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DIAMOND - Dual Antiplatelet Therapy to Reduce Myocardial Injury (DIAMOND)

2019年5月9日 更新者:University of Edinburgh

Dual Antiplatelet Therapy to Inhibit Coronary Atherosclerosis and Myocardial Injury in Patients With Necrotic High-Risk Coronary Plaque Disease

Heart attacks are most commonly caused by rupture of fatty deposits (plaques) within the wall of heart blood vessels. It appears that this process can also frequently occur without causing any symptoms and these events likely explain the development of narrowing within the heart arteries which can subsequently produce symptoms of angina (chest pain).

Previous research has shown a specialised scanner known as a PET (positron emission tomography) scan can identify these recently ruptured plaques in patients without symptoms of a heart attack and these patients have changes on a blood test (troponin) which suggest that they are at higher risk of having a heart attack in the future. This study aims to identify these patients using the PET scan and then see if the markers of increased heart attack risk can be reduced by the use of a blood thinning medication (ticagrelor) which is already a well recognised treatment for people who have suffered a recent heart attack.

研究概览

地位

完全的

详细说明

The investigators aim to recruit patients with multivessel, clinically stable coronary artery disease. Patients will undergo baseline investigations including CT-PET imaging using 18F-Sodium Fluoride (18F-F) tracer to detect potentially unstable coronary plaques. The groups will be separated into those with and without 18F-F uptake. Each of these groups will be randomised to receive oral ticagrelor or a matched placebo in addition to their usual medications. Patients will remain on aspirin but will not be eligible for the trial if taking additional antiplatelet/anticoagulant treatments. The treatment will be continued for 1 year.

研究类型

介入性

注册 (实际的)

220

阶段

  • 阶段2
  • 第三阶段

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

    • Lothian
      • Edinburgh、Lothian、英国、EH16 4SA
        • Edinburgh Heart Centre

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

40年 及以上 (成人、年长者)

接受健康志愿者

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Patients aged ≥40 years with angiographically proven multivessel coronary artery disease defined as at least two major epicardial vessels with any combination of either (a) >50% luminal stenosis, or (b) previous revascularization (percutaneous coronary intervention or coronary artery bypass graft surgery).
  • Provision of informed consent prior to any study specific procedures

Exclusion Criteria:

  • An acute coronary syndrome within the last 12 months
  • An indication for dual anti-platelet therapy, such as drug eluting stent
  • Inability to take aspirin
  • Receiving thienopyridine therapy such as clopidogrel or prasugrel
  • Percutaneous coronary intervention or coronary artery bypass graft surgery within the last 3 months
  • Inability or unwilling to give informed consent
  • Woman with child-bearing potential and who are breastfeeding will not be enrolled into the trial (woman who have experienced menarche, are pre-menopausal, have not been sterilised or who are currently pregnant)
  • Known hypersensitivity to ticagrelor or one of its excipients
  • Active pathological bleeding or bleeding diathesis
  • Significant thrombocytopenia: <100 x 10^9 /L
  • History of intracranial haemorrhage
  • Moderate to severe liver impairment (Child's Grade B or C)
  • Maintenance therapy with strong cytochrome P450 3A4 (CYP3A4) inhibitors, such as ketoconazole, nefazodone, ritonavir, indinavir, atazanavir, or clarithromycin
  • Major intercurrent illness or life expectancy <1 year
  • Renal dysfunction (eGFR ≤30 mL/min/1.73 m2)
  • Contraindication to iodinated contrast agents
  • Planned coronary revascularization or major non-cardiac surgery in the next 12 months
  • Maintenance therapy with simvastatin at doses greater than 40mg daily
  • Receiving oral anticoagulants including warfarin, rivaroxaban, dabigatran or apixaban.

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:四人间

武器和干预

参与者组/臂
干预/治疗
实验性的:18F-F Positive - Ticagrelor
Ticagrelor oral tablets, one (90mg) tablet, twice daily, 12 month duration
oral, 90mg tablets, twice daily, 12 month duration
其他名称:
  • 布里林塔
  • 布里利克
  • 波斯尼亚
  • B01AC24
  • AZD6140
  • SUB30898
安慰剂比较:18F-F Positive - Placebo
Identical placebo, one tablet, twice daily, 12 month duration
Oral tablet (identical to ticagrelor), twice daily, 12 month duration
实验性的:18F-F Negative - Ticagrelor
Ticagrelor oral tablets, one (90mg) tablet, twice daily, 12 month duration
oral, 90mg tablets, twice daily, 12 month duration
其他名称:
  • 布里林塔
  • 布里利克
  • 波斯尼亚
  • B01AC24
  • AZD6140
  • SUB30898
安慰剂比较:18F-F Negative - Placebo
Identical placebo, one tablet, twice daily, 12 month duration
Oral tablet (identical to ticagrelor), twice daily, 12 month duration

研究衡量的是什么?

主要结果指标

结果测量
大体时间
Plasma high sensitivity cardiac troponin I (hsTnI) concentration in patients with coronary 18F-fluoride uptake.
大体时间:30 days
30 days

次要结果测量

结果测量
措施说明
大体时间
Plasma hsTnI concentrations in patients without coronary 18F-fluoride uptake.
大体时间:30 days
30 days
High sensitivity cardiac troponin I (hsTnI) concentration in total study population.
大体时间:30 days
30 days
Plasma high-sensitivity troponin (hsTnI) concentration
大体时间:1 year
In total population and in 18F-F PET positive and negative sub-groups
1 year
Calcium score and plaque volume at the site of baseline coronary 18F-fluoride uptake
大体时间:1 year
1 year

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。

合作者

调查人员

  • 学习椅:David E. Newby, PhD、University of Edinburgh
  • 首席研究员:Philip D. Adamson, MBChB、University of Edinburgh

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

2015年3月1日

初级完成 (实际的)

2017年5月26日

研究完成 (实际的)

2018年4月1日

研究注册日期

首次提交

2014年4月7日

首先提交符合 QC 标准的

2014年4月7日

首次发布 (估计)

2014年4月10日

研究记录更新

最后更新发布 (实际的)

2019年5月10日

上次提交的符合 QC 标准的更新

2019年5月9日

最后验证

2019年5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.

Ticagrelor的临床试验

3
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