Pharmacodynamic Effects of Prasugrel Compared With Ticagrelor in Patients With Coronary Artery Disease
2015年5月26日 更新者：University of Florida
A head-to Head Comparison of the Pharmacodynamic Effects of Prasugrel Compared With Ticagrelor in Patients With Coronary Artery Disease
Recently, two P2Y12 receptor inhibitors have been approved for clinical use: prasugrel and ticagrelor.
Both prasugrel and ticagrelor have shown to be associated with more potent antiplatelet effects compared with clopidogrel and are associated with an improved net clinical benefit.
However, to date there are limited head-to-head comparisons of these two new agents.
研究概览
详细说明
Dual antiplatelet therapy consisting of aspirin and clopidogrel is the cornerstone of treatment for prevention of thrombotic events in patients with coronary artery disease (CAD) undergoing percutaneous coronary intervention (PCI).
However, there are a considerable number of patients who continue to have recurrent ischemic events despite this treatment regimen.
These observations underscore the need for more potent antiplatelet therapies.
Recently, two P2Y12 receptor inhibitors have been approved for clinical use: prasugrel and ticagrelor.
Both prasugrel and ticagrelor have shown to be associated with more potent antiplatelet effects compared with clopidogrel.
These more favorable pharmacodynamic effects translate into reduced ischemic event rates, at the expense of an increased risk of bleeding in patients with acute coronary syndromes.
Overall, these drugs are associated with an improved net clinical benefit.
These findings from large-scale clinical investigations have led to approval of prasugrel and ticagrelor.
However, to date there are limited head-to-head comparisons of these two new agents.
研究类型
介入性
注册 (实际的)
110
阶段
- 不适用
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
-
-
Florida
-
Jacksonville、Florida、美国、32209
- University of Florida
-
-
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 74年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Patients with known coronary artery disease
- On maintenance treatment with aspirin (81 mg per day) and clopidogrel (75 mg per day) for at least 1-month as per standard of care.
- Age between 18 and 74 years old.
Exclusion Criteria:
- History of stroke, transient ischemic attack or intracranial bleeding.
- Known allergies to aspirin, prasugrel, ticagrelor, or clopidogrel.
- Weight <60kg
- On treatment with oral anticoagulation (coumarin derivate, dabigatran).
- Hemoglobin<10 gm/dL
- Platelet count <80x106/mL
- Active bleeding or hemodynamic instability.
- Creatinine Clearance <30 mL/minute.
- Baseline ALT >2.5 times the upper limit of normal.
- Patients with sick sinus syndrome (SSS) or high degree AV block without pacemaker protection.
- Drugs interfering with 2C19 metabolism (to avoid interaction with clopidogrel): , fluconazole (Diflucan), ketoconazole (Nizoral), voriconazole (VFEND), etravirine (Intelence), felbamate (Felbatol), fluoxetine (Prozac, Serafem, Symbyax), fluvoxamine (Luvox), and ticlopidine (Ticlid).
- Drugs interfering CYP3A4 metabolism (to avoid interaction with Ticagrelor): Ketoconazole, itraconazole, voriconazole, clarithromycin, nefazodone, ritonavir, saquinavir, nelfinavir, indinavir, atazanavir, and telithromizycin.
- Pregnant females*. *Women of childbearing age must use reliable birth control (i.e. oral contraceptives) while participating in the study.
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
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
有源比较器：Prasugrel
Prasugrel 60mg loading dose and 10 mg maintenance dose
|
Prasugrel 60mg loading dose and 10mg maintenance dose
其他名称：
|
|
有源比较器：Ticagrelor
Ticagrelor 180mg loading dose and 90mg bid maintenance dose
|
Ticagrelor 180mg loading dose and 90mg bid maintenance dose
其他名称：
|
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 by Vasodilator-stimulated Phosphoprotein (VASP)
大体时间：1 week
|
The primary end-point of the study was the comparison in the platelet reactivity index (PRI%) determined by vasodilator-stimulated phosphoprotein (VASP) at 1 week between prasugrel and ticagrelor.
|
1 week
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Platelet Reactivity Measured by Vasodilator-stimulated Phosphoprotein (VASP)
大体时间：2 hours
|
A secondary outcome was the comparison between groups of platelet reactivity index (PRI) measured by vasodilator-stimulated phosphoprotein (VASP) at 2 hours after loading dose.
|
2 hours
|
|
Platelet Reactivity Measured by Vasodilator-stimulated Phosphoprotein (VASP)
大体时间：24 hours
|
A secondary outcome was the comparison between groups of platelet reactivity index (PRI) measured by vasodilator-stimulated phosphoprotein (VASP) at 24 hours after loading dose.
|
24 hours
|
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。
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Galli M, Rollini F, Been L, Zenni MM, Angiolillo DJ, Franchi F. Impact of diabetes mellitus on the pharmacodynamic effects of prasugrel and ticagrelor after switching from clopidogrel in patients with coronary artery disease. J Thromb Thrombolysis. 2022 Oct;54(3):461-469. doi: 10.1007/s11239-022-02696-4. Epub 2022 Sep 1.
- Rollini F, Franchi F, Cho JR, DeGroat C, Bhatti M, Muniz-Lozano A, Singh K, Ferrante E, Wilson RE, Dunn EC, Zenni MM, Guzman LA, Bass TA, Angiolillo DJ. A head-to-head pharmacodynamic comparison of prasugrel vs. ticagrelor after switching from clopidogrel in patients with coronary artery disease: results of a prospective randomized study. Eur Heart J. 2016 Sep 14;37(35):2722-30. doi: 10.1093/eurheartj/ehv744. Epub 2016 Feb 3.
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
2012年1月1日
初级完成 (实际的)
2014年6月1日
研究完成 (实际的)
2014年7月1日
研究注册日期
首次提交
2013年5月8日
首先提交符合 QC 标准的
2013年5月10日
首次发布 (估计)
2013年5月13日
研究记录更新
最后更新发布 (估计)
2015年6月10日
上次提交的符合 QC 标准的更新
2015年5月26日
最后验证
2014年8月1日
更多信息
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.