High dose atorvastatin in acute ischemic stroke ? Monocenter pilot study - ADIS 1.0

Phase 1

• Conditions: acute ischemic stroke; MedDRA version: 9.1Level: LLTClassification code 10057613Term: Thromboembolic stroke

• Registration Number: EUCTR2008-000433-21-IT
• Lead Sponsor: AZIENDA OSPEDALIERA DI BOLOGNA POLICLINICO S. ORSOLA M. MALPIGHI

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-03-17
• Study Completion: 2011-05-16
• Last Update Posted: 8 August 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

1)Clinical-radiological diagnosis of acute ischemic stroke
2)Onset of symptoms within 12 hours before enrolment
3)NIHSS >= 4
4)Age >= 18 years
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1)Inability or refusal of the patient or relative to provide the informed consent
2)Dysphagia associated with impossibility to insert a naso-gastric tube
3)Thrombolytic treatment of stroke
4)Patient already under statin treatment
5)Known statin intolerance
6)Modified Rankin Scale > 3 before the acute stroke
7)Pregnancy
8)Malignancy
9)Liver cirrhosis
10)Chronic hepatitis
11)Jaundice
12)Alcoholism
13)Acute hepatic failure
14)Concurrent treatment with cyclosporin, erythromycin, clarithromycin, itraconazole, ketoconazole, nefazodone, niacin, gemfibrozil, other derivatives of fibric acid or inhibitors of HIV proteases.
15)Baseline AST or ALT or CPK > 3 fold the maximum normal limit

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Secondary Objective: To define the premises for a larger multicenter study with similar objectives.;Primary end point(s): Primary end-point<br>1) NIHSS decrease >= 4 points (at 7 days)<br><br>Secondary end-points<br>1)Brain infarct volume at CT scan (after 3 days)<br>2)Modified Rankin scale <=2 (at 3 months);Main Objective: To show favorable effects of the early administration of atorvastatin 80 mg/day in acute ischemic stroke, on the short term development of neurological deficit and extension of brain lesion, and on the medium term handicap degree.<br>To define the premises for a larger multicenter study with similar objectives.