此页面是自动翻译的,不保证翻译的准确性。请参阅 英文版 对于源文本。

Platelet Reactivity and Treatment With Prostacyclin Analogues in Pulmonary Arterial Hypertension (PAPAYA)

2020年10月8日 更新者:Medical University of Warsaw

Background: Prostacyclin analogues (epoprostenol, treprostinil and iloprost) induce vasodilation in advanced pulmonary arterial hypertension (PAH) but also inhibit platelets, increasing patients' bleeding risk. The antiplatelet effects of different prostacyclin analogues have never been compared head-to-head. The goal of the PAPAYA (Platelet Reactivity and Treatment With Prostacyclin Analogues in Pulmonary Arterial Hypertension) trial is(i) to compare platelet function (platelet reactivity, extracellular vesicles concentration and thrombus formation) in patients with PAH treated with prostacyclin analogues on top of endothelin receptor antagonists (ERA) and/or phosphodiesterase type 5 inhibitors (PDE5i) and patients treated only with ERA and PDE5i, and (ii) to compare the antiplatelet effect of different prostacyclin analogues.

Venous blood will be collected from patients treated with prostacyclin analogues (study group; n=40) and patients treated with ERA or PDE5i (control group; n=40). Platelet reactivity will be analysed in whole blood by impedance aggregometry using arachidonic acid, adenosine diphosphate and thrombin receptor-activating peptide as agonists. Concentrations of extracellular vesicles from all platelets (CD61+), activated platelets (CD62P+), leukocytes (CD45+) and endothelial cells (CD146+) will be analysed in platelet-depleted plasma using flow cytometry (A-60 Micro). Platelet-rich thrombus formation will be measured using whole blood perfusion system. The study will determine the antiplatelet effect of prostacyclin analogues and compare different prostacyclin analogues head-to-head to identify the best drugs to use in case of thrombosis or bleeding.

研究概览

地位

完全的

研究类型

观察性的

注册 (实际的)

80

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

      • Warsaw、波兰
        • Department of Pulmonary Circulation, Thromboembolic Diseases and Cardiology, Centre of Postgraduate Education Medical, European Health Centre Otwock

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 99年 (成人、年长者)

接受健康志愿者

不适用

有资格学习的性别

全部

取样方法

概率样本

研究人群

Patients were eligible for enrolment if they (i) had PAH diagnosed according to the criteria of European Society of Cardiology and European Respiratory Society, confirmed during right heart catheterization, (ii) were treated with prostacyclin analogues on top of other drugs (study group) or only other drugs (ERA and PDE-5i; control group) for at least 1 month.

描述

Inclusion Criteria:

  • Informed consent to participate in the study
  • Pulmonary arterial hypertension confirmed with right heart catheterization
  • Treatment with prostacyclin analogues (epoprostenol, treprostinil, iloprost) - study group
  • Treatment with endothelin receptor antagonists and phosphodiesterase type 5 inhibitors - control group

Exclusion Criteria:

  • Known coagulopathy
  • Active pathological bleeding
  • Known history of bleeding disorder
  • Severe thrombocytopenia (platelet count < 50,000/μL )
  • Need for antiplatelet therapy with acetylsalicylic acid or P2Y12 antagonists
  • Severe chronic renal failure (estimated glomerular filtration rate < 30 mL/min)
  • Severe liver insufficiency (Child-Pugh class C)
  • Known pregnancy, breast-feeding, or intention to become pregnant during the study period
  • Study drug intolerance
  • Participation in any previous study with prostacyclin analogues

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

队列和干预

团体/队列
Study group
Patients with pulmonary arterial hypertension treated with prostacyclin analogues on top of ERA or PDE-5i.
Control group
Patients with pulmonary arterial hypertension treated with ERA or PDE-5i only.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Platelet reactivity
大体时间:July 5, 2017 - November 30, 2019
Difference in platelet reactivity between patients treated with prostacyclin analogues and treated with ERA and/ or PDE5-i, assessed using impedance aggregometry
July 5, 2017 - November 30, 2019

次要结果测量

结果测量
措施说明
大体时间
Concentration of extracellular vesicles from platelets, leukocytes and endothelial cells
大体时间:July 5, 2017 - November 30, 2019
Differences in concentration of extracellular vesicles from platelets, leukocytes and endothelial cells between patients treated with prostacyclin analogues and treated with ERA and/ or PDE5i, assessed using flow cytometry
July 5, 2017 - November 30, 2019
Platelet-rich thrombus formation parameters
大体时间:July 5, 2017 - November 30, 2019
Differences in platelet-rich thrombus formation parameters between patients treated with prostacyclin analogues and treated with ERA and/ or PDE5i, assessed using whole-blood flow-chamber perfusion system
July 5, 2017 - November 30, 2019

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2017年7月5日

初级完成 (实际的)

2019年11月30日

研究完成 (实际的)

2020年9月23日

研究注册日期

首次提交

2020年9月30日

首先提交符合 QC 标准的

2020年9月30日

首次发布 (实际的)

2020年10月8日

研究记录更新

最后更新发布 (实际的)

2020年10月9日

上次提交的符合 QC 标准的更新

2020年10月8日

最后验证

2020年9月1日

更多信息

与本研究相关的术语

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

订阅