The GIANT trial is dedicated to STEMI patients being treated by a primary PCI (with stent implantation) within the 24 hours following the first pain.
Conditions
Interventions
Product Name: thienopyridin
Pharmaceutical Form: Film-coated tablet
Sponsors
BIOTRONIK France
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - STEMI patient treated by primary PCI (with stent implantation) within the 24 hours following first chest pain - age above 18 years old - Informed consent has to be signed by the patient - Patient available to perform the 1year-follow up visit - Patient covered by French Health Care system Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - NONSTEMI patient with high troponin - STEMI patient not treated in the first 24 hours following chest pain - Stable or unstable angina or silent ischemia - Cardiogenic shock - Patient under AVK treatment - Contra-indication for PCI - Age under 18 years old - Participation in another clinical trial - Pregnancy / planification of pregnancy - Known allergy to media contrast that can not be controlled by an adapted treatment - Known allergy to Cobalt Chromium alloy - LVEF < 30%
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Main objective of the trial is to evaluate the clinical impact of the genetic profile determination (CYP2C19 Gene) concerning resistance to thienopyridine ;Secondary Objective: Evaluate the clinical impact of compliance to a thienopyridine treatment, adapted or not, on STEMI patients treated by primary PCI (with stent implantation) within the 24 hours following first chest pain.;Primary end point(s): statistical difference in Death, MI and stent thrombosis at 12 months between genetically resistant patients (*2 genotype) with adapted treatment and non resistant patients (*1 genotype) | — |
Countries
France
Outcome results
None listed