The EFFect of hIgh Dose ClopIdogrel treatmENT in Patients With Clopidogrel Resistance
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease
Study type: Interventional
Phase: Phase 3

Summary: 
      Continuing high dose clopidogrel treatment after elective PCI decreased adverse cardiac
      events in patients with clopidogrel resistance
    

Detailed description: 
      Aim:

      Primary objective:

        -  To evaluate the effect of continuing high dose clopidogrel treatment on adverse cardiac
           events after elective PCI in patients with clopidogrel resistance

      Secondary objective:

        -  To evaluate the effect of continuing high dose clopidogrel treatment on adverse cardiac
           events after elective PCI

        -  To evaluate the effect of continuing high dose clopidogrel treatment on bleeding
           complications after elective PCI

        -  To evaluate the clinical effect of VerifyNow which use as a clopidogrel resistance kit.

      Study central:

      Bursa Postgraduate Hospital, Cardiology Clinic

      Study population:

      we planned to enrol 180 patients. 50% of patients without clopidogrel resistance (control
      group: 90 patients) 50% have clopidogrel resistance. Than we randomise the patients (with
      clopidogrel resistance) in two groups (group 1:45 patients (75mg/day), group 2:45 patients
      (150mg/day))

      inclusion criteria:

        -  The patients; who have planned elective PCI and have had written informed consent for
           participation to study.

        -  Age>18 year-old,

        -  The native coronary artery;lesion with narrowing >=70%

      Exclusion criteria:

        -  Patients have allergy for ASA, Clopidogrel and heparin

        -  Patients who performed primary PCI

        -  Patients with acute coronary syndrome

        -  Patients with have a history of PCI and use clopidogrel

        -  Patients on warfarin therapy

        -  Patients who have bleeding diathesis, or have high risk for bleeding.

      Study works:

        -  Write case report form for all patients

        -  Control for inclusion criteria.

        -  Evaluate the clopidogrel and ASA resistance with VerifyNow kit. Than randomised the
           patients.

        -  Demographic data (age, gender)

        -  Height, weight, BMI and GFR

        -  Risk factors

        -  laboratory data (biochemical and hematologic)

        -  Medication history

        -  Echocardiographic data

        -  Angiographic data

        -  PCI data(vessel diameter, stent diameter, lesion and stent length, performed PTCA or
           not, etc)

        -  Note complication (MACE, bleeding, hematoma etc)

           4 weeks later note the first control data and re assess the clopidogrel resistance with
           VerifyNow kit in patients groups 1 and 2.

      Six months later note the second control data.
    

Intervention name(s): Clopidogrel
Intervention type(s): Drug
Intervention description(s): high dose clopidogrel continuing after percutaneous coronary intervention
Intervention MeSH terms: Clopidogrel
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: percutaneous coronary intervention, clopidogrel resistance, ASA resistance