Trial of Cilostazol in Symptomatic Intracranial Arterial Stenosis II "TOSS-2"

Completed

Phase 4 Results

Trial Description

This study will recruit 480 acute stroke patients with symptomatic intracranial stenosis (M1 segment of Middle cerebral artery (MCA) or basilar artery).
They will be randomly assigned into cilostazol group or clopidogrel group. Every patients will take 100mg of aspirin a day additionally.
The primary outcome variable of this study is Progression rate of symptomatic intracranial stenosis on magnetic resonance angiogram (MRA).

Detailed Description

[Goal] To Reveal the Effect and Safety of Cilostazol Compared with Clopidogrel on the Prevention of the Progression of Symptomatic Intracranial Arterial Stenosis.
[Trial Design] Double-Blind, Active-Controlled, Randomized, Multicenter Trial
[Participants] Acute ischemic stroke patients with symptomatic intracranial arterial stenosis
[Methods]
- Double-Blind, Active-Controlled, Randomized, Multicenter Trial
- Investigational product (Double Dummy Method):
Cilostazol 200mg (100mg twice per day) versus clopidogrel 75mg
- Concomitant medication: Aspirin 100 (75-150) mg per day
- Medication Duration: 7 months
[Outcome Variables]
Primary Outcome Variable:
- Progression rate of symptomatic intracranial arterial stenosis
Secondary outcome variables:
- The occurrence of new MRI (magnetic resonance image) lesion on follow-up MRI
- Stroke events
- Overall cardiovascular events: stroke, acute coronary syndrome, vascular death
- Ipsilateral ischemic stroke rate
- Fatal or major bleeding complications

Conditions

Interventions

  • Aspirin (stroke prevention) Drug
    Intervention Desc: Antiplatelet agent; inhibits thromboxane A2
  • Clopidogrel (Plavix┬«)Drug
    Other Names: Plavix
    Intervention Desc: Clopidogrel 75mg once a day plus placebo of cilostazol twice a day
    ARM 1: Kind: Experimental
    Label: Clopidogrel
    Description: clopidogrel 75mg qd and matching placebo of cilostazol
  • Cilostazol (Pletal┬«)Drug
    Other Names: Claudiasil
    Intervention Desc: Cilostazol 100mg twice a day plus placebo of clopidogrel once a day
    ARM 1: Kind: Experimental
    Label: cilostazol
    Description: cilostazol 100mg bid plus placebo of clopidogrel

Trial Design

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

Patient Involvement

Patients will be randomized into cilostazol group (cilostazol 100mg twice a day and dummy cliopidogrel) or clopidogrel group (clopidogrel 75 mg a day and dummy cilostazol). They will also take 75-125mg aspirin per day with study medication for 7 months.

Outcomes

Type Measure Time Frame Safety Issue
Primary The progression of SIS on MRA.
Secondary Occurrence of new MRI lesion on follow-up MRI; stroke events; overall cardiovascular events: stroke, acute coronary syndrome, vascular death; ipsilateral ischemic stroke rate; fatal or major bleeding complications.
Primary Number of Participants With Progression of Symptomatic Intracranial Stenosis 7 months after treatment No
Secondary Number of Participants With New MRI (Magnetic Resonance Image) Lesions on Follow-up MRI 7 months after treatment No
Secondary Number of Participants With Stroke Events upto 7 months after randomization No
Secondary Number of Participants With Overall Cardiovascular Events upto 7 months after randomization No
Secondary Number of Patients With Ipsilateral Ischemic Stroke Rate upto 7 months after randomization No
Secondary Numbers of Fatal or Major Bleeding Complications upto 7 months after randomization Yes

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