Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 5:53 PM
Ignite Modification Date:
2025-12-24 @ 5:53 PM
NCT ID:
NCT01032668
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.
Study:
NCT01032668
Study Brief:
Protocol Section:
NCT01032668