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 776 人开始时间: 2018年4月3日最近更新: 2018年4月30日

适应症

试验速览

暂无简介。

•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
•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 700
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 76

•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
•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

发起方

Ruprecht-Karls-University Heidelberg, Medical Faculty Mannheim