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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

Tracking Information
First Submitted Date  ICMJE October 4, 2017
First Posted Date  ICMJE October 13, 2017
Last Update Posted Date October 16, 2017
Actual Study Start Date  ICMJE November 2012
Actual Primary Completion Date November 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 9, 2017)
  • brachial flow mediated dilatation (FMD) [ Time Frame: 30 days ]
    ultrasonographically measured flow mediated dilatation of brachial artery
  • carotid pulse wave velocity (c-PWV) [ Time Frame: 30 days ]
    ultrasonographically measured pulse wave velocity of carotid artery
  • β-stiffness coefficient [ Time Frame: 30 days ]
    ultrasonographically measured β-stiffness coefficient of carotid artery
  • carotid-femoral pulse wave velocity (cf-PWV) [ Time Frame: 30 days ]
    carotid-femoral pulse wave velocity measured by Sphygmocor
  • reactive hyperemia index (RHI) [ Time Frame: 30 days ]
    reactive hyperemia index measured by an Endopat device
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 9, 2017)
  • brachial flow mediated dilatation (FMD) [ Time Frame: 10 weeks after termination of intervention ]
    ultrasonographically measured flow mediated dilatation of brachial artery
  • carotid pulse wave velocity (c-PWV) [ Time Frame: 10 weeks after termination of intervention ]
    ultrasonographically measured pulse wave velocity of carotid artery
  • β-stiffness coefficient [ Time Frame: 10 weeks after termination of intervention ]
    ultrasonographically measured β-stiffness coefficient of carotid artery
  • carotid-femoral pulse wave velocity (cf-PWV) [ Time Frame: 10 weeks after termination of intervention ]
    carotid-femoral pulse wave velocity measured by Sphygmocor
  • reactive hyperemia index (RHI) [ Time Frame: 10 weeks after termination of intervention ]
    reactive hyperemia index measured by an Endopat device
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Post- Myocardial Infarction Arterial Wall Improvement by Low-dose Fluvastatin and Valsartan
Official Title  ICMJE Improving Arterial Wall Characteristics in Patients After Myocardial Infarction With a Very Low Dose of Fluvastatin and Valsartan: Proof-of-concept Study
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Myocardial Infarction
Intervention  ICMJE
  • Drug: low-dose combination of fluvastatin (10 mg) and valsartan (20 mg) (low-flu/val)
  • Drug: placebo
Study Arms  ICMJE
  • 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.
    Intervention: 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.
    Intervention: Drug: placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 9, 2017)
36
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 2014
Actual Primary Completion Date November 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE up to 55 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE Not Provided
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Slovenia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03309618
Other Study ID Numbers  ICMJE AGE-MI
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Martina Turk Veselič, University Medical Centre Ljubljana
Study Sponsor  ICMJE University Medical Centre Ljubljana
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University Medical Centre Ljubljana
Verification Date October 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP