Genotyping Infarct Patients to Adjust and Normalize Thienopyridine Treatment

Coronary Artery Disease Clinical Trial

— GIANT  

Official title:

Genotyping Infarct Patients to Adjust and Normalize Thienopyridine Treatment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01134380
• Other study ID #: GIANT200905-04
• Status: Completed
• Phase: Phase 4
• First received: May 28, 2010
• Last updated: October 7, 2014
• Start date: June 2010
• Est. completion date: March 2013

Study information

• Verified date: July 2011
• Source: Biotronik France
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1500
• Est. completion date: March 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Compliance to Thienopyridine Treatment
• Coronary Artery Disease
• Coronary Disease
• Genetic Resistance to Clopidogrel
• Myocardial Ischemia

Locations

Country	Name	City	State
France	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

Sponsors (3)

Lead Sponsor	Collaborator
Biotronik France	Allies in Cardiovascular Trials Initiatives and Organized, European Cardiovascular Research Center

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Difference in MACCE between responder + compliant patients vs responders + non compliant patients vs non responder patients.		12 months	No