EUCTR2013-002736-24-SE进行中（未招募）1 期
Does Ticagrelor inhibit growth of small abdominal aortic aneurysms? A randomised controlled trial (TicAAA)
ppsala University0 个研究点目标入组 140 人开始时间: 2013年10月14日最近更新:
适应症
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
- 140
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.Provision of written informed consent
- •2.Male and female subjects
- •3.Age 50-85 years
- •4.Documented infrarenal aortic aneurysm between 35-49 mm
- •5. ASA-naïve (defined as not on regular ASA-treatment within the last 3 months prior to visit 1)
- •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 70
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 70
排除标准
- •Patients should not enter the study if any of the following exclusion criteria are fulfilled:
- •1.Short expected survival.
- •2.On anti-platelet therapy.
- •3.On long-term oral or parenteral anticoagulant treatment.
- •4.On strong inhibitors of CYP3A enzyme (Ketoconazole, Itraconazole, Vorikonazole, Telithromycin, Clarithomycin, Ritonavir, Saquinavir, Nelfinavir, Indinavir, Atazanavir).
- •5.On CYP3A substrates or inducers >40mg daily doses (Simvastatin, Lovastatin, Rifampin/rifampicin, Phenytoin, Carbamazepine, Phenobarbital).
- •6.Known or suspected connective tissue disorder (Marfans syndrome, etc), infected or inflammatory aneurysm, aneurysm post aortic dissection or previous surgery of the infrarenal aorta.
- •7.Increased risk for bradycardia or ongoing treatment with any bradycardia inducing drug.
- •8.Contraindication for Ticagrelor; hypersensitivity to Ticagrelor or any of the excipients, active pathological bleeding, history of intracranial hemorrhage, moderate or severe hepatic impairment (eg, ascites and/or clinical signs of coagulopathy), on haemodialysis.
- •9.Known haemostatic or coagulation disorder, gastrointestinal bleeding within the past 6 months, or increased bleeding risk due to surgery or trauma within 30 days.
- •10.MRI exclusion criteria, such as: severe claustrophobia, pacemaker, metallic implants in brain, cochlear implants.
- •11.Metallic implants in aortic region.
- •12.Enrolled in either another investigational drug or medical device study or another investigational study of an approved drug or medical device within 30 days prior to visit 1 of the current study.
- •13.Any condition or laboratory finding which in the opinion of the Investigator makes the patient unsuitable for inclusion (eg, active malignancy other than squamous cell or basal cell skin cancer, long-term concomitant treatment with non-steroidal anti-inflammatory drugs (NSAIDs).
研究者
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