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

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

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.

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.

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.

Aleil B, Jacquemin L, De Poli F, Zaehringer M, Collet JP, Montalescot G, Cazenave JP, Dickele MC, Monassier JP, Gachet C. Clopidogrel 150 mg/day to overcome low responsiveness in patients undergoing elective percutaneous coronary intervention: results from the VASP-02 (Vasodilator-Stimulated Phosphoprotein-02) randomized study. JACC Cardiovasc Interv. 2008 Dec;1(6):631-8. doi: 10.1016/j.jcin.2008.09.004.

Ari H, Ozkan H, Karacinar A, Ari S, Koca V, Bozat T. The EFFect of hIgh-dose ClopIdogrel treatmENT in patients with clopidogrel resistance (the EFFICIENT trial). Int J Cardiol. 2012 Jun 14;157(3):374-80. doi: 10.1016/j.ijcard.2010.12.083. Epub 2011 Jan 15.