Prospective Randomized Open-label Trial to Evaluate risk faCTor management in patients with Unruptured intracranial aneurysms (PROTECT-U)
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 746
- 试验地点
- 20
- 主要终点
- The primary outcome measure will be aneurysm rupture or growth on serial imaging (MR- or CTangiography). Aneurysm growth is defined as an increase in any aneurysm diameter by ≥ 1mm within 36±6 months from randomizantrally by two independent trial radiologists, who will be blinded to the treatment allocation. Events suspicious for SAH but negative CT-imaging will be reviewed centrally by the adjudication committee.
研究概览
简要总结
The primary aim of this study is to assess the hypothesis that a strategy with low-dose ASA (81-100mg/day) and intensive blood pressure treatment (targeted systolic blood pressure below 120mmHg) with weekly measurements using a home blood pressure measuring device reduces the risk of aneurysm rupture or growth compared with standard care (i.e. no ASA, blood pressure management according to guidelines which usually advise treatment if systolic blood pressure exceeds 140mmHg, and no home device for weekly blood pressure measurements).
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 是
入选标准
- •Patient with at least one intradural, saccular unruptured aneurysm in whom it is decided not to intervene with preventive neurosurgical or endovascular aneurysm repair and who are monitored on a regular basis for aneurysm growth
- •18 years or older
- •Last aneurysm imaging with either CTA/MRA within the last 3 months
- •Ability of subject to understand character and individual consequences of clinical trial
- •Not legally incapacitated
- •Written informed consent (must be available before enrolment in the trial)
- •For women with childbearing potential adequate contraception.
排除标准
- •All non-saccular UIAs or aneurysms related to arteriovenous malformations
- •Participation in another interventional clinical trial
- •Life-expectancy <3 years
- •Daily ASA already prescribed for another indication
- •Use of a vitamin K antagonist or direct oral anticoagulant (DOAC) treatment at baseline
- •History of hypersensitivity/allergy to ASA or to any other drug with similar chemical structure or to any excipient present in the pharmaceutical form of ASA
- •History of asthma induced by salicylates or other anti-inflammatory drugs
- •Other contra-indications for ASA not yet mentioned in the dosage of 81-100 mg/day (e.g. bleeding disorders, gastric ulcers and/or intestinal ulcers, acute liver failure of kidney failure, severe heart failure, treatment with methotrexate in a dosage 15 mg/week or above)
- •Use of another platelet aggregation inhibitor, which in combination with ASA would give an unacceptable risk of side effects/complications
- •Chronic kidney disease stage IV and V (GFR <30mL/min/1.73m2)
- •Pregnancy and lactation
结局指标
主要结局
The primary outcome measure will be aneurysm rupture or growth on serial imaging (MR- or CTangiography). Aneurysm growth is defined as an increase in any aneurysm diameter by ≥ 1mm within 36±6 months from randomizantrally by two independent trial radiologists, who will be blinded to the treatment allocation. Events suspicious for SAH but negative CT-imaging will be reviewed centrally by the adjudication committee.
The primary outcome measure will be aneurysm rupture or growth on serial imaging (MR- or CTangiography). Aneurysm growth is defined as an increase in any aneurysm diameter by ≥ 1mm within 36±6 months from randomizantrally by two independent trial radiologists, who will be blinded to the treatment allocation. Events suspicious for SAH but negative CT-imaging will be reviewed centrally by the adjudication committee.
次要结局
- Major spontaneous bleeding requiring hospitalisation defined as substantially disabling bleeding, intraocular bleeding leading to the loss of vision, or bleeding necessitating the transfusion of at least 2 units of erythrocyte concentrates
- Any growth or rupture of aneurysm during follow-up irrespective of the duration of trial participation
- Difference of aneurysm volume (defined as increase of aneurysm volume in computerized measurements from source images by >10% and >3mm3) or aneurysm shape (e.g. development of daughter sac)
- Development of de novo aneurysm on serial imaging
- If a second aneurysm is present: Growth in diameter or volume and alteration of shape of this second aneurysm.
- Clipping/coiling during the study period
- Any ischemic or haemorrhagic stroke, defined as clinical symptoms of stroke AND a compatible lesion on imaging
- Myocardial infarction defined as increase of Troponin, CKMB and/or presence of new significant Q waves obtained in ECG
- Vascular death (including fatal stroke, fatal myocardial infarction, sudden death)
- Death from all other causes
- Blood pressure; any data on blood pressure management used
- Safety aspects (adverse and serious adverse events, including those mentioned above, see also 8.1.6 and 8.2)
- Quality of life (as determined by completion of the paper-based EQ-5D-5L form by patient)
研究者
Prof. Dr. med. Nima Etminan
Scientific
Heidelberg University