Overcome Biochemical Aspirin Resistane Through Cilostazol Combination - Full Text View

Sponsors and Collaborators:	Asan Medical Center 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 Ultegra Rapid Platelet Function Assay-ASA.

Condition	Intervention	Phase
Cerebral Infarction	Drug: Cilostazol	Phase IV

Drug Information available for: Acetylsalicylic acid Cilostazol

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, 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

Further study details as provided by Asan Medical Center:

Primary Outcome Measures:

Rate of patients with aspirin reaction units (ARUs) values ≥550 on the Ultegra Rapid Platelet Function Assay-ASA

Secondary Outcome Measures:

Rate of patients with ARUs values ≥500 on the Ultegra Rapid Platelet Function Assay-ASA; ARUs values;
Bleeding time (BT);
Fatal or major bleeding complications;
Any bleeding complications

Estimated Enrollment:	316
Study Start Date:	March 2007
Estimated Study Completion Date:	October 2007

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:

• Rate of patients with aspirin reaction units (ARUs) values ≥550 on the Ultegra Rapid Platelet Function Assay-ASA

Secondary outcome variables:

Rate of patients with ARUs values ≥500 on the Ultegra 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

Contacts

Contact: Sun U Kwon, MD. PhD.	82-2-3010-3960	sunuck@amc.seoul.kr
Contact: Lee Ju-Hun, MD.	82-2-2224-2695	leejuhun@hallym.or.kr

Locations

Korea, Republic of
Asan Medical Center	Recruiting
Seoul, Korea, Republic of, 138-736
Contact: Sun U. Kwon, MD, PhD 82-2-3010-3960 sunuck@amc.seoul.kr
Kangdong Sacred Heart Hospital, Hallym University	Recruiting
SEOUL, Korea, Republic of, 134-701
Contact: Ju-Hun Lee 82-2-2224-2695 leeforte@medimail.co.kr
Eulji University Hospital	Not yet recruiting
Daejon, Korea, Republic of, 302-799
Contact: Soo Joo Lee, MD 82-42-611-3431 sjoolee@eulji.ac.kr
Jae-Kwan Cha	Not yet recruiting
Busan, Korea, Republic of, 602-715
Contact: Jae-Kwan Cha, MD, PhD 82-51-2405266 nrcjk@unitel.co.kr

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

Study ID Numbers:	ARCC
Study First Received:	March 12, 2007
Last Updated:	March 12, 2007
ClinicalTrials.gov Identifier:	NCT00446641
Health Authority:	Korea: Food and Drug Administration

Keywords provided by Asan Medical Center:

Infarction, Cerebral
Cilostazol
Aspirin Resistance

Study placed in the following topic categories:

Cilostazol
Cerebral Infarction
Stroke
Vascular Diseases
Central Nervous System Diseases
Ischemia
Brain Diseases

Cerebrovascular Disorders
Necrosis
Aspirin
Brain Ischemia
Brain Infarction
Infarction

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Respiratory System Agents
Vasodilator Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Hematologic Agents
Fibrinolytic Agents
Neuroprotective Agents
Fibrin Modulating Agents
Pathologic Processes
Sensory System Agents
Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal
Cardiovascular Diseases
Analgesics

Nervous System Diseases
Cyclooxygenase Inhibitors
Anti-Asthmatic Agents
Enzyme Inhibitors
Cardiovascular Agents
Protective Agents
Pharmacologic Actions
Phosphodiesterase Inhibitors
Analgesics, Non-Narcotic
Autonomic Agents
Platelet Aggregation Inhibitors
Peripheral Nervous System Agents
Antirheumatic Agents
Central Nervous System Agents
Bronchodilator Agents

ClinicalTrials.gov processed this record on January 16, 2009