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

2014-07-23 21:11:22 | BioPortfolio


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



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.

Study Design

Allocation: Randomized, Control: Active Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Coronary Artery Disease




Bursa Yüksek İhtisas Eğitim ve Araştırma Hastanesi




Bursa Postgraduate Hospital

Results (where available)

View Results


Published on BioPortfolio: 2014-07-23T21:11:22-0400

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