Clinical trial NCT00711919: Pitavastatin on Carotid Intima-media Thickness
Official title: Pitavastatin Evaluation of Atherosclerosis Regression by Intensive Cholesterol-Lowering Therapy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hyperlipidemia
Carotid Artery Diseases
Lead sponsor: Kyoto Prefectural University of Medicine
Sponsor class: OTHER
First posted: 2008-07-09
Enrollment: 300
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is aimed to analyze the effects of aggressive and conventional lipid lowering therapy with Pravastatin on carotid intima-media thickness (IMT) in patients with hyperlipidemia and abnormal thickening of IMT.


Eligibility criteria: Inclusion Criteria:

* Diagnosed as having hyperlipidemia
* LDL-C at the time of enrollment is no less than 100
* Common carotid IMT is 1.1 mm and over

Exclusion Criteria:

* Received or planned to receive intervention on carotid arteries during the study period
* Overt liver dysfunction (ALT; 100 IU/L and over)
* Overt renal dysfunction (serum creatinine; 2.0 mg/dL and over)
* Receiving Cyclosporin
* Hyperreactive to Pitavastatin
* During pregnancy or lactation

Primary outcomes:
measure: absolute changes in carotid intima-media thickness from baseline to final visit
timeFrame: 12 months
Secondary outcomes:
measure: relative change in carotid intima-media thickness
timeFrame: 12 months
measure: change in LDL-C, HDL-C, TG and RLP-C
timeFrame: 12 months
measure: change in hs-CRP and IL-6
timeFrame: 12 months
measure: new onset or recurrence of ischemic heart disease, heart failure, stroke and atherosclerosis obliterans
timeFrame: 12 months
measure: sudden death
timeFrame: 12 months
measure: side effects
timeFrame: 12 months
Other outcomes:
Locations:
city: Ayabe
country: Japan
facility: Ayabe City Hospital
state: Kyoto
city: Fukuchiyama
country: Japan
facility: Fukuchiyama City Hospital
state: Kyoto
city: Kyotanabe
country: Japan
facility: Tanabe Central Hospital
state: Kyoto
city: Kyotango
country: Japan
facility: Kumihama Hospital
state: Kyoto
city: Maizuru
country: Japan
facility: Maizuru Medical Center
state: Kyoto
city: Maizuru
country: Japan
facility: Maizuru Kyosai Hospital
state: Kyoto
city: Nagaokakyo
country: Japan
facility: Saiseikai Kyoto Hospital
state: Kyoto
city: Nantan
country: Japan
facility: Nantan General Hospital
state: Kyoto
city: Nantan
country: Japan
facility: Meiji University of Integrative Medicine Hospital
state: Kyoto
city: Seika
country: Japan
facility: Gakken Toshi Hospital
state: Kyoto
city: Uji
country: Japan
facility: Uji Hospital
state: Kyoto
city: Yosano
country: Japan
facility: Kyoto Prefectural Yosanoumi Hospital
state: Kyoto
city: Higashioumi
country: Japan
facility: Shiga Hospital
state: Shiga
city: Omihachiman
country: Japan
facility: Omihachiman Community Medical Center
state: Shiga
city: Rittou
country: Japan
facility: Saiseikai Shigaken Hospital
state: Shiga
city: Kyoto
country: Japan
facility: Takeda Hospital
city: Kyoto
country: Japan
facility: Kyoto Prefectural University of Medicine
city: Kyoto
country: Japan
facility: Kyoto First Red Cross Hospital
Study officials:
affiliation: Kyoto Prefectural University of Medicine
name: Hiroaki Matsubara, MD, PhD
role: STUDY_CHAIR
References:
citation: Ikeda K, Takahashi T, Yamada H, Matsui K, Sawada T, Nakamura T, Matsubara H; (for the PEACE Investigators). Effect of intensive statin therapy on regression of carotid intima-media thickness in patients with subclinical carotid atherosclerosis (a prospective, randomized trial: PEACE (Pitavastatin Evaluation of Atherosclerosis Regression by Intensive Cholesterol-lowering Therapy) study). Eur J Prev Cardiol. 2013 Dec;20(6):1069-79. doi: 10.1177/2047487312451539. Epub 2012 Jun 11.