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Overcome Biochemical Aspirin Resistance Through Cilostazol Combination (ARCC)

Primary Purpose

Cerebral Infarction

Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Cilostazol
placebo
Sponsored by
Asan Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cerebral Infarction focused on measuring Infarction, Cerebral, Cilostazol, Aspirin Resistance

Eligibility Criteria

35 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Jae-Kwan Cha
  • Eulji University Hospital
  • Kangdong Sacred Heart Hospital, Hallym University
  • Asan Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

1 Cilostazol

Placebo

Arm Description

100mg of Cilostazol twice a day

matching placebo to cilostazol

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Aspirin Resistance (ARU ≥ 500)
The number of participants with ARUs values ≥500 on the Ultra Rapid Platelet Function Assay-ASA; ARUs values
Bleeding Time (BT)
for evaluation of the extent of the bleeding time prolongation by additional cilostazol
Fatal or Major Bleeding Complications;
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
Any Bleeding Complications
any bleeding events causing medical attention
Difference of Post-treatment ARU and Baseline ARU
summation of change of ARU (posttreatment ARU - baseline ARU) of individual patients
Post-treatment ARU
mean of ARU value of individual participants after 4 weeks treatment

Full Information

First Posted
March 12, 2007
Last Updated
December 10, 2009
Sponsor
Asan Medical Center
Collaborators
Korea Otsuka Pharmaceutical Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT00446641
Brief Title
Overcome Biochemical Aspirin Resistance Through Cilostazol Combination
Acronym
ARCC
Official Title
Phase 4 Study of Additional Cilostazol for Overcoming Biochemical Aspirin Resistance in the Chronic Stroke Patients
Study Type
Interventional

2. Study Status

Record Verification Date
November 2009
Overall Recruitment Status
Completed
Study Start Date
March 2007 (undefined)
Primary Completion Date
June 2008 (Actual)
Study Completion Date
July 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Asan Medical Center
Collaborators
Korea Otsuka Pharmaceutical Co., Ltd.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Infarction
Keywords
Infarction, Cerebral, Cilostazol, Aspirin Resistance

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
244 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1 Cilostazol
Arm Type
Experimental
Arm Description
100mg of Cilostazol twice a day
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
matching placebo to cilostazol
Intervention Type
Drug
Intervention Name(s)
Cilostazol
Other Intervention Name(s)
pletaal
Intervention Description
cilostazol 100mg twice a day for 4 weeks
Intervention Type
Drug
Intervention Name(s)
placebo
Other Intervention Name(s)
matching placebo of cilostazol
Intervention Description
placebo 1 tablet twice a day matching for cilostazol
Primary Outcome Measure Information:
Title
Aspirin Resistance (ARU ≥ 550)
Description
The number of patients with aspirin reaction units (ARUs) values ≥ 550 on the Ultra Rapid Platelet Function Assay-ASA among the recruited patients
Time Frame
4 weeks after treatment
Secondary Outcome Measure Information:
Title
Aspirin Resistance (ARU ≥ 500)
Description
The number of participants with ARUs values ≥500 on the Ultra Rapid Platelet Function Assay-ASA; ARUs values
Time Frame
4 weeks after reatment
Title
Bleeding Time (BT)
Description
for evaluation of the extent of the bleeding time prolongation by additional cilostazol
Time Frame
4 weeks after reatment
Title
Fatal or Major Bleeding Complications;
Description
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
Time Frame
events ocurred during study medication after randomization
Title
Any Bleeding Complications
Description
any bleeding events causing medical attention
Time Frame
events ocurred during study medication after randomization
Title
Difference of Post-treatment ARU and Baseline ARU
Description
summation of change of ARU (posttreatment ARU - baseline ARU) of individual patients
Time Frame
baseline ARU measured at the randomization and post-treatment ARU measured at the 4weeks treatment with study medication
Title
Post-treatment ARU
Description
mean of ARU value of individual participants after 4 weeks treatment
Time Frame
after 4 weeks treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sun U Kwon, MD. PhD.
Organizational Affiliation
Asan Medical Center, Univsersity of Ulsan, Medical College
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jae-Kwan Cha
City
Busan
ZIP/Postal Code
602-715
Country
Korea, Republic of
Facility Name
Eulji University Hospital
City
Daejon
ZIP/Postal Code
302-799
Country
Korea, Republic of
Facility Name
Kangdong Sacred Heart Hospital, Hallym University
City
Seoul
ZIP/Postal Code
134-701
Country
Korea, Republic of
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
138-736
Country
Korea, Republic of

12. IPD Sharing Statement

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Overcome Biochemical Aspirin Resistance Through Cilostazol Combination

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