NCT00234065

Brief Summary

The purpose of this study is to investigate the efficacy of cilostazol in preventing recurrence of cerebral infarction and the safety of long-term administration of the drug (100 mg, twice daily) in patients with cerebral infarction (excluding cardiogenic cerebral embolism) in a multi-center, double-blind, parallel-group comparison with aspirin (81 mg, once daily).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,800

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Dec 2003

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2003

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

October 4, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 6, 2005

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
2.4 years until next milestone

Results Posted

Study results publicly available

May 13, 2011

Completed
Last Updated

June 10, 2011

Status Verified

June 1, 2011

Enrollment Period

5 years

First QC Date

October 4, 2005

Results QC Date

April 19, 2011

Last Update Submit

June 9, 2011

Conditions

Cerebral Infarction

Outcome Measures

Primary Outcomes (1)

  • Numbers of Patients With First Occurence of Stroke

    The endpoint in this measure is a composite endpoint of the first recurrence of cerebral infarction, or occurrence of cerebral haemorrhage or subarachnoid haemorrhage. The evaluation committee, whose members were unaware of patients' treatment assignment, adjudicated all trial endpoints.

    From start of treatment to end of follow-up period ( follow-up periods : 29 months [Standard Deviation 16, range 1-59 months])

Secondary Outcomes (4)

  • Number of Patients With First Recurrence of Cerebral Infarction

    From start of treatment to end of follow-up period (mean follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])

  • Number of Patients With First Occurrence of Ischaemic Cerebrovascular Disease

    From start of treatment to end of follow-up period ( follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])

  • Number of Deaths From Any Cause

    From start of treatment to end of follow-up period ( follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])

  • Number of Patients With First Occurrence of a Composite Endpoint of Stroke, Haemorrhagic Events, or Cardiovascular Events

    From start of treatment to end of follow-up period ( follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])

Other Outcomes (1)

  • Number of Patients With First Occurrence of Haemorrhagic Event

    From start of treatment to end of follow-up period ( follow-up periods : 29 months [STANDARD DEVIATION 16, range 1-59 months])

Study Arms (2)

1

EXPERIMENTAL

cilostazol

Drug: Cilostazol

2

ACTIVE COMPARATOR

Aspirin

Drug: Aspirin

Interventions

CilostazolDRUG

oral tablet, 100 mg twice a day and placebo of aspirin once a day, 1 to 5years

1
AspirinDRUG

oral tablet, placebo of cilostazol twice a day and 81 mg once a day, 1 to 5 years

2

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with stable medical conditions for 182 days (26 weeks) after occurrence of cerebral infarction
  • Patients in whom the infarct-related foci was detected by X-ray CT scan or MRI
  • Patients aged 20 to 80 years (inclusive) at time of consent
  • Patients with none of the following cardiac diseases that may be associated with cardiogenic cerebral embolism: mitral stenosis, prosthetic heart valve, endocarditis, myocardial infarction within 6 weeks after occurrence, ventricular aneurysm, endocardial thrombosis, mitral valve prolapse (patients less than 45 years of age in whom no other cause was identified), atrial fibrillation, sick sinus syndrome, idiopathic cardiomyopathy, and patent foramen ovale
  • Patients without asymptomatic cerebral infarction
  • Patients who have neither undergone nor are scheduled to undergo percutaneous transluminal angioplasty or revascularization for the treatment of cerebral infarction
  • Patients without severe disturbances/impairments following occurrence of cerebral

You may not qualify if:

  • Patients with hemorrhage or bleeding tendency (hemophilia, capillary fragility, intracranial hemorrhage, hemorrhage in the digestive tract, hemorrhage in the urinary tract, hemoptysis, and hemorrhage in the vitreous body)
  • Pregnant, possibly pregnant, or nursing women
  • Patients with ischemic heart failure
  • Patients with peptic ulcer
  • Patients with severer blood disorders
  • Patients with severe hepatic or renal
  • Patients with malignant neoplasm or patients who have received any therapy for malignant neoplasm within 5 years prior to entering the study
  • Patients with a history of hypersensitivity to salicylic acid formulations or ingredients of cilostazol tablets
  • Patients with aspirin asthma (asthma attacks induced by nonsteroidal antiinflammatory analgesic agents) or a history of aspirin asthma
  • Patients who are being treated with ticlopidine hydrochloride
  • Patients who are participating in another study for an investigational drug

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Otsuka Pharmaceutical Co., Ltd.

Tokyo, Japan

Location

Related Publications (1)

  • Shinohara Y, Katayama Y, Uchiyama S, Yamaguchi T, Handa S, Matsuoka K, Ohashi Y, Tanahashi N, Yamamoto H, Genka C, Kitagawa Y, Kusuoka H, Nishimaru K, Tsushima M, Koretsune Y, Sawada T, Hamada C; CSPS 2 group. Cilostazol for prevention of secondary stroke (CSPS 2): an aspirin-controlled, double-blind, randomised non-inferiority trial. Lancet Neurol. 2010 Oct;9(10):959-68. doi: 10.1016/S1474-4422(10)70198-8. Epub 2010 Sep 15.

    PMID: 20833591RESULT

MeSH Terms

Conditions

Cerebral Infarction

Interventions

CilostazolAspirin

Condition Hierarchy (Ancestors)

Brain InfarctionBrain IschemiaCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesStrokeVascular DiseasesCardiovascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Intervention Hierarchy (Ancestors)

TetrazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsQuinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingSalicylatesHydroxybenzoatesPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Results Point of Contact

Title
Masahiko Abe, Director Cardiovascular Projects
Organization
Department of Clinical Research and Development, Otsuka Pharmaceutical Co., Ltd.
abems@otsuka.jp
+81-6-6943-7722

Study Officials

  • Masahiko Abe

    Division of New Product Evaluation and Development

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

October 4, 2005

First Posted

October 6, 2005

Study Start

December 1, 2003

Primary Completion

December 1, 2008

Study Completion

December 1, 2008

Last Updated

June 10, 2011

Results First Posted

May 13, 2011

Record last verified: 2011-06

Locations

JP(1)