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Exploratory clinical study of qualitative and quantitative effect with pitavastatin on carotid artery plaque.

Exploratory clinical study of qualitative and quantitative effect with pitavastatin on carotid artery plaque. - TART study

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000008303
Enrollment
50
Registered
2012-06-30
Start date
2012-06-01
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

Hypercholesterolemia with carotid artery plaque

Interventions

Pitavastatin will be administered for 6 months at a dosage of 1~4 mg/day.

Sponsors

Ehime University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1)The patient who observed the plaque in the carotid artery by MRI(Not less than 50% of the degree of stenosis). 2)The patient who is going not to perform CAS and CEA etc. but to perform Follow up. 3)At the time of entry, pitavastatin is not taken. 4)Patients with hypercholesterolemia. 5)Patients aged 20 years or older at the time of giving consent. 6)Patients giving written consent after being provided with sufficient explanation about participation in this clinical trial.

Exclusion criteria

Exclusion criteria: 1)At the time of entry, pitavastatin is taken. 2)The patient who had enforced CAS in the past to the carotid artery plaque lesion which evaluates. 3)Patients who have hypersensitivity to LIVALO tablet. 4)Patients who are being treated with cyclosporine. 5)Patients who have liver dysfunction The following patients considered that biliary obstruction or liver metabolism ability is falling(acute hepatitis, Acute aggravation of chronic hepatitis, hepatic cirrhosis, hepatoma, jaundice) 6)Pregnant women, women suspected of being pregnant, or lactating women 7)Patients who have renal dysfunction, or undergoing dialysis. 8)Patients who are ineligible in the opinion of the investigator.

Design outcomes

Primary

MeasureTime frame
Qualitative and quantitative change of carotid artery plaque by carotid artery echo and MRI evaluation.

Secondary

MeasureTime frame
1)Change of serum lipids(TC,LDL-C,TG,HDL-C). 2)Incidence rate of event. 3)Change of hs-CRP and osteopontin. 4)Evaluation of carotid artery plaque by microbubble contrast material. 5)Evaluation of carotid artery plaque by contrast-enhanced CT. 6) Relationship of change of carotid artery plaque and serum lipids, blood marker. 7)Change of intracranial stenosis.

Countries

Japan

Contacts

Public ContactYoshiaki Kumon

Ehime University Neurosurgery

ykumon@m.ehime-u.ac.jp089-964-5338

Outcome results

None listed

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