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

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01032668
Acronym
EFFICIENT
Enrollment
192
Registered
2009-12-15
Start date
2008-09-30
Completion date
2009-12-31
Last updated
2009-12-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Artery Disease

Keywords

percutaneous coronary intervention, clopidogrel resistance, ASA resistance

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.

Interventions

DRUGClopidogrel

high dose clopidogrel continuing after percutaneous coronary intervention

Sponsors

Bursa Postgraduate Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
Death, MI, TVR revascularization, stroke (MACCE) within 30 days and 6 moths6 months.

Secondary

MeasureTime frame
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

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 29, 2026