Evaluation of Myocardial Reperfusion and Residual Thrombotic Burden After Primary PCI for STEMI in Patients With High on Ticagrelor Platelet Reactivity Treated by IV Cangrelor Versus Ticagrelor Alone
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 128
- 试验地点
- 1
- 主要终点
- Grade of myocardial blush
研究概览
简要总结
This study aims to evaluate the impact on myocardial reperfusion and residual thrombotic burden of adding Cangrelor -a potent and immediate P2Y12 inhibitor- to ticagrelor in primary PCI patients with high on ticagrelor platelet reactivity compared to standard of care with ticagrelor alone.
详细描述
Despite the use of potent P2Y12 inhibitor such as ticagrelor, half of the patients presented high platelet reactivity (HPR) at the time of primary percutaneous coronary intervention (PCI) for ST-elevation myocardial infarction (STEMI). HPR has been associated with impaired myocardial reperfusion. Myocardial reperfusion, assessed using myocardial blush grade, is a strong prognostic factor associated with infarct size and mortality. Antiplatelet therapy intensification using a potent and immediate P2Y12 inhibitor such as Cangrelor according a point-of-care platelet function test has not been studied in the acute phase of STEMI.
This study aims to evaluate the impact on myocardial reperfusion and residual thrombotic burden of adding Cangrelor to ticagrelor in primary PCI patients with high on ticagrelor platelet reactivity compared to standard of care with ticagrelor alone.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •patient admitted for STEMI within 24 hours from symptom onset
- •pretreated with ticagrelor, aspirin and enoxaparin (according local protocol)
- •successfully treated by primary PCI of a native coronary culprit lesion
- •anatomy accessible to optical coherence tomography (OCT or OFDI)
排除标准
- •cardiogenic shock
- •stent restenosis or thrombosis
- •use of glycoprotein IIb/IIIa inhibitors before or during PCI
- •known coagulation disease
- •high bleeding risk (thrombocytopenia <100,000/dL, surgery <30 days, active bleeding)
- •uncontrolled arterial hypertension (>180/110 mmHg)
- •history of stroke (ischemic or hemorrhagic) or transient ischemic attack
- •known severe renal insufficiency (eGFR <30 ml/min)
- •oral anticoagulation
研究组 & 干预措施
patients without HPR
standard primary PCI
干预措施: standard PCI (Procedure)
patients with HPR randomized to cangrelor
Cangrelor perfusion started before PCI
干预措施: cangrelor perfusion during PCI (Drug)
patients with HPR randomized to standard of care
standard primary PCI
干预措施: standard PCI (Procedure)
结局指标
主要结局
Grade of myocardial blush
时间窗: during procedure
myocardial blush grade from 0 to 3 (normal)
次要结局
- percentage of residual thrombus burden(during procedure)
- measure of platelet reactivity(during procedure)
- infarct size and no reflow on MRI(during hospitalization assessed up to 7 days)
- clinical outcomes(during hospitalization assessed up to 7 days)
- troponin(day 1)