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Overcome Biochemical Aspirin Resistance Through Cilostazol Combination (ARCC)

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ClinicalTrials.gov Identifier: NCT00446641
Recruitment Status : Completed
First Posted : March 13, 2007
Results First Posted : January 18, 2010
Last Update Posted : January 18, 2010
Sponsor:
Collaborator:
Korea Otsuka Pharmaceutical Co., Ltd.
Information provided by:
Asan Medical Center

Study Description
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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.


Condition or disease Intervention/treatment Phase
Cerebral Infarction Drug: Cilostazol Drug: placebo Phase 4

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

[Methods]

  • 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
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 244 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase 4 Study of Additional Cilostazol for Overcoming Biochemical Aspirin Resistance in the Chronic Stroke Patients
Study Start Date : March 2007
Actual Primary Completion Date : June 2008
Actual Study Completion Date : July 2008

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. Aspirin Resistance (ARU ≥ 550) [ Time Frame: 4 weeks after treatment ]
    The number of patients with aspirin reaction units (ARUs) values ≥ 550 on the Ultra Rapid Platelet Function Assay-ASA among the recruited patients


Secondary Outcome Measures :
  1. Aspirin Resistance (ARU ≥ 500) [ Time Frame: 4 weeks after reatment ]
    The number of participants with ARUs values ≥500 on the Ultra Rapid Platelet Function Assay-ASA; ARUs values

  2. Bleeding Time (BT) [ Time Frame: 4 weeks after reatment ]
    for evaluation of the extent of the bleeding time prolongation by additional cilostazol

  3. Fatal or Major Bleeding Complications; [ Time Frame: events ocurred during study medication after randomization ]
    Fatal or life-threatening bleeding was defined as any fatal bleeding event, a drop in hemoglobin of ≥ 50g/L, or significant hypotension with need for inotropic agents, symptomatic intracranial hemorrhage, or transfusion of ≥ 4 units of red-blood cells or equivalent amount of whole blood. Major bleeding was defined as significantly disabling bleedings, intraocular bleeding leading to significant visual loss, or bleeding requiring transfusion of ≤ 3 units of red-blood cells or equivalent amount of whole blood

  4. Any Bleeding Complications [ Time Frame: events ocurred during study medication after randomization ]
    any bleeding events causing medical attention

  5. 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 ]
    summation of change of ARU (posttreatment ARU - baseline ARU) of individual patients

  6. Post-treatment ARU [ Time Frame: after 4 weeks treatment ]
    mean of ARU value of individual participants after 4 weeks treatment


Eligibility Criteria
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Ages Eligible for Study:   35 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00446641


Locations
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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.
Investigators
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Principal Investigator: Sun U Kwon, MD. PhD. Asan Medical Center, Univsersity of Ulsan, Medical College
More Information
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Responsible Party: Sun U. Kwon, Asan Medical Center
ClinicalTrials.gov Identifier: NCT00446641    
Other Study ID Numbers: ARCC
First Posted: March 13, 2007    Key Record Dates
Results First Posted: January 18, 2010
Last Update Posted: January 18, 2010
Last Verified: November 2009
Keywords provided by Asan Medical Center:
Infarction, Cerebral
Cilostazol
Aspirin Resistance
Additional relevant MeSH terms:
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Cerebral Infarction
Infarction
Ischemia
Pathologic Processes
Necrosis
Brain Infarction
Brain Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Stroke
Vascular Diseases
Cardiovascular Diseases
Cilostazol
 Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Vasodilator Agents
Neuroprotective Agents
Protective Agents
Phosphodiesterase 3 Inhibitors
Phosphodiesterase Inhibitors