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

Phase 1

• Conditions: nruptured intracranial aneurysm; MedDRA version: 21.1Level: PTClassification code 10022758Term: Intracranial aneurysmSystem Organ Class: 10029205 - Nervous system disorders; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2017-000514-35-FI
• Lead Sponsor: Tampere University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-01-29
• Last Update Posted: 14 June 2021

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 (in-house) aneurysm imaging with either CTA/MRA within the last 3 months
•Ability of subject to understand character and individual consequences of clinical a interventional 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 180
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

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 interventional trial
•Life-expectancy <3 years

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified