EUCTR2014-001989-97-AT进行中（未招募）1 期
Clinical study to investigate the efficiency of vascular occlusion prevention by ticagrelor after stent implantation in patients with peripheral artery disease (PAD) and high platelet reactivity during treatment with clopidogrel
OA Doz. Dr. Thomas Müller c/o B&S Zentrallabor Konventhospital Barmherzige Brüder Linz0 个研究点目标入组 500 人开始时间: 2014年6月13日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 500
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
- 性别
- All
入选标准
- •1.)written consent to participate after previous sufficient written and oral information (informed consent)
- •2.)arteriosclerotic PAD (Fontaine stages II – IV or Rutherford stages 1 – 6)
- •3.)implantation of a bare-metal stent into the Arteria femoralis superficialis of at least one leg one day ago (first intervention at this vessel)
- •4.)Proper intake of Plavix ® since stent implantation (including routine intake of one Plavix ® film-coated tablet à 75mg clopidogrel in the morning immediately before inclusion in the clinical trial)
- •5.)suspected availability within the one-year period of the study participation (out-patient care)
- •6.)suspected discharge from the hospital within a week after stent implantation
- •7.)caucasian appearance
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 200
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 300
排除标准
- •1.)non-completion of the 18th year of life
- •2.)detention (for a court or administrative order), accommodation (in accordance with the Placement Act) or (already performed or initiated) appointment of a custodian
- •3.)incapability
- •4.)military service
- •5.)pregnancy and non-exclusion of pregnancy (women of childbearing potential)
- •6.)risk of pregnancy occurrence during the test participation
- •7.)lactation
- •8.)(with the exception of taking ASS up to 150 mg daily) intake of other TAH than clopidogrel since stent implantation
- •9.)(with the exception of maintaining a long-term therapy with ASS up to 150 mg daily) foreseeable need for intake of further TAH within the one-year period of study participation
- •10.)contraindication for Plavix ® or Brilique ® administration
- •a.hypersensitivity to any component of Plavix ® or Brilique ®
- •b.acute pathological bleeding e.g. at peptic ulcer or intracranial bleeding
- •c.intracranial hemorrhage in history
- •d.moderate to severe hepatic impairment
- •e.use of CYP3A4 inhibitors (e.g. ketoconazole, clarithromycin, nefazodone, ritonavir and atazanavir)
- •11.)bypass surgery and / or stent implantation into the affected vessel in history
- •12.)intake of anticoagulants (vitamin K antagonists or new direct oral anticoagulants such as dabigatran, rivaroxaban or apixaban) in the last week
- •13.)suspected demand of taking anticoagulants (vitamin K antagonists or new direct oral anticoagulants such as dabigatran, rivaroxaban, apixaban or) within the one-year period of study participation
- •14.)myocardial infarction (STEMI or NSTEMI) or acute ischemic stroke in the last 30 days
- •15.)acute or non-arteriosclerotic PAOD (e.g. arterial thrombotic or embolic event, thromboangiitis obliterans, vasculitis, congenital or metabolic vascular disease, etc.)
- •16.)malignant neoplasm (status post or existing)
- •17.)platelets <100 G/L
- •18.)hematocrit <30% or> 52%
- •19.)uremia or glomerular filtration rate <30ml/min/1. 73m ²
- •20.)liver cirrhosis or bilirubin> 2mg/dl or GPT and / or GOT> 1.5 of the upper reference value
- •21.)simultaneous participation in another clinical study with insurance coverage
研究者
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