Genotyping Infarct Patients to Adjust and Normalize Thienopyridine Treatment

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.

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Key information

Conditions

Coronary Artery Disease Acute Coronary Syndrome Arterial Occlusive Diseases Arteriosclerosis Behavior Cardiovascular Diseases Compliance to Thienopyridine Treatment Coronary Disease Genetic Resistance to Clopidogrel Health Behavior Heart Diseases Myocardial Ischemia Patient Acceptance of Health Care Patient Compliance Treatment Adherence and Compliance Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Centre Hospitalier de la Région Annecienne, Annecy, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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%

Treatment and study plan

Primary outcomes

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

Time frame: 12 months

Secondary outcomes

Difference in MACCE between responder + compliant patients vs responders + non compliant patients vs non responder patients.

Time frame: 12 months

Sponsors and collaborators

Lead sponsor

Biotronik France

Industry

Collaborators

Allies in Cardiovascular Trials Initiatives and Organized
European Cardiovascular Research Center

Registry information

Acronym: GIANT

Important dates

Study start: 2010
Primary completion: 2013
Study completion: 2013
First posted: Jun 2, 2010
Registry last updated: Oct 8, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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