Back to resultsEffects of Pitavastatin on Monocyte, Endothelial Dysfunction and HDL-C in Subjects With Metabolic Syndrome (CAPITAIN)
Primary Purpose
Metabolic Syndrome
Status
Completed
Phase
Phase 1
Locations
United Kingdom
Study Type
Interventional
Intervention
Pitavastatin
Sponsored by
About this trial
This is an interventional treatment trial for Metabolic Syndrome
Eligibility Criteria
Inclusion Criteria:
- Patients with metabolic syndrome
- Patients with LDL-C > 130mg/dL
- Eligible, able to participate and have given informed consent
Exclusion Criteria:
- 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
Sites / Locations
- Kowa Research Europe Ltd.
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Pitavastatin 4mg daily
Arm Description
4 mg tablets of pitavastatin by oral route for a period of 6 months
Outcomes
Primary Outcome Measures
Change from baseline to Day 180 in plasma biomarkers of inflammation and atherosclerosis, including monocytes, lymphocytes, endothelial adhesion proteins, atherogenic lipoproteins and cardioprotective HDL
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01595828
Brief Title
Effects of Pitavastatin on Monocyte, Endothelial Dysfunction and HDL-C in Subjects With Metabolic Syndrome
Acronym
CAPITAIN
Official Title
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)
Study Type
Interventional
2. Study Status
Record Verification Date
July 2013
Overall Recruitment Status
Completed
Study Start Date
October 2010 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
June 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kowa Research Europe
4. Oversight
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
14 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Pitavastatin 4mg daily
Arm Type
Experimental
Arm Description
4 mg tablets of pitavastatin by oral route for a period of 6 months
Intervention Type
Drug
Intervention Name(s)
Pitavastatin
Primary Outcome Measure Information:
Title
Change from baseline to Day 180 in plasma biomarkers of inflammation and atherosclerosis, including monocytes, lymphocytes, endothelial adhesion proteins, atherogenic lipoproteins and cardioprotective HDL
Time Frame
180 days
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with metabolic syndrome
Patients with LDL-C > 130mg/dL
Eligible, able to participate and have given informed consent
Exclusion Criteria:
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
Facility Information:
Facility Name
Kowa Research Europe Ltd.
City
Wokingham
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
35695616
Citation
Therond 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.
Results Reference
derived
PubMed Identifier
32295829
Citation
Chapman 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.
Results Reference
derived
PubMed Identifier
29574070
Citation
Chapman 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.
Results Reference
derived
PubMed Identifier
27581680
Citation
Orsoni 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.
Results Reference
derived
PubMed Identifier
26486974
Citation
Meikle 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.
Results Reference
derived
PubMed Identifier
24328357
Citation
Chapman 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.
Results Reference
derived
Learn more about this trial
Effects of Pitavastatin on Monocyte, Endothelial Dysfunction and HDL-C in Subjects With Metabolic Syndrome
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