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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01134380
Recruitment Status : Completed
First Posted : June 2, 2010
Last Update Posted : October 8, 2014
Information provided by:

Study Description
Brief Summary:
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.

Condition or disease Phase
Coronary Artery Disease Acute Coronary Syndrome Genetic Resistance to Clopidogrel Compliance to Thienopyridine Treatment Phase 4

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 Design

Study Type : Observational
Estimated Enrollment : 1500 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Genotyping Infarct Patients to Adjust and Normalize Thienopyridine Treatment
Study Start Date : June 2010
Primary Completion Date : March 2013
Study Completion Date : March 2013
Groups and Cohorts

[*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

Outcome Measures

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Difference in MACCE between responder + compliant patients vs responders + non compliant patients vs non responder patients. [ Time Frame: 12 months ]

Biospecimen Retention:   Samples With DNA
DNA Samples from saliva to observe CYP2C19 genetic variants

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

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%
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01134380

Centre Hospitalier de la Région Annecienne
Annecy, France
Hôpital Albert Schweitzer
Colmar, France, 68003
Centre Hospitalier Sud Francilien
Corbeil Essonnes, France
Centre Hospitalier d'Haguenau
Haguenau, France
Centre Hospitalier Saint Joseph et Saint Luc
Lyon, France, 69007
Hôpital Privé Jacques Cartier
Massy, France, 91300
Hôpital Bon Secours
Metz, France
Hôpital Arnaud de Villeneuve
Montpellier, France
Centre Hospitalier Universitaire Caremeau
Nîmes, France
Groupe Hospitalier Pitié Salpêtrière
Paris, France
Centre Hospitalier Rene Dubos
Pontoise, France
CHI de Villeneuve
Villeneuve Saint Georges, France
Sponsors and Collaborators
Biotronik France
European Cardiovascular Research Center
Allies in Cardiovascular Trials Initiatives and Organized
Principal Investigator: Bernard Chevalier Hopital Privé Jacques Cartier
Principal Investigator: Gilles Montalescot Assistance Publique - Hôpitaux de Paris
Principal Investigator: Loïc Belle Centre Hospitalier de la région Annecienne
More Information

Responsible Party: Virginie COLIN, Biotronik France
ClinicalTrials.gov Identifier: NCT01134380     History of Changes
Other Study ID Numbers: GIANT200905-04
First Posted: June 2, 2010    Key Record Dates
Last Update Posted: October 8, 2014
Last Verified: July 2011

Keywords provided by Biotronik France:
Percutaneous coronary intervention
Acute coronary syndrome
Dual antiplatelet therapy

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Acute Coronary Syndrome
Heart Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases
Platelet Aggregation Inhibitors
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs