Overcome Biochemical Aspirin Resistance Through Cilostazol Combination (ARCC)

This study has been completed.
Sponsor:
Collaborator:
Korea Otsuka Pharmaceutical Co.,Ltd.
Information provided by:
Asan Medical Center
ClinicalTrials.gov Identifier:
NCT00446641
First received: March 12, 2007
Last updated: December 10, 2009
Last verified: November 2009
  Purpose

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

[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
  Eligibility

Ages Eligible for Study:   35 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00446641

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

No publications provided

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
Cilostazol
Aspirin Resistance

Additional relevant MeSH terms:
Cerebral Infarction
Stroke
Infarction
Brain Infarction
Brain Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Ischemia
Pathologic Processes
Necrosis
Aspirin
Cilostazol
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents

ClinicalTrials.gov processed this record on July 22, 2014