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首页> 外文期刊>Trials >Platelet inhibition during ticagrelor monotherapy versus ticagrelor plus aspirin in patients with coronary artery disease (TEMPLATE study): study protocol for a randomised controlled trial
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Platelet inhibition during ticagrelor monotherapy versus ticagrelor plus aspirin in patients with coronary artery disease (TEMPLATE study): study protocol for a randomised controlled trial

机译：替格瑞洛单药治疗与替格瑞洛加阿司匹林对冠心病患者的血小板抑制作用（TEMPLATE研究）：一项随机对照试验的研究方案

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Dual antiplatelet therapy (DAPT) with aspirin (ASP) and a P2Y12 blocker is currently standard care after percutaneous coronary intervention (PCI) with stent insertion, and aims to inhibit platelet function in order to prevent stent thrombosis. The P2Y12 blocker ticagrelor (TIC) has greater antiplatelet effect than the previously used members of this class, such as clopidogrel. In healthy volunteers, TIC is sufficient to cause strong platelet inhibition, with little additional effect from ASP. Omission of ASP may improve the safety of antiplatelet regimes by reducing bleeding. However, the effect of single antiplatelet treatment with TIC, compared to DAPT with TIC?+?ASP, has not been studied in detail in patients with coronary artery disease. To compare TIC with TIC?+?ASP, we have initiated a single centre, open-label randomised controlled trial (TEMPLATE study) in adults receiving DAPT following PCI with a sample size of 110 patients. Patients are invited to join the study when, as part of standard care, they are due to switch from DAPT (ASP?+?any P2Y12 blocker) to single antiplatelet treatment with ASP alone after 6–12 months. Patients are randomised to receive either TIC or TIC?+?ASP for 4?weeks. All patients then revert to standard care with ASP alone. Blood samples and clinical data are collected at three study visits: at baseline during treatment with ASP?+?any P2Y12 blocker (visit 1); approximately 4?weeks after visit 1 during treatment with either TIC or TIC?+?ASP (visit 2); and approximately 8?weeks after visit 1 when treatment has reverted to ASP alone (visit 3). The primary outcome is the extent of platelet inhibition, measured by light transmission aggregation, flow cytometry, flow chamber and plasma biomarker tests. The primary analysis will compare the extent of platelet inhibition between the TIC and TIC?+?ASP groups at visit 2, adjusted for baseline platelet reactivity. Secondary analyses will compare the extent of platelet inhibition at visit 2 with that at visit 3. This is the first study to compare in detail the extent of platelet inhibition in patients who are receiving TIC compared with TIC?+?ASP. The study findings will complement larger-scale trials of the clinical efficacy and safety of TIC compared to TIC?+?ASP. ISRCTN registry, identifier ISRCTN84335288 . Registered on 23 June 2014.
机译：阿司匹林（ASP）和P2Y12阻滞剂双重抗血小板治疗（DAPT）是目前经支架置入的经皮冠状动脉介入治疗（PCI）后的标准护理，旨在抑制血小板功能以防止支架血栓形成。 P2Y12阻断剂替卡格雷（TIC）具有比以前使用的此类氯吡格雷成员更大的抗血小板作用。在健康志愿者中，TIC足以引起强烈的血小板抑制作用，而ASP几乎没有其他作用。省略ASP可以通过减少出血来提高抗血小板方案的安全性。但是，与冠心病患者相比，与TIC？+？ASP的DAPT相比，使用TIC的单抗血小板治疗的效果尚未得到详细研究。为了将TIC与TIC？+？ASP进行比较，我们启动了一项单中心，开放标签的随机对照试验（TEMPLATE研究），该试验在PCI后接受DAPT的成年人中进行，样本量为110名患者。当作为标准护理的一部分，患者应在6至12个月后从DAPT（ASP？+任何P2Y12阻滞剂）转为单独使用ASP的单一抗血小板治疗时，被邀请参加研究。患者随机接受TIC或TIC？+？ASP治疗4周。然后，所有患者仅使用ASP即可恢复标准护理。在三个研究访问中收集了血液样本和临床数据：ASP？+？P2Y12阻滞剂治疗期间的基线（访问1）; TIC或TIC？+？ASP治疗期间，访视1后约4周（访问2）;在第1次就诊后约8周时，治疗已恢复为仅使用ASP（第3次就诊）。主要结果是通过光透射聚集，流式细胞仪，流室和血浆生物标志物测试测量的血小板抑制程度。初步分析将比较在第2次就基线血小板反应性进行调整后的TIC和TICα+βASP组之间的血小板抑制程度。二级分析将比较访视2和访视3的血小板抑制程度。这是第一个详细比较接受TIC和TIC？+？ASP的患者的血小板抑制程度的研究。与TIC？+？ASP相比，该研究结果将补充TIC的临床疗效和安全性的大规模试验。 ISRCTN注册中心，标识符ISRCTN84335288。 2014年6月23日注册。

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