The Comparison of Effects Between Increased Dose of Clopidogrel and Addition of Cilostazol "4C-DES"

Completed

Phase N/A Results N/A

Trial Description

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

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.

Conditions

Interventions

  • Aspirin (stroke prevention) Drug
    Intervention Desc: Antiplatelet agent; inhibits thromboxane A2
  • Clopidogrel (Plavix┬«)Drug
    Other Names: Plavix
    Intervention Desc: Antiplatelet agent
  • Cilostazol (Pletal┬«)Drug
    Other Names: Claudiasil
    Intervention Desc: Anti-platelet agent, possible vasodilator. Phosphodiesterase III inhibitor.
  • Aspirin, clopidogrel Drug
    Other Names: Plavix
    Intervention Desc: aspirin 100 mg plus clopidogrel 150mg qd
    ARM 1: Kind: Experimental
    Label: A
    Description: Aspirin plus increasing clopidogrel group
  • Aspirin, clopidogrel, cilostazol Drug
    Intervention Desc: aspirin 100mg qd,clopidogrel 75mg qd plus cilostazol 100mg bid
    ARM 1: Kind: Experimental
    Label: B
    Description: Aspirin, clopidogrel plus cilostazol group

Trial Design

  • Allocation: Randomized
  • Masking: Open Label
  • Purpose: Treatment
  • Endpoint: Efficacy Study
  • Intervention: Parallel Assignment

Patient Involvement

After the insertion of drug-eluting stent in patients with clopidogrel resistance, patient will be randomized to one of two arms: aspirin 100 mg plus clopidogrel 150mg qd or aspirin 100mg qd,clopidogrel 75mg qd plus cilostazol 100mg bid. Patient will have blood work after 4 weeks to look at drug levels and platelet function.

Outcomes

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

Sponsors