NL-OMON52612招募中3 期
Prospective Randomised Open-label Trial to Evaluate risk faCTor management in patients with Unruptured intracranial aneurysms (PROTECT-U) - PROTECT
Ruprecht-Karls-University Heidelberg, Medical Faculty Mannheim0 个研究点目标入组 355 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 355
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
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
- •Daily ASA already prescribed for another indication
- •Use of a vitamin K antagonist or direct oral anticoagulant (DOAC) at baseline
- •History of hypersensitivity 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 ASA or other anti-inflammatory drugs
- •Other contra-indications for ASA not yet mentioned, in the dosage of 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 < 30 mL/min/1.73 m2)
- •Pregnancy and lactation
- •Participation in any other clinical trial
- •Life-expectancy <3 years
研究者
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