Biomarker Sub-study to the VYTUL Study

• Register: ANZCTR
• Last refreshed on: 13 January 2020
• Main ID: ACTRN12606000377538
• Date of registration: 29/08/2006
• Prospective Registration: Yes
• Primary sponsor: Deartment of Epidemiology and Preventive Medicine CCRE in Therapeutics Monash University
• Public title: Biomarker Sub-study to the VYTUL Study
• Scientific title: A comparison of the Effects of Vytorin (Ezetimibe and Simvastatin) versus Lipitor (Atorvastatin) in inducing changes to levels of novel serum biomarkers associated with Coronary Heart Disease risk.
• Date of first enrolment: 01/09/2006
• Target sample size: 550
• Recruitment status: Completed
• URL: https://anzctr.org.au/ACTRN12606000377538.aspx
• Study type: Interventional
• Study design: Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Open (masking not used);Assignment: Parallel;Type of endpoint: Efficacy;

Countries of recruitment

Australia

Contacts

• Name: Ms Louise Shiel - Project Manager

• Name: Associate Professor Chris Reid - Co principal investigator

Key inclusion & exclusion criteria

Inclusion criteria: Participation in the VYTUL study- Capable of and willing to sign written informed consent- Has been treated for at least the last 3 months with a daily dose of atorvastatin40 mg- Existing coronary heart disease and has cholesterol > 4.0 mmol/L measured at Visit 1 OR diabetes mellitus and has measured at Visit 1• cholesterol > 6.5 mmol/L OR• cholesterol > 5.5 mmol/L and HDL < 1 mmol/L- Free of any clinically significant diseases, other than hyperlipidaemia, that would interfere with study evaluations and willing and able to attend all study visits.
Exclusion criteria: Uncontrolled diabetes, defined by a measured HbA1c > 9% as measured at Visit 1-Has alanine aminotransferase (ALT) > 1.5 times Upper Limit of Normal (ULN) as measured at Visit 1- Has aspartate aminotransferase (AST) > 1.5 times ULN as measured at Visit 1-Has creatine kinase (CK) > 1.5 times ULN as measured at Visit 1- Has triglycerides (TG) > 4.5 mmol/L as measured at Visit 1- Has evidence of renal impairment with a serum creatinine > 200 µmol/L as measured at Visit 1- Has known drug or alcohol dependency within 6 months prior to Visit 1-A woman receiving hormonal therapy, including hormone replacement, anyestrogen antagonist/agonist, or oral contraceptives, who have not beenmaintained on a stable dose and regimen for at least 8 weeks and are willingto continue the same regimen for the duration of the study.- A woman of childbearing potential (includes women who are less than 1 yearpostmenopausal or not surgically sterile) not using an acceptable method of birth control (e.g., hormonal contraceptive, medically prescribed IUD, condomin combination with spermicide)- Women who are pregnant or breast feeding- Any condition or situation which, in the opinion of the investigator, might pose arisk to the subject or interfere with participation in the studyProhibited Medication for the Duration of the Study- Medications taken within 5 weeks prior to Visit 1 (Screening Visit) including: macrolide antibiotics, azole antifungals, fibric acid derivatives, niacin- Other medication as listed in the product information sheets for ezetimibe/simvastatin and atorvastatin.

Age minimum: 18 Years
Age maximum: Not stated
Gender: Both males and females

Health Condition(s) or Problem(s) studied

Blood - Other blood disorders

Hypercholesterolaemia;
Hypercholesterolaemia

Intervention(s)

Oral administration of Vytorin 10/40 (Ezetimibe 10 mg and Simvastatin 40 mg) intervention group

Primary Outcome(s)

To determine and compare the effects of Vytorin 10/40 to Atorvastatin 80 daily on cardiovascular risk profile as indicated by changes to the levels of each of the following risk biomarkers: Lipoprotein-associated phospholipase A2 (Lp-PLA2)[At a single time point after 6 weeks of treatment]

To determine and compare the effects of Vytorin 10/40 to Atorvastatin 80 daily on cardiovascular risk profile as indicated by changes to the levels of each of the following risk biomarkers: Oxidised low density lipoprotein (oxLDL)[At a single time point after 6 weeks of treatment]

To determine and compare the effects of Vytorin 10/40 to Atorvastatin 80 daily on cardiovascular risk profile as indicated by changes to the levels of each of the following risk biomarkers: Tumour Necrosis Factor alpha (TNFa).[At a single time point after 6 weeks of treatment]

To determine and compare the effects of Vytorin 10/40 to Atorvastatin 80 daily on cardiovascular risk profile as indicated by changes to the levels of each of the following risk biomarkers: B-Type Natriuretic Peptide (BNP)[At a single time point after 6 weeks of treatment]

To determine and compare the effects of Vytorin 10/40 to Atorvastatin 80 daily on cardiovascular risk profile as indicated by changes to the levels of each of the following risk biomarkers: C Reactive Protein (CRP)[At a single time point after 6 weeks of treatment]

To determine and compare the effects of Vytorin 10/40 to Atorvastatin 80 daily on cardiovascular risk profile as indicated by changes to the levels of each of the following risk biomarkers: Matrix Metalloproteinase (MMP)[At a single time point after 6 weeks of treatment]

Secondary Outcome(s)

To explore non-physiological external issues such as participant awareness of their health and its management and any perceived barriers to health care that may contribute to ineffective risk factor modification.[This will be performed at the screening visit before cholesterol testing is performed and before treatment .]

Source(s) of Monetary Support

Department of Epidemilogy and Preventive Medicine CCRE in Therapeutics Monash University

Ethics review

Status: Approved
Approval date:
Contact:

Monash University Clinical Trials Centre Caulfield General Medical Centre