Genotyping Infarct Patients to Adjust and Normalize Thienopyridine Treatment

Completed

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

• Registration Number: NCT01134380
• Lead Sponsor: Biotronik France

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.

Study Timeline

• Study First Submitted: 2010-05-28
• Study Start: 2010-06
• Study First Submitted QC: 2010-06-01
• Study First Posted: 2010-06-02
• Status Verified: 2011-07
• Primary Completion: 2013-03
• Study Completion: 2013-03
• Last Update Submitted: 2014-10-07
• Last Update Posted: 2014-10-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1500

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%

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
statistical difference in Death, MI and stent thrombosis between genetically resistant patients (*2 genotype) with adapted treatment and non resistant patients (*1 genotype)	12 months

Secondary Outcome Measures

Name	Time	Method
Difference in MACCE between responder + compliant patients vs responders + non compliant patients vs non responder patients.	12 months

Trial Locations

Locations (12)

Centre Hospitalier de la Région Annecienne; 🇫🇷 Annecy, 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

Hôpital Albert Schweitzer; 🇫🇷 Colmar, France

Centre Hospitalier Sud Francilien; 🇫🇷 Corbeil Essonnes, France

Centre Hospitalier Universitaire Caremeau; 🇫🇷 Nîmes, France

Groupe Hospitalier Pitié Salpêtrière; 🇫🇷 Paris, France

Centre Hospitalier d'Haguenau; 🇫🇷 Haguenau, France

Centre Hospitalier Rene Dubos; 🇫🇷 Pontoise, France

CHI de Villeneuve; 🇫🇷 Villeneuve Saint Georges, France