Optimal P2Y12-receptor treatmeNt Guided by bedSIDe Genetic or Pharmacodynamic TESTing to Prevent Periprocedural Myonecrosis During Elective Percutaneous Coronary Intervention.
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 150
- 试验地点
- 4
- 主要终点
- Prevalence of periprocedural myocardial injury within 24 h after PCI
研究概览
简要总结
Patients undergoing percutaneous coronary intervention with a residual high platelet reactivity despite oral clopidogrel are at increased risk of ischaemic complications. The strategies to overcome the issue consist of switch to a more potent antiplatelet medications including prasugrel or ticagrelor. Economic constrains of many countries still do not allow wide reimbursement of newer antiplatelet agents. Therefore a strategy to personalise treatment according to genotype and phenotype characteristics of the patient may provide an attractive solution combining high clinical efficacy with low budget impact.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age 18-75
- •elective PCI
排除标准
- •acute coronary syndrome (troponin > 1 x ULN),
- •administration of glycoprotein IIb/IIIa inhibitors,
- •chronic total occlusion,
- •lesions with extensive calcifications requiring rotational atherectomy,
- •platelet count <70 000 /µl
- •high bleeding risk,
- •coronary bypass surgery in the previous 3 months,
- •severe chronic renal failure (eGFR < 30 mL/min)
- •requirement for warfarin, dabigatran, apixaban, rivaroxaban
- •history of stroke or TIA,
- •weight < 60 kg
- •known bleeding diathesis,
- •hematocrit of < 30% or >52%
- •pregnancy
研究组 & 干预措施
Genotyping Arm
Rapid genotyping to select optimal P2Y12-inhibitor for PCI.
干预措施: Genotyping (Device)
Phenotying Arm
The use of platelet function testing to select the optimal P2Y12-inhibitor for PCI.
干预措施: Phenotyping (Device)
Conventional Arm
Regular approach for performing elective PCI.
结局指标
主要结局
Prevalence of periprocedural myocardial injury within 24 h after PCI
时间窗: Within 24 hours after Percutaneous Coronary Intervention (PCI)
Post-procedural troponin value increase exceeding the 99th percentile upper reference limit (URL) within 24 hours after PCI
次要结局
- Proportion of patients having periprocedural myocardial infarction (MI)(Within 24 hours or PCI)
研究者
Łukasz Kołtowski
Cardiology Researcher
Medical University of Warsaw