NCT02070653已完成2 期
Does Ticagrelor Inhibit Growth of Small Abdominal Aortic Aneurysms? A Randomised Controlled Trial (TicAAA)
Uppsala University1 个研究点 分布在 1 个国家目标入组 145 人开始时间: 2014年3月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 145
- 试验地点
- 1
- 主要终点
- AAA volume growth
研究概览
简要总结
Abdominal aortic aneurysm (AAA) is a major health problem and ruptured AAA is a common cause of death in Europe and North America. A key limitation of contemporary treatment strategies of AAA is the lack of therapy directed at reducing expansion. Although surgical repair is an effective treatment for large AAA, it is associated with significant mortality and morbidity as well as substantial cost. The rationale for this randomized controlled study is to investigate whether treatment with Ticagrelor inhibits growth of small abdominal aortic aneurysms.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Provision of written informed consent
- •Male and female patients
- •Age 50-85 years
- •Documented infrarenal aortic aneurysm between 35-49 mm
- •Acetylsalicylic acid (ASA)-naïve
排除标准
- •Short expected survival.
- •On anti-platelet therapy.
- •On long-term oral or parenteral anticoagulant treatment.
- •On strong inhibitors of CYP3A enzyme (Ketoconazole, Itraconazole, Voriconazole, Telithromycin, Clarithromycin, Ritonavir, Saquinavir, Nelfinavir, Indinavir, Atazanavir).
- •On CYP3A (Cytochrome P450, family 3, subfamily A) substrates or inducers >40mg daily doses (Simvastatin, Lovastatin, Rifampin/rifampicin, Phenytoin, Carbamazepine, Phenobarbital).
- •Known or suspected connective tissue disorder (Marfans syndrome, etc), infected or inflammatory aneurysm, aneurysm post aortic dissection or previous surgery of the infrarenal aorta.
- •Increased risk for bradycardia or ongoing treatment with any bradycardia inducing drug.
- •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.
- •Known haemostatic or coagulation disorder, gastrointestinal bleeding within the past 6 months, or increased bleeding risk due to surgery or trauma within 30 days.
- •MRI exclusion criteria, such as: severe claustrophobia, pacemaker, metallic implants in brain, cochlear implants.
- •Metallic implants in aortic region.
- •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.
- •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).
研究组 & 干预措施
Ticagrelor
Active Comparator
Ticagrelor 90 mg tablets twice daily for 12 months.
干预措施: Ticagrelor (Drug)
Placebo
Placebo Comparator
Ticagrelor-placebo tablets twice daily for 12 months.
干预措施: Placebo (Drug)
结局指标
主要结局
AAA volume growth
时间窗: 12 months
To determine mean reduction in AAA volume growth rate (%) measured with magnetic resonance imaging (MRI) at 12 months
次要结局
- AAA diameter growth, need for surgery and rupture(12 months)
研究者
研究点 (1)
Loading locations...
相似试验
进行中（未招募）
1 期
Does Ticagrelor inhibit growth of small abdominal aortic aneurysms? A randomised controlled trial (TicAAA)Small abdominal aortic aneurysmMedDRA version: 14.1Level: LLTClassification code 10000051Term: Abdominal aneurysmSystem Organ Class: 100000004866EUCTR2013-002736-24-SEppsala University140
Unknown
不适用
Captopril Versus Atenolol to Prevent Expansion Rate of Thoracic Aortic AneurysmsAneurysmNCT04224675Onassis Cardiac Surgery Centre424
Unknown
不适用
The Effect of Angiotensin II Type 1 Receptor Antagonists on the Size and Expansion Rate of Abdominal Aortas in Hypertensive PatientsHypertensionAneurysmNCT01670903Sheba Medical Center150
已完成
2 期
A Study to Assess the Effect of Ticagrelor in Reducing the Number of Days With Pain in Patients With Sickle Cell DiseaseSickle Cell DiseaseNCT02482298AstraZeneca87
终止
4 期
Anti-anginal Efficacy of Ticagrelor in Coronary Slow Flow.Coronary Slow Flow PhenomenonCardiovascular - Diseases of the vasculature and circulation including the lymphatic systemACTRN12616000388415niversity of Adelaide24