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Pitavastatin on Carotid Intima-media Thickness (PEACE)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2009 by Kyoto Prefectural University of Medicine.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Kyoto Prefectural University of Medicine
ClinicalTrials.gov Identifier:
NCT00711919
First received: July 7, 2008
Last updated: September 9, 2009
Last verified: September 2009
History of Changes
  Purpose

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 Intervention
Hyperlipidemia
Carotid Artery Diseases
 Drug: Pitavastatin

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Pitavastatin Evaluation of Atherosclerosis Regression by Intensive Cholesterol-Lowering Therapy

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Kyoto Prefectural University of Medicine:

Primary Outcome Measures:
  • absolute changes in carotid intima-media thickness from baseline to final visit [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • relative change in carotid intima-media thickness [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • change in LDL-C, HDL-C, TG and RLP-C [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • change in hs-CRP and IL-6 [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • new onset or recurrence of ischemic heart disease, heart failure, stroke and atherosclerosis obliterans [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • sudden death [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • side effects [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 300
Study Start Date: July 2007
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Hiroaki Matsubara, Kyoto Prefectural University of Medicine
ClinicalTrials.gov Identifier: NCT00711919     History of Changes
Other Study ID Numbers: C-255, UMIN000001229
Study First Received: July 7, 2008
Last Updated: September 9, 2009
Health Authority: Japan: Institutional Review Board

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

ClinicalTrials.gov processed this record on June 18, 2013