Unruptured Intracranial Aneurysm Aspirin Trial (UIAAT).
关键词
抽象
描述
The Unruptured Intracranial Aneurysm Aspirin Trial (UIAAT) is a single centre, randomised, single blind, open label trial of 300mg aspirin daily versus no treatment for 3 months. 58 patients with an intracranial aneurysm diagnosed on imaging will be recruited - potential participants will be approached by their consultant neurosurgeon or a member of their direct clinical care team.
Patient interviews will take place at Wessex Neurological Centre to coincide wherever possible with standard appointments. Participants will be screened for eligibility and consented during this interview. Following consent, baseline data will be taken to include participants' baseline characteristics, other medications, and comorbidities.
The patients will then undergo a baseline MRI including VWI imaging, and then be randomised to either the 'aspirin 300mg daily' or 'no treatment' arms.
All participants will then be called by a member of the trial team between days 7 and 21 after being commenced in either arm of the trial, to review any issues with taking the medication if they are on that arm, whether they are using their drug diary, and to check for any adverse reactions or events.
Following three months of their allocated treatment, patients will undergo a second, identical MRI scan, to assess whether there is any reduction in the inflammation in the vessel walls of the aneurysms. Patients will be reviewed at this time with their drug dairy, for drug reconciliation and recording of any adverse events. This will be the end of their participation in the trial.
The study topic and design was discussed at a meeting to set research priorities advertised via the Wessex Subarachnoid Haemorrhage group that was convened by a consultant neurosurgeon and a subarachnoid haemorrhage specialist nurse with patients with unruptured and ruptured aneurysms and their carers. At this meeting the investigators clearly identified that it would be beneficial for more research into medical treatments for unruptured aneurysms and felt that with the evidence that the group would be happy to undergo the main two items required for participation in the study - treatment with aspirin and increased scanning frequency and were very supportive of the study design. Indeed the group saw the additional scanning as a strong attraction to participating in the study.
日期
最后验证: | 07/31/2019 |
首次提交: | 07/11/2018 |
提交的预估入学人数: | 09/04/2018 |
首次发布: | 09/06/2018 |
上次提交的更新: | 10/23/2019 |
最近更新发布: | 10/27/2019 |
实际学习开始日期: | 10/23/2019 |
预计主要完成日期: | 11/30/2019 |
预计完成日期: | 11/30/2019 |
状况或疾病
干预/治疗
Drug: Aspirin
相
手臂组
臂 | 干预/治疗 |
---|---|
Experimental: Aspirin Aspirin (Acetylsalicylic Acid [ASA]) tablets, 300mg once a day, for 90 days. | Drug: Aspirin Drug |
No Intervention: No Treatment No medical treatment |
资格标准
有资格学习的年龄 | 18 Years 至 18 Years |
有资格学习的性别 | All |
接受健康志愿者 | 是 |
标准 | Inclusion Criteria: Participants who will be eligible for inclusion in the study will: - Have a saccular unruptured intracranial aneurysm identified on imaging (CT, MRI or DSA), - Aneurysm ≥5mm - Be aged 18 or over - Male or female - Capable of giving written informed consent - Females of childbearing potential must have a negative pregnancy test. Patients of childbearing potential must agree to use an effective birth control method to avoid pregnancy for the duration of the study. Exclusion Criteria: Participants will be ineligible for inclusion in the study if they have any of the following:- - aneurysms smaller than 5mm in size. - Aneurysm types of the following nature: - Fusiform aneurysms - Dissecting aneurysm - Traumatic aneurysms - Cavernous aneurysms - Thrombosed aneurysm - MRI contraindications: - Metallic implant - Contrast allergy - Claustrophobia - Aspirin contraindications (or increased risk): - Peptic ulceration - Bleeding disorder - Haemophilia - Previous peptic ulceration - Severe cardiac failure - Severe hepatic dysfunction - Severe renal failure - Allergy to aspirin or NSAIDs - Pregnancy - Breastfeeding - Alcoholism - Steroid usage - Severe asthma - Gout - Current warfarin or other anticoagulant use - Current aspirin or clopidogrel use - Current NSAID use more than once a month - Planned treatment of the aneurysm within 3 months |
结果
主要结果指标
1. A reduction in aneurysm wall inflammation as measured by MRI vessel wall imaging (VWI). [3 months]