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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03309618

Enrollment

Registered

2017-10-13

Start date

2012-11-30

Completion date

2014-11-30

Last updated

2017-10-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myocardial Infarction

Keywords

myocardial infarction, arterial stiffness, pulse wave velocity, flow mediated dilatation, fluvastatin, valsartan

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.

Interventions

DRUGlow-dose combination of fluvastatin (10 mg) and valsartan (20 mg) (low-flu/val)

DRUGplacebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

MALE

Age

No minimum to 55 Years

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.

Design outcomes

Primary

Measure	Time frame	Description
reactive hyperemia index (RHI)	30 days	reactive hyperemia index measured by an Endopat device
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

Secondary

Measure	Time frame	Description
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

Countries

Slovenia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026