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

Coronary Artery Disease Clinical Trial

Status Completed

Clinical Trial Summary

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

Clinical Trial Description

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. ;

Study Design

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

• NCT number: NCT01032668
• Study type: Interventional
• Source: Bursa Postgraduate Hospital
• Status: Completed
• Phase: Phase 3
• Start date: September 2008
• Completion date: December 2009