How Effective Are Antithrombotic Therapies in Primary Percutaneous Coronary Intervention (HEAT-PPCI)
A Randomised Controlled Trial to Compare Unfractionated Heparin Versus Bivalirudin in the Treatment of Patients With a Clinical Diagnosis of ST-Segment Elevation Myocardial Infarction Events - For Planned Management With Primary PCI
研究概览
详细说明
HEAT-PPCI is a single-centre prospective, dual-arm, open-label, randomised controlled trial comparing two antithrombotic agents in patients undergoing PPCI. All patients presenting to the PPCI service at Liverpool Heart and Chest Hospital will be assessed for trial eligibility. The patients will be allocated by randomisation in equal proportions to the two treatment groups receiving UFH (70 units/kg prior to the procedure) or bivalirudin (bolus of 0.75 mg/kg prior to the start of the intervention, followed by an infusion of 1.75 mg/kg per hour for the duration of the procedure).
Pre-Specified Subgroup Analyses
- Subgroup analyses looking at the impact of access site comparing radial versus femoral route
- Assessment of the outcomes in diabetic patients receiving oral hypoglycaemic or insulin therapy versus all other patients
- Comparing the outcomes in patients < or ≥ 75 years of age
- Type of p2y12 receptor inhibiting antiplatelet agent (Examples: clopidogrel, prasugrel, ticagrelor)
- Patients with impaired LV function versus normal LV function
- Patients managed with actual or attempted primary PCI versus no immediate PCI procedure attempted
PLATELET FUNCTION SUBSTUDY A substudy will be performed to assess indices of coagulation and platelet function studies comparing the impact of heparin or bivalirudin therapy on coagulation status at the end of the PPCI procedure. This study will be performed on all patients treated between the hours of 0800 and 1600, Monday to Friday. A single blood sample taken at the time of general blood sampling for routine clinical screening will be analysed.
研究类型
注册 (实际的)
阶段
- 第四阶段
联系人和位置
学习地点
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Merseyside
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Liverpool、Merseyside、英国、L14 3PE
- Liverpool Heart and Chest Hospital
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- All patients presenting with a suspected myocardial infarction event with PPCI as the proposed index reperfusion strategy will be included in the trial
Exclusion Criteria:
- ≤ 18 years of age
- Known intolerance, hypersensitivity or contraindication to any trial medication
- Active bleeding at presentation
- Artificial ventilation, reduced conscious level or other factors precluding the administration of oral antiplatelet therapy
- Previous enrolment in this trial
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
---|---|
有源比较器:Unfractionated heparin
70 units/kg body weight intravenous
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70 units/kg body weight intravenous
其他名称:
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有源比较器:bivalirudin
intravenous bolus of 0.75 mg/kg followed by infusion of 1.75 mg/kg per hour
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intravenous bolus of 0.75 mg/kg followed by infusion of 1.75 mg/kg per hour
其他名称:
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研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
---|---|
Major Adverse Cardiac Events (MACE) in Terms of the Incidence of All Cause Mortality, Cerebrovascular Accident, Re-infarction and Additional Unplanned Target Lesion Revascularization
大体时间:28 days
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28 days
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Type 3-5 Bleeding According to BARC (Bleeding Academic Research Consortium)Definition
大体时间:28 days
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28 days
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次要结果测量
结果测量 |
大体时间 |
---|---|
全因死亡率
大体时间:1年
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1年
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CKMB Release Following Index Revascularisation Measured With a Single Estimation 12-18 Hours After the Procedure
大体时间:28 days
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28 days
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Minor Bleeding: Type 2 Bleeding According to BARC (Bleeding Academic Research Consortium) Definition
大体时间:28 days
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28 days
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Stent Thrombosis Rate (ARC Definite or Probable)
大体时间:28 days
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28 days
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For Illustration, and to Allow Comparison With Existing Trials the Rate of Net Adverse Clinical Events (NACE), Combining the Primary Safety and Efficacy Outcomes
大体时间:28 days
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28 days
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Development of Thrombocytopenia
大体时间:28 days
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28 days
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Door-to-first Device Time
大体时间:28 days
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28 days
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合作者和调查者
调查人员
- 首席研究员:Rod Stables, MA DM FRCP、Liverpool Heart and Chest Hospital, Liverpool, UK
出版物和有用的链接
一般刊物
- Shahzad A, Kemp I, Mars C, Wilson K, Roome C, Cooper R, Andron M, Appleby C, Fisher M, Khand A, Kunadian B, Mills JD, Morris JL, Morrison WL, Munir S, Palmer ND, Perry RA, Ramsdale DR, Velavan P, Stables RH; HEAT-PPCI trial investigators. Unfractionated heparin versus bivalirudin in primary percutaneous coronary intervention (HEAT-PPCI): an open-label, single centre, randomised controlled trial. Lancet. 2014 Nov 22;384(9957):1849-1858. doi: 10.1016/S0140-6736(14)60924-7. Epub 2014 Jul 4. Erratum In: Lancet. 2014 Nov 22;384(9957):1848.
- Malik N, Gershlick AH. The clinical and economic impact of bivalirudin for percutaneous coronary intervention. Expert Rev Pharmacoecon Outcomes Res. 2013 Dec;13(6):699-706. doi: 10.1586/14737167.2013.844650.
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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