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

Study Overview
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Brief Summary
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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.

Official Title
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Improving Arterial Wall Characteristics in Patients After Myocardial Infarction With a Very Low Dose of Fluvastatin and Valsartan: Proof-of-concept Study

Conditions
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Myocardial Infarction

Intervention / Treatment
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* Drug: low-dose combination of fluvastatin (10 mg) and valsartan (20 mg) (low-flu/val)
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Maximum Age: 55 Years

Sexes Eligible for Study
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Male

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment group<br>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)<br> <br> |
| Placebo Comparator: Control group<br>16 participants received placebo per orally once daily for 30 days. | Drug: placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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myocardial infarction, arterial stiffness, pulse wave velocity, flow mediated dilatation, fluvastatin, valsartan