hsCRP in Japan Statin Treatment Against Recurrent Stroke (J-STARS hsCRP)

NCT00361699 | Completed Phase 3

• 2 other identifiers: J-STARS hsCRPC000000211
• Study Type: interventional
• Target: 1,095
• Locations: 1 country
• Sites: 2

Brief Summary

Inhibition of 3-hydroxy-3-methylglutaryl-coenzyme A(HMG-CoA) reductase can play a role in preventing recurrent vascular events from ischemic heart disease patients, whose mechanism consists in not only the reduction of serum lipid level but also anti-inflammatory effects. Serum high sensitive CRP is known to be a predictor of cardiovascular events independent of other conventional risk factors. The present substudy examine whether such pleiotrophic effect of HMG-CoA reductase inhibitor (statin) which decreases high sensitive CRP would be observed in the post-ischemic stroke patients who have already been registered in the J-STARS, and the relationship the values of high sensitive CRP and recurrence of stroke.

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; c-reactive Protein

Outcome Measures

Primary Outcomes (1)

• serum level of high sensitive CRP

  until the last day of the next February after 5-year follow-up survey

Secondary Outcomes (1)

• recurrent stroke

  until the last day of the next February after 5-year follow-up survey

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: Statin

No intervention

NO INTERVENTION

Patient has no intervention.

Interventions

Statin 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 filled in by the patient.

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
• Osaka University: collaborator

Study Sites (2)

Hiroshima University Hospital

Hiroashima, Hiroshima, 734-8551, Japan

Location

Osaka University

Suita-shi, Osaka, 565-0871, Japan

Location

Related Links

• Available only in Japanese

MeSH Terms

Conditions

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

Interventions

Hydroxymethylglutaryl-CoA Reductase Inhibitors

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)

Anticholesteremic Agents; Hypolipidemic Agents; Antimetabolites; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Enzyme Inhibitors; Lipid Regulating Agents; Therapeutic Uses

Study Officials

• Masayasu Matsumoto, MD, PhD

  Hiroshima University Hospital

  PRINCIPAL INVESTIGATOR

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: August 7, 2006
• First Posted: August 8, 2006
• Study Start: March 1, 2004
• Primary Completion: July 1, 2014
• Last Updated: April 25, 2016

Record last verified: 2016-04

Locations

JP (2)