Genotyping Infarct Patients to Adjust and Normalize Thienopyridine Treatment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,500
- 试验地点
- 12
- 主要终点
- statistical difference in Death, MI and stent thrombosis between genetically resistant patients (*2 genotype) with adapted treatment and non resistant patients (*1 genotype)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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%
结局指标
主要结局
statistical difference in Death, MI and stent thrombosis between genetically resistant patients (*2 genotype) with adapted treatment and non resistant patients (*1 genotype)
时间窗: 12 months
次要结局
- Difference in MACCE between responder + compliant patients vs responders + non compliant patients vs non responder patients.(12 months)