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

Bursa Postgraduate Hospital

Status and phase

Completed

Phase 3

Conditions

Coronary Artery Disease

Treatments

Drug: Clopidogrel

Study type

Interventional

Funder types

Other

Identifiers

NCT01032668

BYİEAH2

Details and patient eligibility

About

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

Full 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.

Enrollment

192 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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