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:	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:

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
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

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 February 09, 2012