跳至主要内容
临床试验/EUCTR2014-000952-26-GB
EUCTR2014-000952-26-GB进行中(未招募)1 期

Dual Antiplatelet Therapy to Inhibit Coronary Atherosclerosis and Myocardial Injury in Patients with Necrotic High-risk Coronary Plaque Disease - DIAMOND - Dual Antiplatelet Therapy to Reduce Myocardial Injury

niversity of Edinburgh0 个研究点目标入组 202 人开始时间: 2014年7月4日最近更新:
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试验速览

阶段
1 期
状态
进行中(未招募)
发起方
入组人数
202

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional clinical trial of medicinal product

入排标准

入选标准

  • 1) 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).
  • 2) Provision of informed consent prior to any study specific procedures
  • 3) Receiving aspirin
  • Are the trial subjects under 18? no
  • Number of subjects for this age range: 0
  • F.1.2 Adults (18-64 years) yes
  • F.1.2.1 Number of subjects for this age range 100
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range 150

排除标准

  • 1.An acute coronary syndrome within the last 12 months
  • 2.An indication for dual anti-platelet therapy, such as drug eluting stent
  • 3.Receiving thienopyridine therapy such as clopidogrel or prasugrel
  • 4.Percutaneous coronary intervention or coronary artery bypass graft surgery within the last 3 months
  • 5.Inability or unwilling to give informed consent
  • 6.Women who are pregnant, breastfeeding or of child-bearing potential (women who have experienced menarche, are pre-menopausal and have not been sterilised) will not be enrolled into the trial
  • 7.Known hypersensitivity to ticagrelor or one of its excipients
  • 8.Active pathological bleeding or bleeding diathesis
  • 9.Significant thrombocytopenia: platelets <100 x 109 /L
  • 10. History of intracranial haemorrhage
  • 11.Moderate to severe liver impairment (Child’s Grade B or C)
  • 12.Maintenance therapy with strong CYP3A4 inhibitors, such as ketoconazole, nefazodone, ritonavir, indinavir, atazanavir, or clarithromycin
  • 13.Major intercurrent illness or life expectancy <1 year
  • 14.Renal dysfunction (eGFR =30 mL/min/1.73 m2)
  • 15.Contraindication to iodinated contrast agents
  • 16.Planned coronary revascularization or major non-cardiac surgery in the next 12 months
  • 17. Maintenance therapy with simvastatin or lovastatin at doses greater than 40mg daily
  • 18.Receiving oral anticoagulants including warfarin, rivaroxaban, dabigatran or apixaban.

研究者

发起方
niversity of Edinburgh

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