NCT00446641

Brief Summary

This study will recruit 316 ischemic stroke patients taking aspirin. They will be randomly assigned into cilostazol group or placebo group. Every patients will take 200mg of cilostazol a day or placebo for 1 month. The primary outcome variable of this study is rate of biochemical aspirin resistance on the Ultra Rapid Platelet Function Assay-ASA.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
244

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Mar 2007

Geographic Reach
1 country

4 active sites

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

March 1, 2007

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

March 12, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 13, 2007

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2008

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2008

Completed
1.6 years until next milestone

Results Posted

Study results publicly available

January 18, 2010

Completed
Last Updated

January 18, 2010

Status Verified

November 1, 2009

Enrollment Period

1.3 years

First QC Date

March 12, 2007

Results QC Date

January 22, 2009

Last Update Submit

December 10, 2009

Conditions

Cerebral Infarction

Keywords

Infarction, CerebralCilostazolAspirin Resistance

Outcome Measures

Primary Outcomes (1)

  • Aspirin Resistance (ARU ≥ 550)

    The number of patients with aspirin reaction units (ARUs) values ≥ 550 on the Ultra Rapid Platelet Function Assay-ASA among the recruited patients

    4 weeks after treatment

Secondary Outcomes (6)

  • Aspirin Resistance (ARU ≥ 500)

    4 weeks after reatment

  • Bleeding Time (BT)

    4 weeks after reatment

  • Fatal or Major Bleeding Complications;

    events ocurred during study medication after randomization

  • Any Bleeding Complications

    events ocurred during study medication after randomization

  • Difference of Post-treatment ARU and Baseline ARU

    baseline ARU measured at the randomization and post-treatment ARU measured at the 4weeks treatment with study medication

  • +1 more secondary outcomes

Study Arms (2)

1 Cilostazol

EXPERIMENTAL

100mg of Cilostazol twice a day

Drug: Cilostazol

Placebo

PLACEBO COMPARATOR

matching placebo to cilostazol

Drug: placebo

Interventions

CilostazolDRUG

cilostazol 100mg twice a day for 4 weeks

Also known as: pletaal
1 Cilostazol
placeboDRUG

placebo 1 tablet twice a day matching for cilostazol

Also known as: matching placebo of cilostazol
Placebo

Eligibility Criteria

Age35 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Symptomatic cerebral infarction documented on MRI or CT
  • More than 35 years of age
  • Patients taking aspirin 100mg a day for 2 weeks or more before randomization

You may not qualify if:

  • Patients taking any antiplatelets other than aspirin within 2 weeks before randomization
  • Patients taking any anticoagulants within 2 weeks before randomization
  • Patients taking thrombolytic therapy within 2 weeks before randomization
  • Patients taking any NSAIDs within 2 weeks before randomization
  • Patients who need to take NSAIDs regularly (e.g. rheumatic arthritis).
  • Bleeding diathesis
  • Chronic liver disease (ALT \> 100 or AST \> 100) or chronic renal disease (creatinine \> 3.0mg/dl)
  • Anemia (hemoglobin \< 10mg/dl) or thrombocytopenia (platelet count less than 100,000/mm3)
  • Pregnant or lactating patients
  • Patients scheduled for angioplasty or revascularization procedures within 4 weeks
  • Patients scheduled for any surgery or invasive procedures within 4 weeks
  • Patients having acute coronary syndrome

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Jae-Kwan Cha

Busan, Busan, 602-715, South Korea

Location

Eulji University Hospital

Daejeon, 302-799, South Korea

Location

Kangdong Sacred Heart Hospital, Hallym University

Seoul, 134-701, South Korea

Location

Asan Medical Center

Seoul, 138-736, South Korea

Location

MeSH Terms

Conditions

Cerebral Infarction

Interventions

Cilostazol

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-Ring

Results Point of Contact

Title
Professor Sun U. Kwon
Organization
Asan Medical Center, University of Ulsan College of Medicine
sukwon@amc.seoul.kr
82-2-3010-3960

Study Officials

  • Sun U Kwon, MD. PhD.

    Asan Medical Center, Univsersity of Ulsan, Medical College

    PRINCIPAL INVESTIGATOR

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
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 12, 2007

First Posted

March 13, 2007

Study Start

March 1, 2007

Primary Completion

June 1, 2008

Study Completion

July 1, 2008

Last Updated

January 18, 2010

Results First Posted

January 18, 2010

Record last verified: 2009-11

Locations

KR(4)