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

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.