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。

Ticagrelor and Aspirin for the Prevention of Cardiovascular Events After Coronary Artery Bypass Surgery (TAP-CABG)

2015年3月24日 更新者：Dr. Jacqueline Saw、Cardiology Research UBC

Ticagrelor and Aspirin for the Prevention of Cardiovascular Events After Coronary Artery Bypass Surgery (CABG)

Subjects will be consented to the study prior to Coronary Artery Bypass Graft (CABG) and randomly assigned to receive either ticagrelor 90 mg bid or placebo bid starting within 48 hours of surgery. Subjects will remain on study drug for a minimum of 12 months during which time they will receive telephone follow-up one and nine months following CABG and clinic visits three, six, and twelve months following CABG.

研究概览

地位

完全的

条件

干预/治疗

详细说明

Patients will be screened for eligibility pre-CABG, and informed consent signed before randomization. Aspirin 81mg/d will be started within 12 hours of CABG as per routine practice. Study medication will be started within 48 hours after CABG if there are no contraindications. Patients will be randomized to ticagrelor 90mg bid (no loading dose) or placebo bid for 1 year following CABG. Aspirin 81mg/d will be continued for at least 1 year post-CABG. Other cardiac medications will be at the discretion of the treating physicians as per standard practice.

Patients will be followed daily during their hospital stay. Outpatient visits will be scheduled at 3, 6 and 12 months. There will also be telephone contacts at 1 and 9 months.

CT Substudy:Patients in the CT angiography substudy(the first 240 enrolled subjects) will have a cardiac CT angiogram to evaluate bypass graft patency at 3-month follow-up.Grafts will be separately evaluated based upon the conduits used, internal mammary, radial, or saphenous vein grafts. Graft patency is defined as contrast filling of the conduit and the coronary artery beyond the anastomosis. Grafts with ≥50% stenosis will also be recorded. The location of the stenosis will also be recorded (proximal anastomosis, body of graft, or distal anastomosis). CT angiograms will be evaluated by 2 interpreters (radiologists or cardiologists) blinded to the randomized treatment, and will be reviewed by a 3rd interpreter if there are disagreements. If no consensus could be reached among the 3 interpreters, the graft will be deemed not analyzable, or be subject to invasive coronary angiography for definitive assessment if clinically indicated.

The primary efficacy endpoint is the composite of all-cause mortality, MI, stroke, or repeat revascularization within 1 year following CABG. Secondary endpoints include the individual endpoints of all-cause mortality, cardiovascular death, MI, stroke, repeat revascularization.

研究类型

介入性

注册 (实际的)

70

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

  • 加拿大
    • British Columbia
      • Vancouver、British Columbia、加拿大
        • Vancouver General 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

19年 至 80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:

  1. Males or females ≥ 19 years and ≤ 80 years old undergoing isolated CABG
  2. Females of child-bearing age must have a negative pregnancy test at enrollment

Exclusion Criteria:

  1. Patients undergoing combined valve or aortic surgeries
  2. Patients requiring oral anticoagulant therapy on discharge that cannot be stopped (e.g. atrial fibrillation with CHADS2 score ≥ 2, pulmonary embolism, deep venous thrombosis)
  3. Known allergy or intolerance to aspirin, clopidogrel or ticagrelor
  4. Patients with active bleeding or history of bleeding diathesis
  5. Patients with previous intracranial hemorrhage at any time, or ischemic stroke within 14 days
  6. Patients with severe liver disease (e.g. ascites or signs of coagulopathy)
  7. Patients with pre-operative or persistent post-operative Type 2 second-degree AV block, or 3rd degree AV block, without a permanent pacemaker
  8. Patients with end-stage renal failure requiring dialysis
  9. For patients enrolled in the CT angiography substudy, renal dysfunction with eGFR < 50 ml/min is an exclusion criteria

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：预防
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：三倍

武器和干预

参与者组/臂
干预/治疗
安慰剂比较：Placebo
Placebo twice daily. Study drug will be started within 48 hours of CABG.
药品：Placebo
Placebo 1 pill BID for 90 days
有源比较器：ticagrelor 90 mg
Taken twice daily. Study drug will be started within 48 hours of CABG.
药品：ticagrelor
ticagrelor 90 mg BID for 90 days
其他名称：
  • 布里林塔

研究衡量的是什么？

主要结果指标

结果测量
大体时间
Composite of all-cause mortality, MI, stroke, or repeat revascularization
大体时间：within one year following CABG
within one year following CABG

次要结果测量

结果测量
措施说明
大体时间
Improving graft patency
大体时间：3 months post-CABG
The secondary study objective is to evaluate if the combination of ticagrelor and aspirin administered after CABG will improve graft patency at 3 months, compared with aspirin alone. This will be monitored and assessing in the CT angiography substudy.
3 months post-CABG

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。

赞助

Cardiology Research UBC

合作者

University of British Columbia

调查人员

  • 首席研究员：Jackie Saw, BSc, MD, FRCPC、University of British Columbia

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

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

2011年9月1日

初级完成 (实际的)

2015年3月1日

研究完成 (实际的)

2015年3月1日

研究注册日期

首次提交

2011年6月13日

首先提交符合 QC 标准的

2011年6月14日

首次发布 (估计)

2011年6月15日

研究记录更新

最后更新发布 (估计)

2015年3月26日

上次提交的符合 QC 标准的更新

2015年3月24日

最后验证

2013年3月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • H10-01452

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.

Placebo的临床试验

搜索类似试验

赞助者和合作者

医疗条件

药物干预

CROs by country

CROs in Czech Republic

条件

罕见疾病

药物干预

膳食补充剂

赞助者/合作者

地点

3
订阅