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

Biotronik

Status: Completed

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

Study type: Observational

Funder types: Other; NETWORK; Industry

Identifiers

NCT01134380

GIANT200905-04

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,500 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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%

Trial design

1,500 participants in 2 patient groups

[*1] Genotype - Good responders to Clopidogrel

Description:

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

Description:

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