The Comparison of Effects Between Increased Dose of Clopidogrel and Addition of Cilostazol - Full Text View

Sponsored by:	Samsung Medical Center
Information provided by:	Samsung Medical Center
ClinicalTrials.gov Identifier:	NCT00620646

Purpose

To compare the effect of increased dosing of clopidogrel and adding cilostazol to standard dose of clopidogrel after the insertion of drug-eluting stent in patients with clopidogrel resistance

Condition	Intervention
Clopidogrel Non-Responsiveness	Drug: aspirin, clopidogrel Drug: aspirin, clopidogrel, cilostazol

Drug Information available for: Acetylsalicylic acid Clopidogrel Clopidogrel Bisulfate Cilostazol

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	The Comparison of Effects Between Increased Dose of Clopidogrel and Addition of Cilostazol in Clopidogrel Non-Responders After Drug-Eluting Stent Implantation

Further study details as provided by Samsung Medical Center:

Primary Outcome Measures:

% platelet inhibition with VeryfyNow-P2Y12 assay, platelet function test [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

P2Y12 reaction unit (PRU) [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	80
Study Start Date:	February 2008
Estimated Study Completion Date:	December 2008
Estimated Primary Completion Date:	October 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental Aspirin plus increasing clopidogrel group	Drug: aspirin, clopidogrel aspirin 100 mg plus clopidogrel 150mg qd
B: Experimental Aspirin, clopidogrel plus cilostazol group	Drug: aspirin, clopidogrel, cilostazol aspirin 100mg qd,clopidogrel 75mg qd plus cilostazol 100mg bid

Detailed Description:

Using dual antiplatelet agents with aspirin and clopidogrel is essential after drug-eluting stent implantation to prevent restenosis and stent thrombosis. However, variable platelet response and potential resistance to therapy have emerged with clopidogrel. Several studies showed that clopidogrel resistance is associated with increased cardiovascular events after coronary interventions. New antiplatelet therapeutic strategy of is needed in case of clopidogrel resistance. We started this study to compare the effect of double dosing of clopidogrel to 150mg per day and adding cilostazol to standard dose of clopidogrel after the insertion of drug-eluting stent in patients with clopidogrel resistance.

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patient with clopidogrel resistance with treatment of dual antiplatelet agent, aspirin and clopidogrel, for more than 4 weeks after drug-eluting stent
Clopidogrel resistance is defined as a patients with platelet inhibition less than 30% in platelet function test(VerifyNow-P2Y12 assayTM, Accumetrics, San Diego, CA, USA)

Exclusion Criteria:

Acute myocardial infarction within 2 weeks
Unstable angina within 2 weeks
History of using glycoprotein IIb/IIIa inhibitor within 1 month
Cerebral infarction within 3 months
Bleeding diathesis like coagulation disorder, thrombocytopenia (platelet count < 100,000/uL)
history of gastrointestinal bleeding or genitourinary bleeding within 3 months
needed oral anticoagulation
aspirin, clopidogrel or cilostazol hypersensitivity
congestive heart failure
serum creatinine level >2mg/dl
malignancy
using cytochrome P450 inhibitor (eg, itraconazole)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00620646

Contacts

Contact: Hyeon-Cheol Gwon, MD,PhD	82-2-3410-3418	hcgwon@smc.samsung.co.kr
Contact: Joo-Yong Hahn, MD, PhD	82-2-3410-3419	jyhahn@medimail.co.kr

Locations

Korea, Republic of
Samsung Medical Center	Recruiting
Seoul, Korea, Republic of, 135-710
Contact: Hyeon-Cheol Gwon, Professor 82234103419 hc.gwon@samsung.com

Sponsors and Collaborators

Samsung Medical Center

Investigators

Principal Investigator:

Hyeon-Cheol Gwon, MD, PhD

Samsung Medical Center

More Information

Responsible Party:	Samsung Medical Center ( HC Gwon )
Study ID Numbers:	2006-12-026-001
Study First Received:	January 27, 2008
Last Updated:	February 10, 2008
ClinicalTrials.gov Identifier:	NCT00620646
Health Authority:	South Korea: Institutional Review Board

Keywords provided by Samsung Medical Center:

clopidogrel
platelets
percutaneous coronary intervention

Study placed in the following topic categories:

Cilostazol
Aspirin
Clopidogrel

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
Sensory System Agents
Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
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