Clinical trial NCT01134380: Genotyping Infarct Patients to Adjust and Normalize Thienopyridine Treatment
Official title: Genotyping Infarct Patients to Adjust and Normalize Thienopyridine Treatment
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Artery Disease
Acute Coronary Syndrome
Genetic Resistance to Clopidogrel
Compliance to Thienopyridine Treatment
Keywords: Percutaneous coronary intervention
Acute coronary syndrome
Dual antiplatelet therapy
clopidogrel/prasugrel
genotyping
stent
compliance
Lead sponsor: Biotronik France
Sponsor class: INDUSTRY
Collaborators: name: European Cardiovascular Research Center
name: Allies in Cardiovascular Trials Initiatives and Organized
First posted: 2010-06-02
Enrollment: 1500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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)

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.

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 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%

Primary outcomes:
measure: statistical difference in Death, MI and stent thrombosis between genetically resistant patients (*2 genotype) with adapted treatment and non resistant patients (*1 genotype)
timeFrame: 12 months
Secondary outcomes:
measure: Difference in MACCE between responder + compliant patients vs responders + non compliant patients vs non responder patients.
timeFrame: 12 months
Other outcomes:
Locations:
city: Annecy
country: France
facility: Centre Hospitalier de la Région Annecienne
city: Colmar
country: France
facility: Hôpital Albert Schweitzer
city: Corbeil Essonnes
country: France
facility: Centre Hospitalier Sud Francilien
city: Haguenau
country: France
facility: Centre Hospitalier d'Haguenau
city: Lyon
country: France
facility: Centre Hospitalier Saint Joseph et Saint Luc
city: Massy
country: France
facility: Hôpital Privé Jacques Cartier
city: Metz
country: France
facility: Hôpital Bon Secours
city: Montpellier
country: France
facility: Hôpital Arnaud de Villeneuve
city: Nîmes
country: France
facility: Centre Hospitalier Universitaire Caremeau
city: Paris
country: France
facility: Groupe Hospitalier Pitié Salpêtrière
city: Pontoise
country: France
facility: Centre Hospitalier Rene Dubos
city: Villeneuve Saint Georges
country: France
facility: CHI de Villeneuve
Study officials:
affiliation: Hopital Privé Jacques Cartier
name: Bernard Chevalier
role: PRINCIPAL_INVESTIGATOR
affiliation: Assistance Publique - Hôpitaux de Paris
name: Gilles Montalescot
role: PRINCIPAL_INVESTIGATOR
affiliation: Centre Hospitalier de la région Annecienne
name: Loïc Belle
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hulot JS, Chevalier B, Belle L, Cayla G, Khalife K, Funck F, Berthier R, Piot C, Tafflet M, Montalescot G; GIANT Investigators. Routine CYP2C19 Genotyping to Adjust Thienopyridine Treatment After Primary PCI for STEMI: Results of the GIANT Study. JACC Cardiovasc Interv. 2020 Mar 9;13(5):621-630. doi: 10.1016/j.jcin.2020.01.219.