Effects of 3-hydroxy-3-methyglutaryl-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.

Effects of 3-hydroxy-3-methyglutaryl-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. - Carotid intima-media thickness in Japan Statin Treatment Against Recurrent Stroke (J-STARS echo sub Study)

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-C000000212

Enrollment

800

Registered

2005-09-13

Start date

2004-03-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ischemic stroke

Interventions

Patients will be randomized into the group receiving pravastatin or that having no statin. Intervention consists of pravastain treatment (10mg/day), that will start within 1 month of entry and contin

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Ischemic stroke except for cardiogenic embolism, from 1 month to 3 years after onset 2) 45-80 years old 3) Patients diagnosed as hyperlipidemia 4) No medication of statin within previous 30 days. 5) The total cholesterol level of 180-240mg/dl under no prescription of statin in the previous 30 days 6) Able to visit outpatient department 7) Informed consent on the form filled out by the patient.

Exclusion criteria

Exclusion criteria: 1) Ischemic stroke of other determined causea according to the TOAST classification 2) Ischemic heart disease necessary to require statin 3) Hemorrhagic disorders 4) Platelet count less than 100,000/ul within 3 months before study starts 5) Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) more than 100IU/L within 3 months prior to start of study 6) Serum creatinine more than 2.0mg/dl within 3 months prior to study. 7) Any scheduled operations. 8) The presence of malignant disorder 9) The patients participated in another clinical trial 10) The patient considered being unsuitable for the participation to the study by the medical doctor's judgment. 11) Patients whom carotid ultrasound cannot examine because of neck tumor or torticollis 12) Patients after carotid endarterectomy or radiation therapy to neck

Design outcomes

Primary

Measure	Time frame
Intima-media complex thickness (IMT) of the common carotid artery (CCA)	—

Secondary

Measure	Time frame
Plaque score, number of plaque, recurrent cerebrovascular events	—

Countries

Japan

Contacts

Public ContactNaohisa Hosomi

Hiroshima University Graduate School of Biomedical and Health Sciences Department of Clinical Neuroscience and Therapeutics

naika3@hiroshima-u.ac.jp082-257-5201

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026