An interventional study of low-dose combination of fluvastatin (10 mg) and valsartan (20 mg) (low-flu/val) and placebo in Myocardial Infarction, sponsored by University Medical Centre Ljubljana. Completed at 1 site in Slovenia. Open to male participants aged Up to 55 Years. Per ClinicalTrials.gov, last updated 2017-10-16.
Sponsored by University Medical Centre Ljubljana · Not applicable, Interventional, and Prevention
The concept of improving arterial wall characteristics by treatment with a very low-dose combination of fluvastatin and valsartan (low-flu/val) in stable, post-myocardial infarction (MI) patients was tested. The parameters of endothelial function (flow mediated dilatation (FMD), reactive hyperemia index) and arterial stiffness (carotid-femoral pulse wave velocity (cf-PWV), local carotid PWV and β-stiffness coefficient) were measured before and after 30 days of treatment, and the residual effect was assessed 10 weeks later. So the investigators explored whether low-flu/val added "on-top-of" optimal therapy could improve endothelial function and arterial stiffness in post-MI patients. Since these improved parameters are well-known predictors of future coronary events, such treatment could decrease cardiovascular risk.
Exclusion Criteria:
20 participants received low-dose combination of fluvastatin (10 mg) and valsartan (20 mg) (low-flu/val) per orally once daily for 30 days.
Drug: low-dose combination of fluvastatin (10 mg) and valsartan (20 mg) (low-flu/val)
16 participants received placebo per orally once daily for 30 days.
Drug: placebo
brachial flow mediated dilatation (FMD)
ultrasonographically measured flow mediated dilatation of brachial artery
Time frame: 30 days
carotid pulse wave velocity (c-PWV)
ultrasonographically measured pulse wave velocity of carotid artery
Time frame: 30 days
β-stiffness coefficient
ultrasonographically measured β-stiffness coefficient of carotid artery
Time frame: 30 days
carotid-femoral pulse wave velocity (cf-PWV)
carotid-femoral pulse wave velocity measured by Sphygmocor
Time frame: 30 days
reactive hyperemia index (RHI)
reactive hyperemia index measured by an Endopat device
Time frame: 30 days
brachial flow mediated dilatation (FMD)
ultrasonographically measured flow mediated dilatation of brachial artery
Time frame: 10 weeks after termination of intervention
carotid pulse wave velocity (c-PWV)
ultrasonographically measured pulse wave velocity of carotid artery
Time frame: 10 weeks after termination of intervention
β-stiffness coefficient
ultrasonographically measured β-stiffness coefficient of carotid artery
Time frame: 10 weeks after termination of intervention
carotid-femoral pulse wave velocity (cf-PWV)
carotid-femoral pulse wave velocity measured by Sphygmocor
Time frame: 10 weeks after termination of intervention
reactive hyperemia index (RHI)
reactive hyperemia index measured by an Endopat device
Time frame: 10 weeks after termination of intervention
Plan to share: No
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University Medical Centre Ljubljana