Post- Myocardial Infarction Arterial Wall Improvement by Low-dose Fluvastatin and Valsartan

Not Applicable

Completed

• Conditions: Myocardial Infarction
• Interventions: Drug: low-dose combination of fluvastatin (10 mg) and valsartan (20 mg) (low-flu/val); Drug: placebo

• Registration Number: NCT03309618
• Lead Sponsor: University Medical Centre Ljubljana

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-11
• Primary Completion: 2013-11
• Study Completion: 2014-11
• Status Verified: 2017-10
• Study First Submitted: 2017-10-04
• Study First Submitted QC: 2017-10-09
• Last Update Submitted: 2017-10-12
• Study First Posted: 2017-10-13
• Last Update Posted: 2017-10-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 36

Inclusion Criteria

• history of MI in the last 0.5 to 5 years
• males
• aged under 55 years

Exclusion Criteria

• diabetes mellitus
• manifest peripheral artery disease or carotid artery disease
• acute infection
• chronic diseases
• present therapy with fluvastatin and/or valsartan.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment group	low-dose combination of fluvastatin (10 mg) and valsartan (20 mg) (low-flu/val)	20 participants received low-dose combination of fluvastatin (10 mg) and valsartan (20 mg) (low-flu/val) per orally once daily for 30 days.
Control group	placebo	16 participants received placebo per orally once daily for 30 days.

Primary Outcome Measures

Name	Time	Method
brachial flow mediated dilatation (FMD)	30 days	ultrasonographically measured flow mediated dilatation of brachial artery
carotid pulse wave velocity (c-PWV)	30 days	ultrasonographically measured pulse wave velocity of carotid artery
β-stiffness coefficient	30 days	ultrasonographically measured β-stiffness coefficient of carotid artery
carotid-femoral pulse wave velocity (cf-PWV)	30 days	carotid-femoral pulse wave velocity measured by Sphygmocor
reactive hyperemia index (RHI)	30 days	reactive hyperemia index measured by an Endopat device

Secondary Outcome Measures

Name	Time	Method
brachial flow mediated dilatation (FMD)	10 weeks after termination of intervention	ultrasonographically measured flow mediated dilatation of brachial artery
carotid pulse wave velocity (c-PWV)	10 weeks after termination of intervention	ultrasonographically measured pulse wave velocity of carotid artery
β-stiffness coefficient	10 weeks after termination of intervention	ultrasonographically measured β-stiffness coefficient of carotid artery
carotid-femoral pulse wave velocity (cf-PWV)	10 weeks after termination of intervention	carotid-femoral pulse wave velocity measured by Sphygmocor
reactive hyperemia index (RHI)	10 weeks after termination of intervention	reactive hyperemia index measured by an Endopat device

Trial Locations

Locations (1)

Department of Vascular Diseases, University Medical Centre Ljubljana; 🇸🇮 Ljubljana, Slovenia