Clinical Drug Experience Knowledgebase

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.