Carotid Intima-media Thickness in Japan Statin Treatment Against Recurrent Stroke(J-STARS Echo)

• ClinicalTrials.gov Identifier: NCT00361530
• Recruitment Status: Completed
• First Posted: August 8, 2006
• Last Update Posted: April 25, 2016
• Sponsor: Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
• Collaborators: Ministry of Health, Labour and Welfare, Japan; Hiroshima University; National Cerebral and Cardiovascular Center
• Information provided by (Responsible Party): Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan

Study Description

Brief Summary:

Carotid ultrasound can reveal the intima-media complex thickness(IMT), that has been reported to be a marker of atherosclerosis as well as a risk of cardiovascular events, and to be attenuated by 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase inhibitors (statins) . This substudy of J-STARS will observe the temporal profile of carotid IMT prospectively in the patients with prescription of pravastatin and the control.

Condition or disease	Intervention/treatment	Phase
Ischemic Stroke	Drug: Statin	Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 854 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Effect of 3-hydroxy-3-methylglutaryl-coenzyme A(HMG-CoA) Reductase Inhibitor Upon Carotid Intima-media Complex Thickness in the Post-ischemic Patients With Hyperlipidemia During the Prospective Study of J-STARS.
• Study Start Date: March 2004
• Actual Primary Completion Date: July 2014

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Pravastatin; 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.

Outcome Measures

Primary Outcome Measures :

1. Intima-media complex thickness (IMT) of the common carotid artery (CCA) [ Time Frame: until the last day of the next February after 5-year follow-up survey ]

Secondary Outcome Measures :

1. Plaque score, number of plaque, recurrent cerebrovascular events [ Time Frame: until the last day of the next February after 5-year follow-up survey ]

Eligibility Criteria

• Ages Eligible for Study: 45 Years to 80 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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
• Patients whom carotid ultrasound cannot examine because of neck tumor or torticollis
• Patients after carotid endarterectomy or radiation therapy to neck
• Patients whose carotid ultrasound cannot be examined because of neck tumor or torticollis
• Patients after carotid endarterectomy or radiation therapy to neck

Contacts and Locations

Locations

Japan

National Cardiovascular Center (NCVC)

Suita-shi, Osaka, Japan, 565-0873

Hiroshima University Hospital

Hiroshima, Japan, 734-8551

Sponsors and Collaborators

Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan

Ministry of Health, Labour and Welfare, Japan

Hiroshima University

National Cerebral and Cardiovascular Center

Investigators

• Principal Investigator: Masayasu Matsumoto, MD, PhD; Hiroshima University Hospital

More Information

Additional Information:

Related Info 

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Wada S, Koga M, Minematsu K, Toyoda K, Suzuki R, Kagimura T, Nagai Y, Aoki S, Nezu T, Hosomi N, Origasa H, Ohtsuki T, Maruyama H, Yasaka M, Kitagawa K, Uchiyama S, Matsumoto M. Baseline Carotid Intima-Media Thickness and Stroke Recurrence During Secondary Prevention With Pravastatin. Stroke. 2019 Jun;50(6):1586-1589. doi: 10.1161/STROKEAHA.119.024968. Epub 2019 Apr 30.

Koga M, Toyoda K, Minematsu K, Yasaka M, Nagai Y, Aoki S, Nezu T, Hosomi N, Kagimura T, Origasa H, Kamiyama K, Suzuki R, Ohtsuki T, Maruyama H, Kitagawa K, Uchiyama S, Matsumoto M; J-STARS Investigators. Long-Term Effect of Pravastatin on Carotid Intima-Media Complex Thickness: The J-STARS Echo Study (Japan Statin Treatment Against Recurrent Stroke). Stroke. 2018 Jan;49(1):107-113. doi: 10.1161/STROKEAHA.117.018387. Epub 2017 Nov 30.

• Responsible Party: Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
• ClinicalTrials.gov Identifier: NCT00361530
• Other Study ID Numbers: J-STARS echo; C000000212 ( Other Identifier: UMIN CTR )
• First Posted: August 8, 2006
• Last Update Posted: April 25, 2016
• Last Verified: April 2016

Keywords provided by Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan:

stroke; brain ischemia; cerebrovascular accident; statin; hydroxymethylglutaryl-CoA Reductase Inhibitors; cholesterol; hypercholesterolemia; hyperlipidemia; multicenter studies; prospective studies; endpoint determination; randomized controlled trials; recurrence; pravastatin; plaque; tunica intima; tunica media; ultrasonography; carotid arteries

Additional relevant MeSH terms:

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases