Genotyping Infarct Patients to Adjust and Normalize Thienopyridine Treatment

NCT01134380 | Completed DMC

• 1 other identifier: GIANT200905-04
• Study Type: observational
• Target: 1,500
• Locations: 1 country
• Sites: 12

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.

Conditions

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

Keywords

Percutaneous coronary intervention; Acute coronary syndrome; Dual antiplatelet therapy; clopidogrel/prasugrel; genotyping; stent; compliance

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

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

  12 months

Study Arms (2)

[*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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

STEMI patients treated within the first 24 hours following the first chest pain by Primary PCI (with stent implantation)

You may qualify if:

• 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

You may not qualify if:

• 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%

Sponsors & Collaborators

• Biotronik France: lead
• European Cardiovascular Research Center: collaborator
• Allies in Cardiovascular Trials Initiatives and Organized: collaborator

Study Sites (12)

Centre Hospitalier de la Région Annecienne

Annecy, France

Location

Hôpital Albert Schweitzer

Colmar, 68003, France

Location

Centre Hospitalier Sud Francilien

Corbeil-Essonnes, France

Location

Centre Hospitalier d'Haguenau

Haguenau, France

Location

Centre Hospitalier Saint Joseph et Saint Luc

Lyon, 69007, France

Location

Hôpital Privé Jacques Cartier

Massy, 91300, France

Location

Hôpital Bon Secours

Metz, France

Location

Hôpital Arnaud de Villeneuve

Montpellier, France

Location

Centre Hospitalier Universitaire Caremeau

Nîmes, France

Location

Groupe Hospitalier Pitié Salpêtrière

Paris, France

Location

Centre Hospitalier Rene Dubos

Pontoise, France

Location

CHI de Villeneuve

Villeneuve-Saint-Georges, France

Location

Related Publications (1)

• 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.

  PMID: 32139220 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

DNA Samples from saliva to observe CYP2C19 genetic variants

MeSH Terms

Conditions

Coronary Artery Disease; Acute Coronary Syndrome; Patient Compliance

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• 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

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: May 28, 2010
• First Posted: June 2, 2010
• Study Start: June 1, 2010
• Primary Completion: March 1, 2013
• Study Completion: March 1, 2013
• Last Updated: October 8, 2014

Record last verified: 2011-07

Locations

FR (12)