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

December 14, 2009 updated by: Bursa Postgraduate Hospital
Continuing high dose clopidogrel treatment after elective PCI decreased adverse cardiac events in patients with clopidogrel resistance

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

192

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Bursa, Turkey, 16320
        • Bursa Yüksek İhtisas Eğitim Ve Araştırma Hastanesi

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: high dose clopidogrel
Drug: Clopidogrel
high dose clopidogrel continuing after percutaneous coronary intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Death, MI, TVR revascularization, stroke (MACCE) within 30 days and 6 moths
Time Frame: 6 months.
6 months.

Secondary Outcome Measures

Outcome Measure
Time 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.
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bursa Postgraduate Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2008

Primary Completion (Actual)

July 1, 2009

Study Completion (Actual)

December 1, 2009

Study Registration Dates

First Submitted

December 14, 2009

First Submitted That Met QC Criteria

December 14, 2009

First Posted (Estimate)

December 15, 2009

Study Record Updates

Last Update Posted (Estimate)

December 15, 2009

Last Update Submitted That Met QC Criteria

December 14, 2009

Last Verified

August 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BYİEAH2

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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