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NOT YET RECRUITING

NCT07634120

PHASE2

Vertebrobasilar Dolichoectasia Treatment With Sirolimus

Sponsor: Huashan Hospital

View on ClinicalTrials.gov

Summary

The aim of this pilot trial is to assess the efficacy of sirolimus in reducing wall enhancement in vertebrobasilar dolichoectasia(VBD) on 5 T high-resolution magnetic resonance vessel wall imaging(HR-VWI) via anti-inflammatory mechanisms, clarify the efficacy of sirolimus in delaying the progression of VBD, evaluate the safety of sirolimus in the treatment of VBD.

Official title: Vertebrobasilar Dolichoectasia Treatment With Sirolimus: a Pilot Trial Based On 5.0 T MRI

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

Start Date

2026-06

Completion Date

2027-12

Last Updated

2026-06-08

Healthy Volunteers

Conditions

Vertebrobasilar Dolichoectasia

Interventions

DRUG

Sirolimus

Sirolimus is an mTORC1/ mTORC2 inhibitor that has received approval from the U.S. Food and Drug Administration (FDA) and has recently been successfully used to treat lymphatic malformations and venous/lymphatic malformations associated with the same PIK3CA GOF mutations. Participants of sirolimus group will receive oral sirolimus 2mg/d continuously for 6 months.

Inclusion Criteria: 1. Age≥18 years, any gender; 2. Patients with VBD confirmed by DSA/CTA/MRA; 3. No history of VBD rupture and no surgical treatment for VBD; 4. mRS\<4; 5. Positive plasma SGK1; 6. History of posterior circulation infarction or accompanied by VBD-related symptoms/signs; 7. Currently and in the future, need to take antiplatelet and statin drugs simultaneously, or currently and in the future, do not need to take antiplatelet and statin drugs; 8. Capable of signing an informed consent form with the accompaniment and understanding of a guardian. Exclusion Criteria: 1. History of malignant tumors; 2. Pregnancy or lactation; 3. Sirolimus allergy; 4. Hydrocephalus requiring urgent surgical intervention or respiratory failure requiring life support treatment; 5. Abnormal hepatic and/or renal function (serum transaminase \> 40 U/L; serum creatinine \> 110 μmol/L); and/or abnormal white blood cells/platelets (white blood cells count \< 3.5 × 10⁹/L or \> 9.5 × 10⁹/L; platelets count \< 100 × 10⁹/L or \> 300 × 10⁹/L); 6. History of immunosuppressive therapy; 7. Acute cerebral infarction within the last month or definite high signal on DWI indicating acute or subacute cerebral infarction; 8. Acute stage of intracranial hemorrhage as indicated by CT; 9. History of VBD rupture or surgery; 10. Presence of acute active infection (such as severe bacterial, viral or fungal infection); 11. Uncontrolled diabetes (HbA1c≥7%); 12. History of liver or lung transplantation; 13. Presence of organic heart disease; 14. History of arteriovenous thrombosis; 15. Patients taking only antiplatelet drugs or only statin drugs; 16. Patients taking or needing to take CYP3A4 inhibitors (ketoconazole, itraconazole, voriconazole, clarithromycin, erythromycin, telithromycin, ritonavir, atazanavir, diltiazem, verapamil, cyclosporine, amiodarone, sildenafil, grapefruit juice, etc.) or CYP3A4 inducers (rifampicin, rifabutin, phenobarbital, phenytoin, carbamazepine, dexamethasone, St. John's wort, etc.); 17. Currently participating in other clinical studies; 18. Presence of contraindications for MRI examination; 19. Other situations not suitable for inclusion.

Locations (1)

Huashan Hospital, Fudan University

Shanghai, Shanghai Municipality, China