Japan Statin Treatment Against Recurrent Stroke (J-STARS)

NCT00221104 | Completed Phase 3 Results

• 2 other identifiers: J-STARSC000000207
• Study Type: interventional
• Target: 1,578
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• Incidence Rate of Stroke and TIA

  Incidence rate of patients with recurrent stroke of any type or transient ischemic attack (TIA)

  up to 5 years

Secondary Outcomes (4)

• Incidence Rate of Atherothrombotic Infarction

  up to 5 years

• Incidence Rate of Lacunar Infarction

  up to 5 years

• Incidence Rate of Cardioembolic Infarction

  up to 5 years

• Incidence Rate of Intracranial Hemorrhage

  up to 5 years

Study Arms (2)

Pravastatin

ACTIVE COMPARATOR

Patient has 10mg oral administration of Pravastatin per day. It starts within one month from their entry and continues every day until the end of the study or its endpoints.

Drug: Pravastatin

No intervention

NO INTERVENTION

Patient has no intervention.

Interventions

Pravastatin DRUG

Pravastatin

Eligibility Criteria

• Age: 45 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan: lead
• Ministry of Health, Labour and Welfare, Japan: collaborator
• Hiroshima University: collaborator

Study Sites (1)

Hiroshima University

Hiroshima, 734-8551, Japan

Location

Related Publications (3)

• 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.

  PMID: 29511130 DERIVED

• 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.

  PMID: 28924103 DERIVED

• 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.

  PMID: 28135841 DERIVED

Related Links

• Japan Statin Treatment Against Recurrent Stroke (J-STARS) only in Japanese

MeSH Terms

Conditions

Ischemic Stroke; Stroke; Brain Ischemia; Hypercholesterolemia; Hyperlipidemias; Recurrence

Interventions

Pravastatin

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Results Point of Contact

• Title: Director of Medical Statistics Division
• Organization: Translational Research Informatics Center, Kobe, Hyogo

kagimura@tri-kobe.org

+81-78-303-9108

Study Officials

• Masayasu Matsumoto, MD, PhD

  Hiroshima University Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 22, 2005
• Study Start: March 1, 2004
• Primary Completion: July 1, 2014
• Last Updated: January 25, 2018
• Results First Posted: January 25, 2018

Record last verified: 2017-06

Locations

JP (1)