Overcome Biochemical Aspirin Resistance Through Cilostazol Combination (ARCC)

This study has been completed.
Korea Otsuka Pharmaceutical Co.,Ltd.
Information provided by:
Asan Medical Center
ClinicalTrials.gov Identifier:
First received: March 12, 2007
Last updated: December 10, 2009
Last verified: November 2009

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.

Condition Intervention Phase
Cerebral Infarction
Drug: Cilostazol
Drug: placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase 4 Study of Additional Cilostazol for Overcoming Biochemical Aspirin Resistance in the Chronic Stroke Patients

Resource links provided by NLM:

Further study details as provided by Asan Medical Center:

Primary Outcome Measures:
  • Aspirin Resistance (ARU ≥ 550) [ Time Frame: 4 weeks after treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Aspirin Resistance (ARU ≥ 500) [ Time Frame: 4 weeks after reatment ] [ Designated as safety issue: No ]
  • Bleeding Time (BT) [ Time Frame: 4 weeks after reatment ] [ Designated as safety issue: Yes ]
  • Fatal or Major Bleeding Complications; [ Time Frame: events ocurred during study medication after randomization ] [ Designated as safety issue: Yes ]
  • Any Bleeding Complications [ Time Frame: events ocurred during study medication after randomization ] [ Designated as safety issue: Yes ]
  • Difference of Post-treatment ARU and Baseline ARU [ Time Frame: baseline ARU measured at the randomization and post-treatment ARU measured at the 4weeks treatment with study medication ] [ Designated as safety issue: No ]
  • Post-treatment ARU [ Time Frame: after 4 weeks treatment ] [ Designated as safety issue: No ]

Enrollment: 244
Study Start Date: March 2007
Study Completion Date: July 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Cilostazol
100mg of Cilostazol twice a day
Drug: Cilostazol
cilostazol 100mg twice a day for 4 weeks
Other Name: pletaal
Placebo Comparator: Placebo
matching placebo to cilostazol
Drug: placebo
placebo 1 tablet twice a day matching for cilostazol
Other Name: matching placebo of cilostazol

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

[Participants] Ischemic stroke patients taking aspirin


  • Double-Blind, Placebo-Controlled, Randomized, Multicenter Trial
  • Investigational product: Cilostazol 200mg (100mg twice per day)
  • Concomitant medication: Aspirin 100 mg per day
  • Medication Duration: 1 month

[Outcome Variables]

Primary Outcome Variable:

• the proportion of patients with aspirin reaction units (ARUs) values ≥550 on the Ultra Rapid Platelet Function Assay-ASA

Secondary outcome variables:

  • the proportion of patients with ARUs values ≥500 on the Ultra Rapid Platelet Function Assay-ASA
  • ARUs values
  • Bleeding time (BT)
  • Fatal or major bleeding complications
  • Any bleeding complications

Ages Eligible for Study:   35 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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 Criteria:

  • 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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00446641

Korea, Republic of
Jae-Kwan Cha
Busan, Korea, Republic of, 602-715
Eulji University Hospital
Daejon, Korea, Republic of, 302-799
Kangdong Sacred Heart Hospital, Hallym University
Seoul, Korea, Republic of, 134-701
Asan Medical Center
Seoul, Korea, Republic of, 138-736
Sponsors and Collaborators
Asan Medical Center
Korea Otsuka Pharmaceutical Co.,Ltd.
Principal Investigator: Sun U Kwon, MD. PhD. Asan Medical Center, Univsersity of Ulsan, Medical College
  More Information

Responsible Party: Sun U. Kwon, Asan Medical Center
ClinicalTrials.gov Identifier: NCT00446641     History of Changes
Other Study ID Numbers: ARCC 
Study First Received: March 12, 2007
Results First Received: January 22, 2009
Last Updated: December 10, 2009
Health Authority: Korea: Food and Drug Administration

Keywords provided by Asan Medical Center:
Infarction, Cerebral
Aspirin Resistance

Additional relevant MeSH terms:
Cerebral Infarction
Pathologic Processes
Brain Infarction
Brain Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on August 22, 2016