated in China recently. Its role in secondary prevention of ischemic stroke need to be evaluated.

Conditions

Interventions

  • Aspirin Drug
    Other Names: Aspirin at bedtime
    Intervention Desc: Aspirin 100mg Qd for 1 year
    ARM 1: Kind: Experimental
    Label: 2
    Description: Aspirin
  • Butylphthalide Soft Capsules Drug
    Other Names: Butylphthalide Soft Capsules, En Bi Pu (NBP)
    Intervention Desc: Butylphthalide Soft Capsules: 2 tablets Bid for 1 year Aspirin: 100mg for 1 year
    ARM 1: Kind: Experimental
    Label: 1
    Description: Butylphthalide Soft Capsules + Aspirin

Trial Design

  • Allocation: Randomized
  • Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
  • Purpose: Prevention
  • Endpoint: Safety/Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Newly onset ischemic stroke 1 year follow up Yes
Primary vascular events including newly onset TIA,intracerebral hemorrhage,myocardic infarction,unstable angina pectoris, occlusion of peripheral artery 1 year follow up Yes
Primary Small vessel disease defined by white matter lesions on MRI 1 year follow up Yes
Secondary All-cause death 1 year follow up Yes

Sponsors