The EFFect of hIgh Dose ClopIdogrel treatmENT in Patients With Clopidogrel Resistance
- Registration Number
- NCT01032668
- Lead Sponsor
- Bursa Postgraduate Hospital
- Brief 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 192
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description high dose clopidogrel Clopidogrel -
- Primary Outcome Measures
Name Time Method Death, MI, TVR revascularization, stroke (MACCE) within 30 days and 6 moths 6 months.
- Secondary Outcome Measures
Name Time Method Major or minor bleeding according to TIMI criteria 30 days and 6 months To evaluate the clinical effect of VerifyNow which use as a clopidogrel resistance kit 30 days and 6 months. 6 months
Trial Locations
- Locations (1)
Bursa Yüksek İhtisas Eğitim ve Araştırma Hastanesi
🇹🇷Bursa, Turkey