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| Name | Class |
|---|---|
| European Cardiovascular Research Center | NETWORK |
| Allies in Cardiovascular Trials Initiatives and Organized | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| [*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 | ||
| [*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 |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Difference in MACCE between responder + compliant patients vs responders + non compliant patients vs non responder patients. | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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STEMI patients treated within the first 24 hours following the first chest pain by Primary PCI (with stent implantation)
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| Name | Affiliation | Role |
|---|---|---|
| Bernard Chevalier | Hopital Privé Jacques Cartier | Principal Investigator |
| Gilles Montalescot | Assistance Publique - Hôpitaux de Paris | Principal Investigator |
| Loïc Belle | Centre Hospitalier de la région Annecienne | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitalier de la Région Annecienne | Annecy | France | ||||
| Hôpital Albert Schweitzer |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32139220 | Derived | 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. |
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DNA Samples from saliva to observe CYP2C19 genetic variants
| Colmar |
| 68003 |
| France |
| Centre Hospitalier Sud Francilien | Corbeil-Essonnes | France |
| Centre Hospitalier d'Haguenau | Haguenau | France |
| Centre Hospitalier Saint Joseph et Saint Luc | Lyon | 69007 | France |
| Hôpital Privé Jacques Cartier | Massy | 91300 | 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 |
| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| D054058 | Acute Coronary Syndrome |
| D010349 | Patient Compliance |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D010342 | Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |
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