Genotyping Infarct Patients to Adjust and Normalize Thienopyridine Treatment (GIANT)

October 7, 2014 updated by: Biotronik France
The objective of GIANT Study is to evaluate the clinical impact of genetic resistance to thienopyridine profile determination (CYP2C19 gene) and the clinical impact of compliance to an adjusted thienopyridine treatment on STEMI patients treated by primary PCI within the 24 hours following the first chest pain.

Study Overview

Status

Completed

Conditions

Detailed Description

All the STEMI patients treated by primary PCI (with stent implantation) within the 24 hours following the first chest pain can be included in the GIANT study. After the PCI, they'll receive DAT (Aspirin + Clopidogrel/Prasugrel).

Patients will then be genotyped to determine if they carry one of the CYP2C19 gene variants making them resistant or hyper responder to clopidogrel. The genetic profile of the patients will be communicated to the physician who took care of them so that he can (or not) adjust the thienopyridine treatment (increase of the clopidogrel dosage, switch to prasugrel or switch to clopidogrel). A treatment will be prescribed for 12 months as according to the European guidelines.

One year after the PCI, the patients will have to be available for a follow up visit. They'll be submitted to a VERIFY NOW P2Y12 protocol to determine whether they were compliant to their thienopyridine treatment. A clinical follow up will be also performed to evaluate the cardiovascular events.

Study Type

Observational

Enrollment (Anticipated)

1500

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

  • France
      • Annecy, France
        • Centre Hospitalier de la Région Annecienne
      • Colmar, France, 68003
        • Hôpital Albert Schweitzer
      • Corbeil Essonnes, France
        • Centre Hospitalier Sud Francilien
      • Haguenau, France
        • Centre Hospitalier d'Haguenau
      • Lyon, France, 69007
        • Centre Hospitalier Saint Joseph Et Saint Luc
      • Massy, France, 91300
        • Hôpital Privé Jacques Cartier
      • Metz, France
        • Hôpital Bon Secours
      • Montpellier, France
        • Hopital Arnaud de Villeneuve
      • Nîmes, France
        • Centre Hospitalier Universitaire Caremeau
      • Paris, France
        • Groupe Hospitalier Pitié Salpêtrière
      • Pontoise, France
        • Centre Hospitalier Rene Dubos
      • Villeneuve Saint Georges, France
        • CHI de Villeneuve

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

STEMI patients treated within the first 24 hours following the first chest pain by Primary PCI (with stent implantation)

Description

Inclusion Criteria:

  • STEMI patient treated within the first 24 hours with primary PCI (with stent implantation)
  • Age superior or equal to 18 years old
  • Informed consent signed
  • Patient volunteer to be submitted to the 1 year visit follow up and to the clinical exams during this visit
  • Patient benefiting from French social health system

Exclusion Criteria:

  • NONSTEMI patient with high troponin
  • STEMI patient treated after the first 24 hours
  • Stable / unstable angina or silent ischemia
  • Cardiogenic shock
  • Oral anticoagulation (Vitamin K Antagonists)
  • Contraindication for PCI
  • Age inferior to 18 years old
  • Life expectancy inferior to 1 year
  • Participation in another clinical trial
  • No signed informed consent
  • Patient not available for the 1 year visit follow up
  • Pregnant women
  • Known allergy to media contrast that can not be controlled by an adapted treatment
  • Known allergy to cobalt chromium alloy
  • Left ventricular ejection fraction lower than 30%

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

Cohorts and Interventions

Group / Cohort
[*1] Genotype - Good responders to Clopidogrel
This group of patients is defined thanks to the DNA extracted from their saliva: [*1] genotype patients are good responders to clopidogrel
[*2] genotype with adapted thienopyridine treatment
This group of patients is defined thanks to the DNA extracted from their saliva: [*2] genotype patients are bad responders to clopidogrel and their thienopyridine treatment has been adapted

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
statistical difference in Death, MI and stent thrombosis between genetically resistant patients (*2 genotype) with adapted treatment and non resistant patients (*1 genotype)
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Difference in MACCE between responder + compliant patients vs responders + non compliant patients vs non responder patients.
Time Frame: 12 months
12 months

Collaborators and Investigators

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

Sponsor

Biotronik France

Collaborators

European Cardiovascular Research Center
Allies in Cardiovascular Trials Initiatives and Organized

Investigators

  • Principal Investigator: Bernard Chevalier, Hôpital Privé Jacques Cartier
  • Principal Investigator: Gilles Montalescot, Assistance Publique - Hôpitaux de Paris
  • Principal Investigator: Loïc Belle, Centre Hospitalier de la Région Annecienne

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

June 1, 2010

Primary Completion (Actual)

March 1, 2013

Study Completion (Actual)

March 1, 2013

Study Registration Dates

First Submitted

May 28, 2010

First Submitted That Met QC Criteria

June 1, 2010

First Posted (Estimate)

June 2, 2010

Study Record Updates

Last Update Posted (Estimate)

October 8, 2014

Last Update Submitted That Met QC Criteria

October 7, 2014

Last Verified

July 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GIANT200905-04

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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