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Pitavastatin on Carotid Intima-media Thickness (PEACE)

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ClinicalTrials.gov Identifier: NCT00711919
Recruitment Status : Unknown
Verified September 2009 by Kyoto Prefectural University of Medicine.
Recruitment status was:  Active, not recruiting
First Posted : July 9, 2008
Last Update Posted : September 10, 2009
Sponsor:
Information provided by:

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
Hyperlipidemia Carotid Artery Diseases Drug: Pitavastatin

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated 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 : July 2007
Estimated Primary Completion Date : December 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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.


Outcome Measures

Primary Outcome Measures :
  1. absolute changes in carotid intima-media thickness from baseline to final visit [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. relative change in carotid intima-media thickness [ Time Frame: 12 months ]
  2. change in LDL-C, HDL-C, TG and RLP-C [ Time Frame: 12 months ]
  3. change in hs-CRP and IL-6 [ Time Frame: 12 months ]
  4. new onset or recurrence of ischemic heart disease, heart failure, stroke and atherosclerosis obliterans [ Time Frame: 12 months ]
  5. sudden death [ Time Frame: 12 months ]
  6. side effects [ Time Frame: 12 months ]

Eligibility Criteria

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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00711919


Locations
Japan
Ayabe City Hospital
Ayabe, Kyoto, Japan, 623-0011
Fukuchiyama City Hospital
Fukuchiyama, Kyoto, Japan, 620‐8505
Tanabe Central Hospital
Kyotanabe, Kyoto, Japan, 610-0334
Kumihama Hospital
Kyotango, Kyoto, Japan, 629-3400
Maizuru Medical Center
Maizuru, Kyoto, Japan, 625-8502
Maizuru Kyosai Hospital
Maizuru, Kyoto, Japan, 625-8585
Saiseikai Kyoto Hospital
Nagaokakyo, Kyoto, Japan, 617-0814
Nantan General Hospital
Nantan, Kyoto, Japan, 629-0197
Meiji University of Integrative Medicine Hospital
Nantan, Kyoto, Japan, 629-0392
Gakken Toshi Hospital
Seika, Kyoto, Japan, 619-0238
Uji Hospital
Uji, Kyoto, Japan, 611-0011
Kyoto Prefectural Yosanoumi Hospital
Yosano, Kyoto, Japan, 629-2261
Shiga Hospital
Higashioumi, Shiga, Japan, 527-8505
Omihachiman Community Medical Center
Omihachiman, Shiga, Japan, 523-0082
Saiseikai Shigaken Hospital
Rittou, Shiga, Japan, 520-3046
Takeda Hospital
Kyoto, Japan, 600-8558
Kyoto Prefectural University of Medicine
Kyoto, Japan, 602-8566
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
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Hiroaki Matsubara, Kyoto Prefectural University of Medicine
ClinicalTrials.gov Identifier: NCT00711919     History of Changes
Other Study ID Numbers: C-255
UMIN000001229
First Posted: July 9, 2008    Key Record Dates
Last Update Posted: September 10, 2009
Last Verified: September 2009

Additional relevant MeSH terms:
Hyperlipidemias
Hyperlipoproteinemias
Carotid Artery Diseases
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pitavastatin
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Lipid Regulating Agents