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OpenTrials
Completed

NCT Number: NCT03309618

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

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.

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Key information

Age range

Up to 55 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Department of Vascular Diseases, University Medical Centre Ljubljana

Ljubljana, SI-1000, Slovenia

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Drug

Placebo

Drug

Primary outcomes

  1. brachial flow mediated dilatation (FMD)

    Time frame: 30 days

    ultrasonographically measured flow mediated dilatation of brachial artery

  2. carotid pulse wave velocity (c-PWV)

    Time frame: 30 days

    ultrasonographically measured pulse wave velocity of carotid artery

  3. β-stiffness coefficient

    Time frame: 30 days

    ultrasonographically measured β-stiffness coefficient of carotid artery

  4. carotid-femoral pulse wave velocity (cf-PWV)

    Time frame: 30 days

    carotid-femoral pulse wave velocity measured by Sphygmocor

  5. reactive hyperemia index (RHI)

    Time frame: 30 days

    reactive hyperemia index measured by an Endopat device

Secondary outcomes

  1. brachial flow mediated dilatation (FMD)

    Time frame: 10 weeks after termination of intervention

    ultrasonographically measured flow mediated dilatation of brachial artery

  2. carotid pulse wave velocity (c-PWV)

    Time frame: 10 weeks after termination of intervention

    ultrasonographically measured pulse wave velocity of carotid artery

  3. β-stiffness coefficient

    Time frame: 10 weeks after termination of intervention

    ultrasonographically measured β-stiffness coefficient of carotid artery

  4. carotid-femoral pulse wave velocity (cf-PWV)

    Time frame: 10 weeks after termination of intervention

    carotid-femoral pulse wave velocity measured by Sphygmocor

  5. reactive hyperemia index (RHI)

    Time frame: 10 weeks after termination of intervention

    reactive hyperemia index measured by an Endopat device

Sponsors and collaborators

Lead sponsor

University Medical Centre Ljubljana

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2013
Study completion
2014
First posted
Oct 13, 2017
Registry last updated
Oct 16, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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