PreventIon of IMT Progression in iSchemic Stroke Patients With High Risk of Cerebral HemOrrhage-IMT Study "PICASSO-IMT"

Active, not recruiting

Phase 4 Results N/A

Trial Description

Through this study, the investigators are to prove that Cilostazol effectively prevent progression of intima-medial thickness in ischemic stroke patients with high risk of cerebral hemorrhage, along with no significant increase in the risk of occurrence of hemorrhagic side effects.
The primary hypothesis of this study is; Cilostazol alone or with probucol will reduce the progression of intima-medial thickness compared to aspirin in the ischemic stroke patients with symptomatic or asymptomatic old cerebral hemorrhage.

Conditions

Interventions

  • Cilostazol (PletalĀ®)Drug
    Other Names: Claudiasil
    Intervention Desc: Cilostazol 100mg bid
    ARM 1: Kind: Experimental
    Label: Cilostazol+ Probucol
    Description: 100mg cilostazol bid plus probucol plus placebo of aspirin
    ARM 2: Kind: Experimental
    Label: Cilostazol
    Description: cilostazol plus placebo of aspirin
  • Aspirin Drug
    Other Names: clopidogrel; combination aspirin-dipyridamole
    Intervention Desc: Aspirin 100mg qd
    ARM 1: Kind: Experimental
    Label: Aspirin + Probucol
    Description: aspirin plus placebo cilostazol plus probucol
    ARM 2: Kind: Experimental
    Label: Aspirin
    Description: aspirin plus placebo of cilostazol
  • Probucol Drug
    Other Names: Probucol is produced by Otsuka Pharmaceutical
    Intervention Desc: Probucol 250mg bid
    ARM 1: Kind: Experimental
    Label: Cilostazol+ Probucol
    Description: 100mg cilostazol bid plus probucol plus placebo of aspirin
    ARM 2: Kind: Experimental
    Label: Aspirin + Probucol
    Description: aspirin plus placebo cilostazol plus probucol
  • Placebo of cilostazol Drug
    Intervention Desc: same shape and size of active cilostazol
    ARM 1: Kind: Experimental
    Label: Aspirin + Probucol
    Description: aspirin plus placebo cilostazol plus probucol
    ARM 2: Kind: Experimental
    Label: Aspirin
    Description: aspirin plus placebo of cilostazol
  • Placebo of aspirin Drug
    Intervention Desc: same size and shape of active aspirin 100mg
    ARM 1: Kind: Experimental
    Label: Cilostazol+ Probucol
    Description: 100mg cilostazol bid plus probucol plus placebo of aspirin
    ARM 2: Kind: Experimental
    Label: Cilostazol
    Description: cilostazol plus placebo of aspirin
  • Intima-medial thickness Device
    Other Names: - Annualized change of mean and maximum common carotid intima-medial thickness; - Annualized change of carotid plaque score
    Intervention Desc: ultrasound measured IMT of both common carotid arteries
    ARM 1: Kind: Experimental
    Label: Cilostazol+ Probucol
    Description: 100mg cilostazol bid plus probucol plus placebo of aspirin
    ARM 2: Kind: Experimental
    Label: Aspirin + Probucol
    Description: aspirin plus placebo cilostazol plus probucol
    ARM 3: Kind: Experimental
    Label: Cilostazol
    Description: cilostazol plus placebo of aspirin
    ARM 4: Kind: Experimental
    Label: Aspirin
    Description: aspirin plus placebo of cilostazol

Trial Design

  • Allocation: Randomized
  • Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
  • Purpose: Treatment
  • Endpoint: Efficacy Study
  • Intervention: Factorial Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary mean carotid IMT progression one year No
Secondary maximum carotid IMT progression one year No
Secondary carotid plaque score one year No

Sponsors