Cilostazol-Aspirin Therapy Against Recurrent Stroke With Intracranial Artery Stenosis

NCT00333164 | Completed Phase 3

• 1 other identifier: UHA STROKE04-01
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Cerebrovascular Disease

Keywords

intracranial arteriosclerosis; cilostazol; Platelete aggrigation inhibitors dual antiplatelet therapy; Drug therapy, combination; Clinical trials

Outcome Measures

Primary Outcomes (1)

• Progression of intracranial arterial stenosis after two years

Secondary Outcomes (3)

• Cardiovascular events (ischemic stroke, cardiac infarctin, and other vascular events ）,

• death (stroke death, vascular death except for stroke ）,

• serious adverse events, new silent brain infarcts, and degrees of activity of daily living.

Interventions

Asprin, Cilostazol DRUG

Eligibility Criteria

• Age: 45 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• (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.

You may not qualify if:

• (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.

Sponsors & Collaborators

• Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan: lead
• Foundation for Biomedical Research and Innovation: collaborator
• Neurology, Tokyo Women's Medical University, School of Medicine: collaborator
• Kobe City General Hospital: collaborator
• Tohoku University: collaborator
• Kyushu University: collaborator
• Department of Neurology, Saiseikai Central Hospital: collaborator
• China National Center for Cardiovascular Diseases: collaborator

Study Sites (1)

Tokyo Women's Medical University School of Medicine

Shinjuku-ku, Tokyo, 162-8666, Japan

Location

MeSH Terms

Conditions

Cerebrovascular Disorders; Intracranial Arteriosclerosis

Interventions

Cilostazol

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Intracranial Arterial Diseases; Arteriosclerosis; Arterial Occlusive Diseases

Intervention Hierarchy (Ancestors)

Tetrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Shinichiro Uchiyama, M.D. PhD

  Department of Neurology, Tokyo Women's Medical University School of Medicine

  PRINCIPAL INVESTIGATOR

• Nobuyuki Sakai, M.D. PhD

  Kobe City General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 1, 2006
• First Posted: June 2, 2006
• Study Start: May 1, 2006
• Primary Completion: March 1, 2012
• Study Completion: March 1, 2012
• Last Updated: December 19, 2017

Record last verified: 2012-08

Locations

JP (1)