Cilostazol Stroke Prevention Study for Antiplatelet Combination "CSPS・com"

Recruiting

Phase 3 Results N/A

Trial Description

To examine the efficacy and safety of dual antiplatelet therapy (DAPT) including cilostazol (Pletaal OD Tablet ®) in comparison with antiplatelet monotherapy (excluding cilostazol) for secondary prevention of ischemic stroke in high-risk patients for stroke

Conditions

Interventions

  • Clopidogrel (Plavix®)Drug
    Other Names: Plavix
    Intervention Desc: Clopidogrel (50mg or 75mg) will be orally administered once daily.The treatment period will begin with the first visit of the first subject and end one year after the first visit of the last subject.
    ARM 1: Kind: Experimental
    Label: Monotherapy group
    Description: Aspirin (81mg or 100mg) or clopidogrel (50mg or 75mg) will be orally administered once daily. The treatment period will begin with the first visit of the first subject and end one year after the first visit of the last subject.
    ARM 2: Kind: Experimental
    Label: DAPT group
    Description: Cilostazol (100mg twice daily) will be orally administered in combination with aspirin (81 or 100mg once daily) or clopidogrel (50 or 75mg once daily). The treatment period will begin with the first visit of the first subject and end one year after the first visit of the last subject.
  • Cilostazol (Pletal®)Drug
    Other Names: Claudiasil
    Intervention Desc: Cilostazol (100mg twice daily) will be orally administered. The treatment period will begin with the first visit of the first subject and end one year after the first visit of the last subject.
    ARM 1: Kind: Experimental
    Label: DAPT group
    Description: Cilostazol (100mg twice daily) will be orally administered in combination with aspirin (81 or 100mg once daily) or clopidogrel (50 or 75mg once daily). The treatment period will begin with the first visit of the first subject and end one year after the first visit of the last subject.
  • Aspirin Drug
    Other Names: Aspirin at bedtime
    Intervention Desc: Aspirin (81mg or 100mg) will be orally administered once daily.The treatment period will begin with the first visit of the first subject and end one year after the first visit of the last subject.
    ARM 1: Kind: Experimental
    Label: Monotherapy group
    Description: Aspirin (81mg or 100mg) or clopidogrel (50mg or 75mg) will be orally administered once daily. The treatment period will begin with the first visit of the first subject and end one year after the first visit of the last subject.
    ARM 2: Kind: Experimental
    Label: DAPT group
    Description: Cilostazol (100mg twice daily) will be orally administered in combination with aspirin (81 or 100mg once daily) or clopidogrel (50 or 75mg once daily). The treatment period will begin with the first visit of the first subject and end one year after the first visit of the last subject.

Trial Design

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

Outcomes

Type Measure Time Frame Safety Issue
Primary Recurrence of symptomatic ischemic stroke, with the symptoms lasting for at least 24 hours every 6 months No
Secondary Any stroke [ischemic stroke (IS), intracerebral hemorrhage (ICH), subarachnoid hemorrhage (SAH)] every 6 months No
Secondary SAH or ICH every 6 months No
Secondary IS or transient ischemic attack (TIA) every 6 months No
Secondary Death from any cause every 6 months No
Secondary Stroke (IS,ICH,SAH), myocardial infarction (MI), or vascular death every 6 months No
Secondary All vascular events: stroke, MI, and other vascular events every 6 months No
Secondary Adverse events and adverse drug reactions every 6 months Yes
Secondary Severe or life-threatening hemorrhage (GUSTO Criteria) every 6 months Yes

Sponsors