Rationale and design of the Cangrelor versus standard therapy to acHieve optimal Management of Platelet InhibitiON PHOENIX trial
Rationale and design of the Cangrelor versus standard therapy to acHieve optimal Management of Platelet InhibitiON PHOENIX trial
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DOI：
10.1016/j.ahj.2012.02.018
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发表时间：
2012-05-01
影响因子：
4.8
通讯作者：
Bhatt, Deepak L.
中科院分区：
文献类型：
--
作者：
Leonardi, Sergio;Mahaffey, Kenneth W.;Bhatt, Deepak L.
背景 尽管目前的 P2Y(12) 抑制剂在减少需要经皮冠状动脉介入治疗 (PCI) 的患者缺血事件方面具有强大的功效，但仍存在局限性。特别是，它们需要数小时才能发挥作用，而且只能口服。 Cangrelor 是一种静脉注射、强效、可逆的 P2Y12 抑制剂，具有快速起效和抵消作用。我们设计 CHAMPION PHOENIX 是为了评估坎格瑞洛在接受 PCI 的动脉粥样硬化患者中的有效性和安全性。试验设计 CHAMPION PHOENIX 是一项随机、双盲、双模拟、优效性试验，在约 10,900 名既往未接受过 P2Y12 抑制剂且需要 PCI 的患者中比较了坎格瑞洛与氯吡格雷护理标准，包括稳定型心绞痛和急性冠脉综合征患者（或无 ST 段抬高）。该研究的主要目的是证明，与氯吡格雷相比，坎格雷洛可以降低随机分组后48小时内死亡、心肌梗死（MI）、缺血导致的血运重建或支架血栓形成等复合事件的发生率，且不会出现围手术期过度出血。关键的次要目标是证明坎格雷洛可以降低支架内血栓形成的发生率。心肌梗塞将根据通用 MI 定义进行定义，并采用 PCI 相关（4a 型）MI 的定义。出血将根据心肌梗死溶栓、GUSTO 和出血学术研究联盟 (BARC) 量表进行评估。结论 CHAMPION PHOENIX 可能会在当前治疗策略的背景下确定坎格雷洛在稳定和不稳定冠状动脉疾病范围内需要 PCI 的患者护理中的作用。 （Am Heart J 2012；163：768-776.e2。）
Background Despite robust efficacy in the reduction of ischemic events in patients who require percutaneous coronary intervention (PCI), current P2Y(12) inhibitors have limitations. In particular, they require hours to be effective, and they can only be administered orally. Cangrelor is an intravenous, potent, and reversible P2Y12 inhibitor with fast onset and offset of action. We designed CHAMPION PHOENIX to evaluate the efficacy and safety of cangrelor in patients with atherosclerosis undergoing PCI.Trial Design The CHAMPION PHOENIX is a randomized, double-blind, double-dummy, superiority trial comparing cangrelor with clopidogrel standard of care in approximately 10,900 patients who have not previously received a P2Y12 inhibitor and who require PCI, including patients with stable angina and with acute coronary syndromes (with or without ST-segment elevation). The primary objective of the study is to demonstrate that cangrelor will reduce the incidence of the composite of death, myocardial infarction (MI), ischemia-driven revascularization, or stent thrombosis in the 48 hours after randomization compared with clopidogrel without excessive periprocedural bleeding. The key secondary objective is to demonstrate that cangrelor will reduce the incidence of stent thrombosis. Myocardial infarction will be defined according to the universal MI definition, adapting the definition of PCI-related (type 4a) MI. Bleeding will be assessed according to the thrombolysis in myocardial infarction, GUSTO, and Bleeding Academic Research Consortium (BARC) scales.Conclusion The CHAMPION PHOENIX may establish the role of cangrelor in the care of patients who require PCI across the spectrum of stable and unstable coronary diseases in the setting of current treatment strategies. (Am Heart J 2012;163:768-776.e2.)