Effects of Pitavastatin on Monocyte, Endothelial Dysfunction and HDL-C in Subjects With Metabolic Syndrome (CAPITAIN)

• ClinicalTrials.gov Identifier: NCT01595828
• Recruitment Status: Completed
• First Posted: May 10, 2012
• Last Update Posted: July 22, 2013
• Sponsor: Kowa Research Europe
• Information provided by (Responsible Party): Kowa Research Europe

Tracking Information

• First Submitted Date: May 2, 2012
• First Posted Date: May 10, 2012
• Last Update Posted Date: July 22, 2013
• Study Start Date: October 2010
• Actual Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: July 19, 2013): 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 ]
• Original Primary Outcome Measures (submitted: May 8, 2012): Change from baseline to Day 180 in plasma biomarkers of inflammation and atherosclerosis, including monocytes, lymphocytes, endothelial adhesion proteins, atherogenic lipoproteins and cardioprotective HDL
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Effects of Pitavastatin on Monocyte, Endothelial Dysfunction and HDL-C in Subjects With Metabolic Syndrome
• 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)
• 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).
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 1
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Metabolic Syndrome
• Intervention: Drug: Pitavastatin

Study Arms

Experimental: Pitavastatin 4mg daily

4 mg tablets of pitavastatin by oral route for a period of 6 months

Intervention: Drug: Pitavastatin

Publications *

• Chapman MJ, Orsoni A, Tan R, Mellett NA, Nguyen A, Robillard P, Giral P, Thérond 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.
• 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.
• Orsoni A, Thérond 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. Epub 2016 Aug 31.
• 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.
• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: July 19, 2013): 14
• Original Estimated Enrollment (submitted: May 8, 2012): 20
• Actual Study Completion Date: June 2012
• Actual Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: Male

• Ages: 30 Years to 65 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United Kingdom

Administrative Information

• NCT Number: NCT01595828
• Other Study ID Numbers: NK-104-4.03EU
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Kowa Research Europe
• Study Sponsor: Kowa Research Europe
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Kowa Research Europe
• Verification Date: July 2013