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

October 12, 2017 updated by: Martina Turk Veselič, University Medical Centre Ljubljana

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

36

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Slovenia
      • Ljubljana, Slovenia, SI-1000
        • Department of Vascular Diseases, University Medical Centre Ljubljana

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 55 years (Child, Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Medical Centre Ljubljana

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2012

Primary Completion (Actual)

November 1, 2013

Study Completion (Actual)

November 1, 2014

Study Registration Dates

First Submitted

October 4, 2017

First Submitted That Met QC Criteria

October 9, 2017

First Posted (Actual)

October 13, 2017

Study Record Updates

Last Update Posted (Actual)

October 16, 2017

Last Update Submitted That Met QC Criteria

October 12, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AGE-MI

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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