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

Clopidogrel Non-Responsiveness Clinical Trial

— 4C-DES  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00620646
• Other study ID #: 2006-12-026
• Status: Completed
• Phase: N/A
• First received: January 27, 2008
• Last updated: February 11, 2009
• Start date: February 2008
• Est. completion date: February 2009

Study information

• Verified date: February 2009
• Source: Samsung Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: February 2009
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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)

Study Design

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

Related Conditions & MeSH terms

• Clopidogrel Non-Responsiveness

Intervention

Drug:
• aspirin, clopidogrel
aspirin 100 mg plus clopidogrel 150mg qd
• aspirin, clopidogrel, cilostazol
aspirin 100mg qd,clopidogrel 75mg qd plus cilostazol 100mg bid

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	% platelet inhibition with VeryfyNow-P2Y12 assay, platelet function test		4 weeks	No
Secondary	P2Y12 reaction unit (PRU)		4 weeks	No