Cilostazol-Aspirin Therapy Against Recurrent Stroke With Intracranial Artery Stenosis

• Status: Completed
• Trial end date: 2012-03-01
• Target enrollment: 0
• Participant gender: All

Summary

Multi-center, open-labelled randomized controlled trial, to study the effect of aspirin plus cilostazol and aspirin alone on the progression of intracranial arterial stenosis, in 200 chronic stroke patients with 50-99% stenosis, to be followed up for 2 years

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan; Translational Research Informatics Center, Kobe, Hyogo, Japan
• Collaborators: China National Center for Cardiovascular Diseases; Department of Neurology, Saiseikai Central Hospital; Foundation for Biomedical Research and Innovation; Kobe City General Hospital; Kyushu University; Neurology, Tokyo Women's Medical University, School of Medicine; Tohoku University
• Treatments: Aspirin; Cilostazol

Criteria

Inclusion Criteria:

• (1) Ischemic stroke after two weeks to six months from onset,

• (2) Responsible lesion identified on MRI,

• ( 3) Intracranial arterial stenosis >50% on MRA in the territory of responsible lesion,

• (4) Intracranial arterial stenosis in suproclinoid internal carotid arterry, M1 portion of midlle cerebral artery, or basilar artery,

• (5) Age of 45 to 85 years,

• (6) Able to visit out-patient clinic, and

• (7) Written informed consent obtained from patient or family.

Exclusion Criteria:

• (1) Patients with potential cardiac embolic sources,

• (2) Patients receiving cilostazol,

• (3) Patients on warfarin treatment,

• (4) Patients in whom MRI cannot be perfomed,

• (5) Patients in whom PTA or bypass surgery is planned,

• (6) Patients with history of symptomatic intracranial hemorrhage, other hemorrhagic diseases (active peptic ulcer etc.), hemophilia or coagulation abnormalities,

• (7) Patients with hypersensitivity to cilostazol or aspirin,

• (8) Patients with congestive heart failure or uncontrollable angina pectoris,

• (9) Patients with thrombocytopenia (<100,000/mm3),

• (10) Patients with liver dysfunction (AST or ALT >100 IU/L),

• (11) Patients with renal dysfunction (Creatinin >2.0 mg/dl),

• (12) Patients who cannot to be followed up during the study period,

• (13) Patients who are enrolled in other clinical trials, and

• (14) Patients inadequate for this study by other reasons.