Clinical trial NCT00361530: Carotid Intima-media Thickness in Japan Statin Treatment Against Recurrent Stroke(J-STARS Echo)
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 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
plaque
tunica intima
tunica media
ultrasonography
carotid arteries
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
name: National Cerebral and Cardiovascular Center, Japan
First posted: 2006-08-08
Enrollment: 854
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: 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.


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
* 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

Primary outcomes:
measure: Intima-media complex thickness (IMT) of the common carotid artery (CCA)
timeFrame: until the last day of the next February after 5-year follow-up survey
Secondary outcomes:
measure: Plaque score, number of plaque, recurrent cerebrovascular events
timeFrame: until the last day of the next February after 5-year follow-up survey
Other outcomes:
Locations:
city: Suita-shi
country: Japan
facility: National Cardiovascular Center (NCVC)
state: Osaka
city: Hiroshima
country: Japan
facility: Hiroshima University Hospital
Study officials:
affiliation: Hiroshima University Hospital
name: Masayasu Matsumoto, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.