DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



The Comparison of Effects Between Increased Dose of Clopidogrel and Addition of Cilostazol

Information source: Samsung Medical Center
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Clopidogrel Non-Responsiveness

Intervention: aspirin, clopidogrel (Drug); aspirin, clopidogrel, cilostazol (Drug)

Phase: N/A

Status: Completed

Sponsored by: Samsung Medical Center

Official(s) and/or principal investigator(s):
Hyeon-Cheol Gwon, MD, PhD, Principal Investigator, Affiliation: Samsung Medical Center

Summary

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

Clinical Details

Official title: The Comparison of Effects Between Increased Dose of Clopidogrel and Addition of Cilostazol in Clopidogrel Non-Responders After Drug-Eluting Stent Implantation

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: % platelet inhibition with VeryfyNow-P2Y12 assay, platelet function test

Secondary outcome: P2Y12 reaction unit (PRU)

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

Minimum age: N/A. Maximum age: N/A. Gender(s): Both.

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)

Locations and Contacts

Samsung Medical Center, Seoul 135-710, Korea, Republic of
Additional Information

Starting date: February 2008
Last updated: February 11, 2009

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017