Clinical trial NCT00221104: Japan Statin Treatment Against Recurrent Stroke (J-STARS)
Official title: Secondary Prevention With HMG-CoA Reductase Inhibitor Against Stroke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Ischemic Stroke
Keywords: stroke
brain ischemia
cerebrovascular accident
statin
hydroxymethylglutaryl-CoA reductase inhibitors
cholesterol
hypercholesterolemia
hyperlipidemia
multicenter studies
prospective studies
endpoint determination
randomized controlled trials
recurrence
pravastatin
Lead sponsor: Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
Sponsor class: OTHER
Collaborators: name: Ministry of Health, Labour and Welfare, Japan
name: Hiroshima University
First posted: 2005-09-22
Enrollment: 1578
Sex: ALL
Minimum age (years): 45
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Although hyperlipidemia is not always the risk factor of stroke, inhibition of 3-hydroxy-3-methylglutaryl-coenzyme A(HMG-CoA) reductase can decrease the incidence of stroke in the patient with ischemic heart disease. The neuroprotective mechanism beyond cholesterol lowering should be expected to attenuate inflammation and atherosclerosis. The present study hypothesizes if pravastatin prevents recurrent stroke in the ischemic stroke patients with safety.


Eligibility criteria: Inclusion Criteria:

* Ischemic stroke except for cardiogenic embolism, from 1 month to 3 years after onset
* Hyperlipidemia and total cholesterol level of 180-240mg/dl without the prescription of statin within previous 30 days
* Able to visit outpatient department
* Informed consent on the form.

Exclusion Criteria:

* Ischemic stroke of other determined cause according to the TOAST classification
* Ischemic heart disease and necessary to use statin
* Hemorrhagic disorders
* Platelet count \<=100,000/ul within 3 months prior to study start
* Alanine aminotransferase (ALT) or aspartate aminotransferase (AST)\>= 100IU/L within 3 months prior to study start
* Serum creatinine \>=2.0mg/dl within 3 months prior to study start
* A scheduled operation
* The presence of malignant disorder

Primary outcomes:
measure: Incidence Rate of Stroke and TIA
timeFrame: up to 5 years
Secondary outcomes:
measure: Incidence Rate of Atherothrombotic Infarction
timeFrame: up to 5 years
measure: Incidence Rate of Lacunar Infarction
timeFrame: up to 5 years
measure: Incidence Rate of Cardioembolic Infarction
timeFrame: up to 5 years
measure: Incidence Rate of Intracranial Hemorrhage
timeFrame: up to 5 years
Other outcomes:
Locations:
city: Hiroshima
country: Japan
facility: Hiroshima University
Study officials:
affiliation: Hiroshima University Hospital
name: Masayasu Matsumoto, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hosomi N, Kitagawa K, Nagai Y, Nakagawa Y, Aoki S, Nezu T, Kagimura T, Maruyama H, Origasa H, Minematsu K, Uchiyama S, Matsumoto M; J-STARS Collaborators. Desirable Low-Density Lipoprotein Cholesterol Levels for Preventing Stroke Recurrence: A Post Hoc Analysis of the J-STARS Study (Japan Statin Treatment Against Recurrent Stroke). Stroke. 2018 Apr;49(4):865-871. doi: 10.1161/STROKEAHA.117.018870. Epub 2018 Mar 6.
citation: Hosomi N, Nagai Y, Kitagawa K, Nakagawa Y, Aoki S, Nezu T, Kagimura T, Maruyama H, Origasa H, Minematsu K, Uchiyama S, Matsumoto M; J-STARS collaborators. Pravastatin Reduces the Risk of Atherothrombotic Stroke when Administered within Six Months of an Initial Stroke Event. J Atheroscler Thromb. 2018 Mar 1;25(3):262-268. doi: 10.5551/jat.40196. Epub 2017 Sep 16.
citation: Nakamura M, Fukukawa T, Kitagawa K, Nagai Y, Hosomi N, Minematsu K, Uchiyama S, Matsumoto M, Miyamoto Y; for J-STARS collaborators. Ten-year standardization of lipids and high-sensitivity C-reactive protein in a randomized controlled trial to assess the effects of statins on secondary stroke prevention: Japan Statin Treatment Against Recurrent Stroke. Ann Clin Biochem. 2018 Jan;55(1):128-135. doi: 10.1177/0004563217693651. Epub 2017 Jul 10.