Study to reduce the risk of growth or rupture of a localized dilatation of a blood vessel inside the head by managing risk factors

Phase 1

Conditions: Saccular cerebral aneurysm
MedDRA version: 20.1Level: PTClassification code 10022758Term: Intracranial aneurysmSystem Organ Class: 10029205 - Nervous system disorders
Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Registration Number: EUCTR2017-000514-35-NL

Lead Sponsor: Ruprecht-Karls-University Heidelberg, Medical Faculty Mannheim

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 776

Inclusion Criteria

• 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

Exclusion Criteria

• 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