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Early statin treatment against progressing stroke. A Randomised pilot study

Early statin treatment against progressing stroke. A Randomised pilot study - Early statin treatment against progressing stroke. A Randomised pilot study

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000006296
Enrollment
80
Registered
2011-09-20
Start date
2008-03-01
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

acute ischemic stroke

Interventions

Early statin group: atorvastatin 10mg/day immediately after the entry (&lt
48hrs after onset). Statin treatment may be initiated via nasal tube in patients with swallowing difficulty. Delyed statin group: atorvastatin 10mg/day 14days after the entry

Sponsors

Department of Neurology, St. Marianna University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Entry criteria 1. ischemic stroke defined by MRI-DWI. 2. <48 hours after onset 3. Patients have dyslipidemia.

Exclusion criteria

Exclusion criteria: Exclusion criteria 1. statin treatment within 3 months 2. chronic devastating illness 3. stroke caused by arterial dissection, or moyamoya disease 4. acute ischemic heart disease, severe inflammatory disease, autoimmune disease, collagen disease or malignancy requiring treatment 5. pregnancy or possibility of pregnancy 6. recurrent cerebral infarction that had developed 6 months after the previous episode 7. disability with modified Rankin scale (mRS) score ≥2 before onset 8.steroid or NSAID treatment

Design outcomes

Primary

MeasureTime frame
1. Progression in stroke deficits within 14 days(NIHSS>4) 2. Changes in proinfalmmatory biomarkers; hsCRP, IL-6, IL-10, IL-18, MMP-2, MMP-9, TNF-alpha at Day-1,Day-3, Day-7, Day14.

Secondary

MeasureTime frame
1. infarct volume 2. mRS<2 at 90 days

Countries

Japan

Contacts

Public ContactYasuhiro Hasegawa

St. Marianna University School of Medicine Department of Neurology

hasegawa-neuro1@marianna-u.ac.jp044-977-8111

Outcome results

None listed

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