Genotyping Infarct Patients to Adjust and Normalize Thienopyridine Treatment

NCT ID: NCT01134380

Last Updated: 2014-10-08

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 1500 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2010-06-30
• Study Completion Date: 2013-03-31

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.

Conditions

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

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

[*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

No interventions assigned to this group

[*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

No interventions assigned to this group

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%

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

European Cardiovascular Research Center

NETWORK

Sponsor Role: collaborator

Allies in Cardiovascular Trials Initiatives and Organized

OTHER

Sponsor Role: collaborator

Biotronik France

INDUSTRY

Sponsor Role: lead

Responsible Party

Biotronik France

Principal Investigators

Bernard Chevalier

Role: PRINCIPAL_INVESTIGATOR

Hopital Privé Jacques Cartier

Gilles Montalescot

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

Loïc Belle

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier de la région Annecienne

Locations

Centre Hospitalier de la Région Annecienne

Annecy, , France

Hôpital Albert Schweitzer

Colmar, , France

Centre Hospitalier Sud Francilien

Corbeil-Essonnes, , France

Centre Hospitalier d'Haguenau

Haguenau, , France

Centre Hospitalier Saint Joseph et Saint Luc

Lyon, , France

Hôpital Privé Jacques Cartier

Massy, , France

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

Countries

France

References

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.

Reference Type: DERIVED

PMID: 32139220 (View on PubMed)

Other Identifiers

GIANT200905-04

Identifier Type: -

Identifier Source: org_study_id