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Small Unruptured Aneurysm Vertification-Prevention Effect Against Growth of Cerebral Aneurysm Study Using Statin

Small Unruptured Aneurysm Vertification-Prevention Effect Against Growth of Cerebral Aneurysm Study Using Statin - Small Unruptured Aneurysm Vertification-Prevention Effect Against Growth of Cerebral Aneurysm Study Using Statin

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000005135
Enrollment
1000
Registered
2011-05-02
Start date
2011-04-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

small unruptured cerebral aneurysm

Interventions

atorvastatin group: atorvastatin is administered at a daily dose of 10 mg for 3 years. non-administration group

Sponsors

Department of neurosurgery, faculty of medicine, Kyoto university
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) small unruptured cerebral saccular aneurysms (more than 3 mm and under 5 mm) diagnosed within 3 years from the date of registration. 2) aneurysms located in the circle of Willis or distal to the circle of Willis. 3) aneurysms are to be followed by MRA without surgical intervention after registration. 4) informed consent was obtained from the patient. 5) age of the patient is more than 20 and under 70 at the date of registration. 6) modified Rankin scale: 0~2 7) patients are capable of visiting out-patient clinic

Exclusion criteria

Exclusion criteria: 1) comorbid untreated unruptured aneurysms larger than 5mm 2) within 6 months after direct/endovascular surgery for comorbid aneurysms 3) when comorbid surgically treated aneurysm is a giant aneurysm 4) patients with hyperlipidemia who need medical treatment 5) patients receiving fenofibrate 6) atorvastatin hypersensitivity 7) patients receiving anticoagulant or antithrombotic 8) patients with a history of intracerebral hemorrhage 9) patients with a history of cerebral infarct within 6 months 10) comorbid arteriovenous malformation 11) comorbid moyamoya disease 12) patients with severe hepatic dysfunction 13) alcohol intoxication 14) patient during pregnancy or lactation 15) medically uncontrolled hypertension 16) patient under treatment for malignancy 17) cardiac failure, myocardial infarction or unstable angina within 6 months 18) renal failure 19) respiratory failure 20) patients disqualified by the physician-in-charge

Design outcomes

Primary

MeasureTime frame
1)aneurysm enlargement over 0.5 mm 2)aneurysm morphological change (e.g., bleb formation) 3)rupture

Secondary

MeasureTime frame
cardiovascular events

Countries

Japan

Contacts

Public ContactKazuimichi Yoshida

Kyoto university, faculty of medicine neurosurgery

pegasus@kuhp.kyoto-u.ac.jp075-751-3459

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026