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

Primary Purpose

Myocardial Infarction

Status
Completed
Phase
Not Applicable
Locations
Slovenia
Study Type
Interventional
Intervention
low-dose combination of fluvastatin (10 mg) and valsartan (20 mg) (low-flu/val)
placebo
Sponsored by
University Medical Centre Ljubljana
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Myocardial Infarction focused on measuring myocardial infarction, arterial stiffness, pulse wave velocity, flow mediated dilatation, fluvastatin, valsartan

Eligibility Criteria

undefined - 55 Years (Child, Adult)Male

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.

Sites / Locations

  • Department of Vascular Diseases, University Medical Centre Ljubljana

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Treatment group

Control group

Arm 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.

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
October 4, 2017
Last Updated
October 12, 2017
Sponsor
University Medical Centre Ljubljana
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1. Study Identification

Unique Protocol Identification Number
NCT03309618
Brief Title
Post- Myocardial Infarction Arterial Wall Improvement by Low-dose Fluvastatin and Valsartan
Official Title
Improving Arterial Wall Characteristics in Patients After Myocardial Infarction With a Very Low Dose of Fluvastatin and Valsartan: Proof-of-concept Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
November 2012 (Actual)
Primary Completion Date
November 2013 (Actual)
Study Completion Date
November 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Medical Centre Ljubljana

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myocardial Infarction
Keywords
myocardial infarction, arterial stiffness, pulse wave velocity, flow mediated dilatation, fluvastatin, valsartan

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment group
Arm Type
Experimental
Arm 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.
Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
16 participants received placebo per orally once daily for 30 days.
Intervention Type
Drug
Intervention Name(s)
low-dose combination of fluvastatin (10 mg) and valsartan (20 mg) (low-flu/val)
Intervention Type
Drug
Intervention Name(s)
placebo
Primary Outcome Measure Information:
Title
brachial flow mediated dilatation (FMD)
Description
ultrasonographically measured flow mediated dilatation of brachial artery
Time Frame
30 days
Title
carotid pulse wave velocity (c-PWV)
Description
ultrasonographically measured pulse wave velocity of carotid artery
Time Frame
30 days
Title
β-stiffness coefficient
Description
ultrasonographically measured β-stiffness coefficient of carotid artery
Time Frame
30 days
Title
carotid-femoral pulse wave velocity (cf-PWV)
Description
carotid-femoral pulse wave velocity measured by Sphygmocor
Time Frame
30 days
Title
reactive hyperemia index (RHI)
Description
reactive hyperemia index measured by an Endopat device
Time Frame
30 days
Secondary Outcome Measure Information:
Title
brachial flow mediated dilatation (FMD)
Description
ultrasonographically measured flow mediated dilatation of brachial artery
Time Frame
10 weeks after termination of intervention
Title
carotid pulse wave velocity (c-PWV)
Description
ultrasonographically measured pulse wave velocity of carotid artery
Time Frame
10 weeks after termination of intervention
Title
β-stiffness coefficient
Description
ultrasonographically measured β-stiffness coefficient of carotid artery
Time Frame
10 weeks after termination of intervention
Title
carotid-femoral pulse wave velocity (cf-PWV)
Description
carotid-femoral pulse wave velocity measured by Sphygmocor
Time Frame
10 weeks after termination of intervention
Title
reactive hyperemia index (RHI)
Description
reactive hyperemia index measured by an Endopat device
Time Frame
10 weeks after termination of intervention

10. Eligibility

Sex
Male
Maximum Age & Unit of Time
55 Years
Eligibility Criteria
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.
Facility Information:
Facility Name
Department of Vascular Diseases, University Medical Centre Ljubljana
City
Ljubljana
ZIP/Postal Code
SI-1000
Country
Slovenia

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
10913483
Citation
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Results Reference
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Citation
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Results Reference
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PubMed Identifier
10666353
Citation
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PubMed Identifier
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Citation
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PubMed Identifier
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Citation
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Results Reference
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PubMed Identifier
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Citation
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PubMed Identifier
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Citation
Lunder M, Janic M, Savic V, Janez A, Kanc K, Sabovic M. Very low-dose fluvastatin-valsartan combination decreases parameters of inflammation and oxidative stress in patients with type 1 diabetes mellitus. Diabetes Res Clin Pract. 2017 May;127:181-186. doi: 10.1016/j.diabres.2017.03.019. Epub 2017 Mar 22.
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Citation
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Citation
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Post- Myocardial Infarction Arterial Wall Improvement by Low-dose Fluvastatin and Valsartan

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