NCT07634120Not yet recruitingPhase 2
Vertebrobasilar Dolichoectasia Treatment With Sirolimus: a Pilot Trial Based On 5.0 T MRI
Trial Snapshot
- Phase
- Phase 2
- Status
- Not yet recruiting
- Sponsor
- Huashan Hospital
- Enrollment
- 12
- Locations
- 1
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age≥18 years, any gender;
- •Patients with VBD confirmed by DSA/CTA/MRA;
- •No history of VBD rupture and no surgical treatment for VBD;
- •Positive plasma SGK1;
- •History of posterior circulation infarction or accompanied by VBD-related symptoms/signs;
- •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;
- •Capable of signing an informed consent form with the accompaniment and understanding of a guardian.
Exclusion Criteria
- •History of malignant tumors;
- •Pregnancy or lactation;
- •Sirolimus allergy;
- •Hydrocephalus requiring urgent surgical intervention or respiratory failure requiring life support treatment;
- •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);
- •History of immunosuppressive therapy;
- •Acute cerebral infarction within the last month or definite high signal on DWI indicating acute or subacute cerebral infarction;
- •Acute stage of intracranial hemorrhage as indicated by CT;
- •History of VBD rupture or surgery;
- •Presence of acute active infection (such as severe bacterial, viral or fungal infection);
- •Uncontrolled diabetes (HbA1c≥7%);
- •History of liver or lung transplantation;
- •Presence of organic heart disease;
- •History of arteriovenous thrombosis;
- •Patients taking only antiplatelet drugs or only statin drugs;
- •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.);
- •Currently participating in other clinical studies;
- •Presence of contraindications for MRI examination;
- •Other situations not suitable for inclusion.
Investigators
Wei Zhu
Principal Investigator
Huashan Hospital
Study Sites (1)
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