The EFFect of hIgh Dose ClopIdogrel treatmENT in Patients With Clopidogrel Resistance

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

Detailed Description
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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.

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Drug: Clopidogrel


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: high dose clopidogrel<br> | Drug: Clopidogrel<br>* high dose clopidogrel continuing after percutaneous coronary intervention<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Death, MI, TVR revascularization, stroke (MACCE) within 30 days and 6 moths |  | 6 months. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major or minor bleeding according to TIMI criteria 30 days and 6 months To evaluate the clinical effect of VerifyNow which use as a clopidogrel resistance kit 30 days and 6 months. |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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percutaneous coronary intervention, clopidogrel resistance, ASA resistance