Overcome Biochemical Aspirin Resistance Through Cilostazol Combination - Full Text View

Sponsor:	Asan Medical Center
Collaborator:	Korea Otsuka Pharmaceutical Co.,Ltd.
Information provided by:	Asan Medical Center
ClinicalTrials.gov Identifier:	NCT00446641

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 IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Phase 4 Study of Additional Cilostazol for Overcoming Biochemical Aspirin Resistance in the Chronic Stroke Patients

Resource links provided by NLM:

Drug Information available for: Acetylsalicylic acid Cilostazol

U.S. FDA Resources

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
1 Cilostazol: Experimental 100mg of Cilostazol twice a day	Drug: Cilostazol cilostazol 100mg twice a day for 4 weeks
Placebo: Placebo Comparator matching placebo to cilostazol	Drug: placebo placebo 1 tablet twice a day matching for 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

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

Locations

Korea, Republic of
Asan Medical Center
Seoul, Korea, Republic of, 138-736
Kangdong Sacred Heart Hospital, Hallym University
Seoul, Korea, Republic of, 134-701
Eulji University Hospital
Daejon, Korea, Republic of, 302-799
Jae-Kwan Cha
Busan, Korea, Republic of, 602-715

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

Keywords provided by Asan Medical Center:

Infarction, Cerebral
Cilostazol
Aspirin Resistance

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Respiratory System Agents
Vasodilator Agents
Molecular Mechanisms of Pharmacological Action
Cerebral Infarction
Hematologic Agents
Physiological Effects of Drugs
Fibrinolytic Agents
Brain Diseases
Neuroprotective Agents
Cerebrovascular Disorders
Fibrin Modulating Agents
Necrosis
Pathologic Processes
Aspirin

Sensory System Agents
Therapeutic Uses
Brain Ischemia
Cardiovascular Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Cilostazol
Cyclooxygenase Inhibitors
Nervous System Diseases
Stroke
Vascular Diseases
Anti-Asthmatic Agents
Central Nervous System Diseases
Enzyme Inhibitors
Cardiovascular Agents

ClinicalTrials.gov processed this record on February 08, 2010