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Continuing high dose clopidogrel treatment after elective PCI decreased adverse cardiac events in patients with clopidogrel resistance
- To evaluate the effect of continuing high dose clopidogrel treatment on adverse cardiac events after elective PCI in patients with clopidogrel resistance
- 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.
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))
- 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%
- 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.
- 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.
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
Published on BioPortfolio: 2014-07-23T21:11:22-0400
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