NCT01032668

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 192 (actual)
• Sponsor: Bursa Postgraduate Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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.

Conditions

• Coronary Artery Disease

Interventions

Type	Name	Description
DRUG	Clopidogrel	high dose clopidogrel continuing after percutaneous coronary intervention

Timeline

• Start date: 2008-09-01
• Primary completion: 2009-07-01
• Completion: 2009-12-01
• First posted: 2009-12-15
• Last updated: 2009-12-15

Locations

1 site across 1 country: Turkey (Türkiye)