E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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. |
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MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
Main objective of the trial is to evaluate the clinical impact of the genetic profile determination (CYP2C19 Gene) concerning resistance to thienopyridine |
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E.2.2 | Secondary objectives of the trial |
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. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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 |
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E.4 | Principal 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% |
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E.5 End points |
E.5.1 | 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)
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Yes |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 65 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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The end of the trial is defined by the completion of the 12 month follow up visits by all the included patients. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |