Exploratory clinical study of pravastatin therapy as a medical treatment for unruptured vertebral artery dissection

Effect of pravastatin therapy on unruptured vertebral artery dissection: a randomized controlled exploratory study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0003597

Enrollment

Registered

2019-03-07

Start date

2018-10-11

Completion date

Unknown

Last updated

2024-03-04

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

Conditions

None listed

Interventions

Drug : Experimental group : Pravastatin[Mevalotin] 40 mg + aspirin[Astrix] 100 mg, oral administration once a day, for 6 months Control group : Aspirin[Astrix] 100 mg, oral administration once a day

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: ? Patients of korean nationality over 20 years old and under 75 years old ? In the last 4 weeks, mildly and medically controlled symptoms occured, excluding hemorrhage and cerebral infarction of a moderate degree or severe, and unruptured vertebral artery dissection related to symptoms is radiologically identified ? Vertebral artery dissection in V3 or V4 segments ? Patients who agreed with this study

Exclusion criteria

Exclusion criteria: ? Vertebral artery dissection with hemorrhagic or moderate to severe ischemic cerebral infarction ? Patients with diabetes or other vascular endothelial abnormalities ? Patients who are currently taking statin or lipid lowering drugs for dyslipidemia or cardiovascular disease ? Patients who had previous endovascular treatment or surgery or radiotherapy in or near the lesion ? Patients with significant underlying disease or active infection or severe trauma ? Patients with poor medication compliance ? Patients with past history of pravastatin, aspirin-induced hypersensitivity and adverse events ? Patients with galactose intolerance, lactose intolerance, Glucose-galactose malabsorption and genetic problem with paravastatin ? severe liver failure(liver cirrhosis) or renal failure(eGFR < 30 ml/min/1.7 m2) ? Patients with past history of myopathy including rhabdomyolysis ? Women who are pregnant or possibly pregnant or who are lactating ? Heavy drinker ? Patients with hemophilia or with bleeding tendency or treated with peptic ulcer ? Patients taking medication which is contraindication of comedication drugs with pravastatin, aspirin or has drug-drug interaction with pravastatin, aspirin

Design outcomes

Primary

Measure	Time frame
Comparative evaluation of the radiologic changes of unruptured vertebral artery dissection on magnetic resonance imaging(MRI) for 6 months compared with MRI performed at the first visit.	—

Secondary

Measure	Time frame
Clinical symptoms;Evaluation of Low-density lipoprotein(LDL) in blood;Evaluation of C-reactive protein(CRP) in blood	—

Countries

Korea, Republic of

Contacts

Public ContactWon Cho

Seoul National University Hospital

nsdrcho@gmail.com+82-2-2072-2824

Outcome results