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Status:

COMPLETED

Overcome Biochemical Aspirin Resistance Through Cilostazol Combination

Lead Sponsor:

Asan Medical Center

Collaborating Sponsors:

Korea Otsuka Pharmaceutical Co., Ltd.

Conditions:

Cerebral Infarction

Eligibility:

All Genders

35+ years

Phase:

PHASE4

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 place...

Detailed Description

\[Goal\] To reveal the effect and safety of additional cilostazol for overcoming biochemical aspirin resistance. \[Trial Design\] Double-Blind, Placebo-Controlled, Randomized, Multicenter Trial \[Pa...

Eligibility Criteria

Inclusion

  • 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

Exclusion

  • 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

Key Trial Info

Start Date :

March 1 2007

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

July 1 2008

Estimated Enrollment :

244 Patients enrolled

Trial Details

Trial ID

NCT00446641

Start Date

March 1 2007

End Date

July 1 2008

Last Update

January 18 2010

Active Locations (4)

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Page 1 of 1 (4 locations)

1

Jae-Kwan Cha

Busan, Busan, South Korea, 602-715

2

Eulji University Hospital

Daejeon, South Korea, 302-799

3

Kangdong Sacred Heart Hospital, Hallym University

Seoul, South Korea, 134-701

4

Asan Medical Center

Seoul, South Korea, 138-736