Effects of Pitavastatin on Monocyte, Endothelial Dysfunction and HDL-C in Subjects With Metabolic Syndrome
CAPITAIN
An Open Label Study of the Chronic and Acute Effects of Pitavastatin on Monocyte Phenotype, Endothelial Dysfunction and HDL Atheroprotective Function in Subjects With Metabolic Syndrome (CAPITAIN)
1 other identifier
interventional
14
1 country
1
Brief Summary
The purpose of this study is to examine in detail the acute and chronic effects of pitavastatin on plasma lipid transport and atheroma biomarkers in patients at elevated risk for the premature development of atherosclerosis (CAPITAIN).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Oct 2010
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2010
CompletedFirst Submitted
Initial submission to the registry
May 2, 2012
CompletedFirst Posted
Study publicly available on registry
May 10, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2012
CompletedJuly 22, 2013
July 1, 2013
1.7 years
May 2, 2012
July 19, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
Change from baseline to Day 180 in plasma biomarkers of inflammation and atherosclerosis, including monocytes, lymphocytes, endothelial adhesion proteins, atherogenic lipoproteins and cardioprotective HDL
180 days
Study Arms (1)
Pitavastatin 4mg daily
EXPERIMENTAL4 mg tablets of pitavastatin by oral route for a period of 6 months
Interventions
Eligibility Criteria
You may qualify if:
- Patients with metabolic syndrome
- Patients with LDL-C \> 130mg/dL
- Eligible, able to participate and have given informed consent
You may not qualify if:
- Body Mass Index \>35 kg/m2
- LDL-C \> 190mg/dL
- Fasting triglycerides \> 400 mg/dL
- Diabetes mellitus (fasting glucose \>7 mmol/L) or taking diabetic therapy
- Uncontrolled hypertension (Systolic Blood Pressure \>= 140 mmHg or Diastolic Blood Pressure \>= 90mmHg)
- Any conditions that cause secondary dyslipidaemia or increase the risk of statin therapy
- ALAT and ASAT \>3 x ULRR
- Impaired renal function (Serum Creatinine \>1.5 x ULRR or eGFR \<60 mL/min)
- History of any muscle disease or unexplained elevation (\>3 x ULRR) of serum creatine kinase
- Evidence of symptomatic heart failure (NYHA class III or IV)
- Current or recent user of supplements or medications known to alter lipid metabolism
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Kowa Research Europe Ltd.
Wokingham, United Kingdom
Related Publications (7)
Chapman MJ, Orsoni A, Mellett NA, Nguyen A, Robillard P, Shaw JE, Giral P, Therond P, Swertfeger D, Davidson WS, Meikle PJ. Pitavastatin treatment remodels the HDL subclass lipidome and proteome in hypertriglyceridemia. J Lipid Res. 2024 Feb;65(2):100494. doi: 10.1016/j.jlr.2023.100494. Epub 2023 Dec 29.
PMID: 38160756DERIVEDTherond P, Chapman MJ. Sphingosine-1-phosphate: metabolism, transport, atheroprotection and effect of statin treatment. Curr Opin Lipidol. 2022 Jun 1;33(3):199-207. doi: 10.1097/MOL.0000000000000825. Epub 2022 Mar 9.
PMID: 35695616DERIVEDChapman MJ, Orsoni A, Tan R, Mellett NA, Nguyen A, Robillard P, Giral P, Therond P, Meikle PJ. LDL subclass lipidomics in atherogenic dyslipidemia: effect of statin therapy on bioactive lipids and dense LDL. J Lipid Res. 2020 Jun;61(6):911-932. doi: 10.1194/jlr.P119000543. Epub 2020 Apr 15.
PMID: 32295829DERIVEDChapman MJ, Orsoni A, Robillard P, Therond P, Giral P. Duality of statin action on lipoprotein subpopulations in the mixed dyslipidemia of metabolic syndrome: Quantity vs quality over time and implication of CETP. J Clin Lipidol. 2018 May-Jun;12(3):784-800.e4. doi: 10.1016/j.jacl.2018.02.001. Epub 2018 Feb 9.
PMID: 29574070DERIVEDOrsoni A, Therond P, Tan R, Giral P, Robillard P, Kontush A, Meikle PJ, Chapman MJ. Statin action enriches HDL3 in polyunsaturated phospholipids and plasmalogens and reduces LDL-derived phospholipid hydroperoxides in atherogenic mixed dyslipidemia. J Lipid Res. 2016 Nov;57(11):2073-2087. doi: 10.1194/jlr.P068585. Epub 2016 Aug 31.
PMID: 27581680DERIVEDMeikle PJ, Wong G, Tan R, Giral P, Robillard P, Orsoni A, Hounslow N, Magliano DJ, Shaw JE, Curran JE, Blangero J, Kingwell BA, Chapman MJ. Statin action favors normalization of the plasma lipidome in the atherogenic mixed dyslipidemia of MetS: potential relevance to statin-associated dysglycemia. J Lipid Res. 2015 Dec;56(12):2381-92. doi: 10.1194/jlr.P061143. Epub 2015 Oct 20.
PMID: 26486974DERIVEDChapman MJ, Orsoni A, Robillard P, Hounslow N, Sponseller CA, Giral P. Effect of high-dose pitavastatin on glucose homeostasis in patients at elevated risk of new-onset diabetes: insights from the CAPITAIN and PREVAIL-US studies. Curr Med Res Opin. 2014 May;30(5):775-84. doi: 10.1185/03007995.2013.874989. Epub 2014 Jan 10.
PMID: 24328357DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 2, 2012
First Posted
May 10, 2012
Study Start
October 1, 2010
Primary Completion
June 1, 2012
Study Completion
June 1, 2012
Last Updated
July 22, 2013
Record last verified: 2013-07