PEACE: Pitavastatin on Carotid Intima-media Thickness

Sponsor

Kyoto Prefectural University of Medicine (Other)

Overall Status

Unknown status

CT.gov ID

NCT00711919

Collaborator

(none)

300

Enrollment

Locations

Arms

16.7

Patients Per Site

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hyperlipidemia Carotid Artery Diseases	Drug: Pitavastatin Drug: Pitavastatin	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

300 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Pitavastatin Evaluation of Atherosclerosis Regression by Intensive Cholesterol-Lowering Therapy

Study Start Date :

Jul 1, 2007

Anticipated Primary Completion Date :

Dec 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 1 Subjects are receiving Pitavastatin, starting at 2 mg, for 12 months. After administration, serum LDL-cholesterol should be kept between 100 and 80 mg/dL by controlling the dose of Pitavastatin or adding other anti-hyperlipidemia agents other than statins.	Drug: Pitavastatin comparison of different target levels of lipid lowering using Pitavastatin Subjects are receiving Pitavastatin, starting at 2 mg, for 12 months.
Active Comparator: 2 Subjects are receiving Pitavastatin, starting at 4 mg, for 12 months. After administration, serum LDL-cholesterol should be kept under 80 mg/dL by controlling the dose of Pitavastatin or adding other anti-hyperlipidemia agents other than statins.	Drug: Pitavastatin Subjects are receiving Pitavastatin, starting at 4 mg, for 12 months.

Arm

Intervention/Treatment

Active Comparator: 1

Subjects are receiving Pitavastatin, starting at 2 mg, for 12 months. After administration, serum LDL-cholesterol should be kept between 100 and 80 mg/dL by controlling the dose of Pitavastatin or adding other anti-hyperlipidemia agents other than statins.

Drug: Pitavastatin

comparison of different target levels of lipid lowering using Pitavastatin Subjects are receiving Pitavastatin, starting at 2 mg, for 12 months.

Active Comparator: 2

Subjects are receiving Pitavastatin, starting at 4 mg, for 12 months. After administration, serum LDL-cholesterol should be kept under 80 mg/dL by controlling the dose of Pitavastatin or adding other anti-hyperlipidemia agents other than statins.

Drug: Pitavastatin

Subjects are receiving Pitavastatin, starting at 4 mg, for 12 months.

Outcome Measures

Primary Outcome Measures

absolute changes in carotid intima-media thickness from baseline to final visit [12 months]

Secondary Outcome Measures

relative change in carotid intima-media thickness [12 months]
change in LDL-C, HDL-C, TG and RLP-C [12 months]
change in hs-CRP and IL-6 [12 months]
new onset or recurrence of ischemic heart disease, heart failure, stroke and atherosclerosis obliterans [12 months]
sudden death [12 months]
side effects [12 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ayabe City Hospital	Ayabe	Kyoto	Japan	623-0011
2	Fukuchiyama City Hospital	Fukuchiyama	Kyoto	Japan	620-8505
3	Tanabe Central Hospital	Kyotanabe	Kyoto	Japan	610-0334
4	Kumihama Hospital	Kyotango	Kyoto	Japan	629-3400
5	Maizuru Medical Center	Maizuru	Kyoto	Japan	625-8502
6	Maizuru Kyosai Hospital	Maizuru	Kyoto	Japan	625-8585
7	Saiseikai Kyoto Hospital	Nagaokakyo	Kyoto	Japan	617-0814
8	Nantan General Hospital	Nantan	Kyoto	Japan	629-0197
9	Meiji University of Integrative Medicine Hospital	Nantan	Kyoto	Japan	629-0392
10	Gakken Toshi Hospital	Seika	Kyoto	Japan	619-0238
11	Uji Hospital	Uji	Kyoto	Japan	611-0011
12	Kyoto Prefectural Yosanoumi Hospital	Yosano	Kyoto	Japan	629-2261
13	Shiga Hospital	Higashioumi	Shiga	Japan	527-8505
14	Omihachiman Community Medical Center	Omihachiman	Shiga	Japan	523-0082
15	Saiseikai Shigaken Hospital	Rittou	Shiga	Japan	520-3046
16	Takeda Hospital	Kyoto		Japan	600-8558
17	Kyoto Prefectural University of Medicine	Kyoto		Japan	602-8566
18	Kyoto First Red Cross Hospital	Kyoto		Japan	605-0981

Sponsors and Collaborators

Kyoto Prefectural University of Medicine

Investigators

Study Chair: Hiroaki Matsubara, MD, PhD, Kyoto Prefectural University of Medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT00711919

Other Study ID Numbers:

C-255
UMIN000001229

First Posted:

Jul 9, 2008

Last Update Posted:

Sep 10, 2009

Last Verified:

Sep 1, 2009

Additional relevant MeSH terms:

Carotid Artery Diseases

Hyperlipidemias

Pitavastatin

Study Results

No Results Posted as of Sep 10, 2009