Optical Coherence Tomography to Evaluate Ticagrelor and Clopidogrel
2018年3月20日 更新者:Shaoliang Chen、Nanjing First Hospital, Nanjing Medical University
A Randomised, Open-label, Parallel Group, Multi-center Study Using OCT to Comparing the Efficacy and Safety of Ticagrelor With Clopidogrel in the Prevention of Subclinical Thrombus in Patients After Drug-eluting Stent Implantation
A number of 352 patients scheduled for elective percutaneous coronary intervention (PCI) with a native coronary stenosis suitable for DES implantation and OCT imaging are openly randomized 1:1 to either BRILINTA™ (ticagrelor) or Plavix® (clopidogrel bisulfate).
研究概览
详细说明
The study is prospectively conducted at 4 high-volume PCI center in China with OCT expertise.
Angiographic follow-up and OCT imaging with motorized pull-back at 20-36 mm/s are planned in all patients 12 months after implantation of the study stents.
OCT endpoints are: (1) Subclinical intra-stent thrombus, defined as a mass protruding to the lumen with significant attenuation, and respectively (2) endothelial coverage, expressed as % of struts without coverage and % of stent length containing non-covered struts.
The study is powered for OCT endpoints, which are likely to reach significance at the level P < 0.05 even at a follow-up drop-out rate up to 10%.
研究类型
介入性
注册 (实际的)
352
阶段
- 第四阶段
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
-
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Jiangsu
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Nanjing、Jiangsu、中国、210006
- Nanjing First Hospital
-
-
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 及以上 (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:
- Provision of informed consent prior to any study specific procedures;
- Men and women 18 years and older;.
- Established indication to PCI according to the guidelines of American Heart Association and American College of Cardiology;
- Native coronary lesion suitable for drug-eluting stent placement and OCT imaging.
Exclusion Criteria:
- Pregnancy and breast feeding mother;
- Co-morbidity with an estimated life expectancy of < 50 % at 12 months;
- Scheduled major surgery in the next 6 months;
- Inability to follow the protocol and comply with follow-up requirements or any other reason that the investigator feels would place the patient at increased risk;
- Previous enrolment in this study or treatment with an investigational drug or device under another study protocol in the past 30 days
- Cardiogenic shock
- Previous subacute or late coronary stent thrombosis
- Known allergy against ticagrelor, or against clopidogrel, or aspirin
- History of major hemorrhage (intracranial, gastrointestinal, etc.)
- Active pathological bleeding
- Acute or chronic hematologic disorder including a Hemoglobin less than 10 g/L or a platelet count less than 10×109/L before procedure
- Any history of Severe renal or hepatic dysfunction (hepatic failure, cirrhosis, portal hypertension and active hepatitis);
- Neutropenia,
- thrombocytopenia;
- Known acute pancreatitis
- Arterial aneurysm, arterial/venous malformation and aorta dissection.
- Culprit lesion within the proximal 10 mm of the right or left coronary artery
- Saphenous vein grafts
- Lesion length > 30 mm
- Involves a side branch ≥2.0 mm in diameter by visual estimate which requires treatment
- In-stent restenotic lesions
- Thombus-containing lesions
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 |
|---|---|
|
实验性的:Ticagrelor
Ticagrelor 90mg tablet, twice daily
|
Orange brown capsule, containing one 75 mg clopidogrel tablet (cut into 2 halves)
其他名称:
|
|
实验性的:Clopidogrel
Clopidogrel 75mg tablet, daily
|
Plain, round, yellow, filmcoated tablet, 90 mg
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 |
|---|---|---|
|
Subclinical thrombus
大体时间:12 months
|
The occurrence of subclinical thrombus as detected by OCT
|
12 months
|
次要结果测量
结果测量 |
大体时间 |
|---|---|
|
Endothelial coverage of the stent struts assessed by optical coherence tomography
大体时间:12 months
|
12 months
|
|
Neointimal proliferation within the stent assessed by optical coherence tomography
大体时间:12 months
|
12 months
|
|
Stent malposition assessed by optical coherence tomography
大体时间:12 months
|
12 months
|
|
Edge dissections assessed by optical coherence tomography
大体时间:12 months
|
12 months
|
其他结果措施
结果测量 |
大体时间 |
|---|---|
|
Bleeding events
大体时间:12 months
|
12 months
|
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。
调查人员
- 首席研究员:Shaoliang Chen, MD、The First Affiliated Hospital with Nanjing Medical University
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
- Nong JC, You W, Xu T, Meng PN, Xu Y, Wu XQ, Wu ZM, Tao BL, Guo YJ, Yang S, Yin DL, Ye F. Dynamic natural morphologies and component changes in nonculprit subclinical atherosclerosis in patients with acute coronary syndrome at 1-year follow-up and clinical significance at 3-year follow-up. Atherosclerosis. 2022 Sep;356:1-8. doi: 10.1016/j.atherosclerosis.2022.07.013. Epub 2022 Jul 31.
- Wu X, You W, Wu Z, Wu Q, Jiang J, Yan H, Ye F, Chen S. Ticagrelor versus clopidogrel for prevention of subclinical stent thrombosis detected by optical coherence tomography in patients with drug-eluting stent implantation-a multicenter and randomized study. Platelets. 2021 Apr 3;32(3):404-412. doi: 10.1080/09537104.2020.1754381. Epub 2020 Apr 24.
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
2014年5月1日
初级完成 (实际的)
2017年3月8日
研究完成 (实际的)
2017年3月8日
研究注册日期
首次提交
2014年5月14日
首先提交符合 QC 标准的
2014年5月14日
首次发布 (估计)
2014年5月16日
研究记录更新
最后更新发布 (实际的)
2018年3月21日
上次提交的符合 QC 标准的更新
2018年3月20日
最后验证
2018年3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.