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

University Medical Centre Ljubljana

Status: Completed

Conditions: Myocardial Infarction

Treatments: Drug: low-dose combination of fluvastatin (10 mg) and valsartan (20 mg) (low-flu/val); Drug: placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT03309618

AGE-MI

Details and patient eligibility

About

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.

Enrollment: 36 patients

Sex: Male

Ages: Under 55 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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36 participants in 2 patient groups, including a placebo group

Treatment group

Experimental group

Description:

20 participants received low-dose combination of fluvastatin (10 mg) and valsartan (20 mg) (low-flu/val) per orally once daily for 30 days.

Treatment:

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

Control group

Placebo Comparator group

Description:

16 participants received placebo per orally once daily for 30 days.

Treatment:

Drug: placebo