Statin Treatment for UnruptureD Intracranial anEurysms Study
Anahtar kelimeler
Öz
Açıklama
Unruptured intracranial aneurysms (UIAs) are increasingly detected and often remain clinically asymptomatic for a long time before rupture. However, once the UIAs ruptured, the incidence of mortality rate varies from 30% to 60% within 6 months. Thus, the risk of UIAs rupture should be weighed, and need an individual criterion for predicting rupture in clinical decision making.
Histopathological studies indicated that inflammation may play an important role in the formation, growth, and rupture of UIAs. Wall enhancement of a saccular aneurysm on high resolution magnetic resonance (HRMRI) is a proven sign of inflammatory change and might predict an unsteady state of an intracranial saccular aneurysm.
Statins inhibit 3-hydroxy-3-methylglutaryl coenzyme A reductase and are established first-line treatments for hypercholesterolemia. Statins produce a range of pleiotropic effects in addition to inhibition of cholesterol synthesis, especially to reduce inflammation, which may be important in reducing the growth and rupture of UIAs.
In the study, participants known to have UIA that is not planned for treatment and has not yet ruptured, take atorvastatin daily for six months, and have an HRMRI scan before and after to look for the role of atorvastatin in inflammation.
Tarih
| Son Doğrulandı: | 09/30/2019 |
| İlk Gönderilen: | 10/29/2019 |
| Tahmini Kayıt Gönderildi: | 10/30/2019 |
| İlk Gönderilen: | 11/03/2019 |
| Son Güncelleme Gönderildi: | 04/28/2020 |
| Son Güncelleme Gönderildi: | 04/30/2020 |
| Fiili Çalışma Başlangıç Tarihi: | 11/06/2019 |
| Tahmini Birincil Tamamlanma Tarihi: | 01/31/2021 |
| Tahmini Çalışma Tamamlanma Tarihi: | 01/31/2021 |
Durum veya hastalık
Müdahale / tedavi
Drug: Atorvastatin
Drug: Placebo
Evre
Kol Grupları
| Kol | Müdahale / tedavi |
|---|---|
| Experimental: Atorvastatin Atorvastatin tablets, 20mg once a day, for six months. | Drug: Atorvastatin One with the intervention (atorvastatin, 20mg OD), 30 patients for this arm. |
| Placebo Comparator: Placebo Same color and size coated tablet, 20mg once a day, for six months. | Drug: Placebo One with the intervention (Placebo, 20mg OD), 30 patients for this arm. |
Uygunluk kriterleri
| Çalışmaya Uygun Yaşlar | 18 Years İçin 18 Years |
| Çalışmaya Uygun Cinsiyetler | All |
| Sağlıklı Gönüllüleri Kabul Ediyor | Evet |
| Kriterler | Inclusion Criteria: 1. Be aged 18 or over, male or non-pregnant female; 2. patients have a saccular UIA identified on imaging (CT, MRI or DSA), and the aneurysm ≥3mm; 3. patients with wall enhancement of aneurysm by MRI VWI before treatment; 4. patients who is able to understand the objective of the trial, agrees and signs the written informed consent form. Exclusion Criteria: 1. Patient with MRI contraindications: metallic implant, contrast allergy, claustrophobia, etc.; 2. Planned treatment of the aneurysm within 6 months; 3. Patient taking the drugs, which might have an anti-inflammatory effect, such as aspirin, statin, immunosuppressive drug, etc. 4. Dyslipidemia or severely impaired liver or renal functions 5. Retreatment of recurrent aneurysm; 6. Pregnant or lactating women; 7. Patients with malignant diseases, such as liver disease, kidney disease, congestive heart failure, malignant tumors, etc; 8. Poor compliance patients. |
Sonuç
Birincil Sonuç Ölçütleri
1. The change in aneurysm wall inflammation as measured by MRI vessel wall imaging (VWI). [6 months]
İkincil Sonuç Ölçütleri
1. Change of aneurysmal morphology between pre-treatment and the 6 months follow-up periods. [6 months]
2. Changes of CRP in UIA patients between pre-treatment and the 6 months follow-up periods. [6 months]
3. Changes of TNF-α in UIA patients between pre-treatment and the 6 months follow-up periods. [6 months]
4. Changes of IL-1β in UIA patients between pre-treatment and the 6 months follow-up periods. [6 months]
5. Changes of IL-6 in UIA patients between pre-treatment and the 6 months follow-up periods. [6 months]
