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

This study has been completed.
Sponsor:
Collaborators:
European Cardiovascular Research Center
ACTION - Allies in Cardiovascular Trials Initiatives and Organized Network
Information provided by:
Biotronik France
ClinicalTrials.gov Identifier:
NCT01134380
First received: May 28, 2010
Last updated: October 7, 2014
Last verified: July 2011
  Purpose

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

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Genotyping Infarct Patients to Adjust and Normalize Thienopyridine Treatment

Resource links provided by NLM:


Further study details as provided by Biotronik France:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Difference in MACCE between responder + compliant patients vs responders + non compliant patients vs non responder patients. [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

DNA Samples from saliva to observe CYP2C19 genetic variants


Estimated Enrollment: 1500
Study Start Date: June 2010
Study Completion Date: March 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Groups/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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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)

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01134380

Locations
France
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
ACTION - Allies in Cardiovascular Trials Initiatives and Organized Network
Investigators
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

No publications provided

Responsible Party: Virginie COLIN, Biotronik France
ClinicalTrials.gov Identifier: NCT01134380     History of Changes
Other Study ID Numbers: GIANT200905-04
Study First Received: May 28, 2010
Last Updated: October 7, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Biotronik France:
Percutaneous coronary intervention
Acute coronary syndrome
Dual antiplatelet therapy
clopidogrel/prasugrel
genotyping
stent
compliance

Additional relevant MeSH terms:
Acute Coronary Syndrome
Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Angina Pectoris
Arterial Occlusive Diseases
Arteriosclerosis
Cardiovascular Diseases
Chest Pain
Heart Diseases
Pain
Signs and Symptoms
Vascular Diseases
Clopidogrel
Hematologic Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Platelet Aggregation Inhibitors
Purinergic Agents
Purinergic Antagonists
Purinergic P2 Receptor Antagonists
Purinergic P2Y Receptor Antagonists
Therapeutic Uses

ClinicalTrials.gov processed this record on September 03, 2015