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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03309618
Recruitment Status : Completed
First Posted : October 13, 2017
Last Update Posted : October 16, 2017
Sponsor:
Information provided by (Responsible Party):
Martina Turk Veselič, University Medical Centre Ljubljana

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.

Condition or disease Intervention/treatment Phase
Myocardial Infarction Drug: low-dose combination of fluvastatin (10 mg) and valsartan (20 mg) (low-flu/val) Drug: placebo Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Improving Arterial Wall Characteristics in Patients After Myocardial Infarction With a Very Low Dose of Fluvastatin and Valsartan: Proof-of-concept Study
Actual Study Start Date : November 2012
Actual Primary Completion Date : November 2013
Actual Study Completion Date : November 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack

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



Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   up to 55 Years   (Child, Adult)
Sexes Eligible for Study:   Male
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03309618


Locations
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Slovenia
Department of Vascular Diseases, University Medical Centre Ljubljana
Ljubljana, Slovenia, SI-1000
Sponsors and Collaborators
University Medical Centre Ljubljana
Publications:

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Responsible Party: Martina Turk Veselič, Principal Investigator, M.D., University Medical Centre Ljubljana
ClinicalTrials.gov Identifier: NCT03309618    
Other Study ID Numbers: AGE-MI
First Posted: October 13, 2017    Key Record Dates
Last Update Posted: October 16, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Martina Turk Veselič, University Medical Centre Ljubljana:
myocardial infarction
arterial stiffness
pulse wave velocity
flow mediated dilatation
fluvastatin
valsartan
Additional relevant MeSH terms:
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Myocardial Infarction
Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Valsartan
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action