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AzTrials

Myocardial InfarctionNCT03309618

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

A study testing low-dose combination of fluvastatin (10 mg) and valsartan (20 mg) (low-flu/val) in people with Myocardial Infarction, run by University Medical Centre Ljubljana at 1 site in Slovenia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages Up to 55 years, men only
Conditions the study is for
Myocardial Infarction
What is being tested?
low-dose combination of fluvastatin (10 mg) and valsartan (20 mg) (low-flu/val)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
36 participants
Where
1 siteSlovenia
Study dates
Nov 2012to Nov 2014
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Up to 55 years
  • Men only
  • Child, Adult

Who may be able to join

  • history of MI in the last 0.5 to 5 years
  • males
  • aged under 55 years

Who cannot join

  • diabetes mellitus
  • manifest peripheral artery disease or carotid artery disease
  • acute infection
  • chronic diseases
  • present therapy with fluvastatin and/or valsartan.

Trial locations and contacts

1 site in 1 country.

Slovenia1 site

  • Department of Vascular Diseases, University Medical Centre Ljubljana

    Ljubljana, SI-1000

Other trials in Slovenia

About this study

Official title: 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.

Being tested
low-dose combination of fluvastatin (10 mg) and valsartan (20 mg) (low-flu/val), placebo
Keywords
myocardial infarction, arterial stiffness, pulse wave velocity, flow mediated dilatation, fluvastatin, valsartan
Medical subject headings
Myocardial Infarction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

  • placeboDrug

Study groups in NCT03309618
Study groupRoleWhat they receive
Treatment groupExperimental20 participants received low-dose combination of fluvastatin (10 mg) and valsartan (20 mg) (low-flu/val) per orally once daily for 30 days.
Receives: Drug: low-dose combination of fluvastatin (10 mg) and valsartan (20 mg) (low-flu/val)
Control groupPlacebo comparator16 participants received placebo per orally once daily for 30 days.
Receives: Drug: placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. brachial flow mediated dilatation (FMD)

    ultrasonographically measured flow mediated dilatation of brachial artery

    Measured: 30 days

  2. carotid pulse wave velocity (c-PWV)

    ultrasonographically measured pulse wave velocity of carotid artery

    Measured: 30 days

  3. β-stiffness coefficient

    ultrasonographically measured β-stiffness coefficient of carotid artery

    Measured: 30 days

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

    carotid-femoral pulse wave velocity measured by Sphygmocor

    Measured: 30 days

  5. reactive hyperemia index (RHI)

    reactive hyperemia index measured by an Endopat device

    Measured: 30 days

Secondary outcomes (5)

  1. brachial flow mediated dilatation (FMD)

    ultrasonographically measured flow mediated dilatation of brachial artery

    Measured: 10 weeks after termination of intervention

  2. carotid pulse wave velocity (c-PWV)

    ultrasonographically measured pulse wave velocity of carotid artery

    Measured: 10 weeks after termination of intervention

  3. β-stiffness coefficient

    ultrasonographically measured β-stiffness coefficient of carotid artery

    Measured: 10 weeks after termination of intervention

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

    carotid-femoral pulse wave velocity measured by Sphygmocor

    Measured: 10 weeks after termination of intervention

  5. reactive hyperemia index (RHI)

    reactive hyperemia index measured by an Endopat device

    Measured: 10 weeks after termination of intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Oct 2017
  2. Study startNov 2012
  3. Primary completionNov 2013
  4. Study completionNov 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
36 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03309618
Sponsor's protocol ID
AGE-MI
Status last verified
Oct 2017
First submitted
4 Oct 2017
Last updated
16 Oct 2017
Results posted
No
Individual data sharing
No

Publications

  • Neunteufl T, Heher S, Katzenschlager R, Wolfl G, Kostner K, Maurer G, Weidinger F. Late prognostic value of flow-mediated dilation in the brachial artery of patients with chest pain. Am J Cardiol. 2000 Jul 15;86(2):207-10. doi: 10.1016/s0002-9149(00)00857-2. No abstract available.

    PubMed 10913483

  • Bonetti PO, Lerman LO, Lerman A. Endothelial dysfunction: a marker of atherosclerotic risk. Arterioscler Thromb Vasc Biol. 2003 Feb 1;23(2):168-75. doi: 10.1161/01.atv.0000051384.43104.fc.

    PubMed 12588755

  • Vlachopoulos C, Aznaouridis K, Stefanadis C. Prediction of cardiovascular events and all-cause mortality with arterial stiffness: a systematic review and meta-analysis. J Am Coll Cardiol. 2010 Mar 30;55(13):1318-27. doi: 10.1016/j.jacc.2009.10.061.

    PubMed 20338492

  • Stefanadis C, Dernellis J, Tsiamis E, Stratos C, Diamantopoulos L, Michaelides A, Toutouzas P. Aortic stiffness as a risk factor for recurrent acute coronary events in patients with ischaemic heart disease. Eur Heart J. 2000 Mar;21(5):390-6. doi: 10.1053/euhj.1999.1756.

    PubMed 10666353

  • Orlova IA, Nuraliev EY, Yarovaya EB, Ageev FT. Prognostic value of changes in arterial stiffness in men with coronary artery disease. Vasc Health Risk Manag. 2010 Nov 4;6:1015-21. doi: 10.2147/VHRM.S13591.

    PubMed 21127698

  • Li Z, Iwai M, Wu L, Liu HW, Chen R, Jinno T, Suzuki J, Tsuda M, Gao XY, Okumura M, Cui TX, Horiuchi M. Fluvastatin enhances the inhibitory effects of a selective AT1 receptor blocker, valsartan, on atherosclerosis. Hypertension. 2004 Nov;44(5):758-63. doi: 10.1161/01.HYP.0000145179.44166.0f. Epub 2004 Sep 27.

    PubMed 15452025

  • Inaba Y, Chen JA, Bergmann SR. Prediction of future cardiovascular outcomes by flow-mediated vasodilatation of brachial artery: a meta-analysis. Int J Cardiovasc Imaging. 2010 Aug;26(6):631-40. doi: 10.1007/s10554-010-9616-1. Epub 2010 Mar 26.

    PubMed 20339920

  • 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.

    PubMed 28384560

  • Lunder M, Janic M, Jug B, Sabovic M. The effects of low-dose fluvastatin and valsartan combination on arterial function: a randomized clinical trial. Eur J Intern Med. 2012 Apr;23(3):261-6. doi: 10.1016/j.ejim.2011.11.011. Epub 2011 Dec 12.

    PubMed 22385885

  • Boncelj Svetek M, Erzen B, Kanc K, Sabovic M. Impaired endothelial function and arterial stiffness in patients with type 2 diabetes - The effect of a very low-dose combination of fluvastatin and valsartan. J Diabetes Complications. 2017 Mar;31(3):544-550. doi: 10.1016/j.jdiacomp.2016.12.002. Epub 2016 Dec 16.

    PubMed 28012835

  • Janic M, Lunder M, Cerkovnik P, Prosenc Zmrzljak U, Novakovic S, Sabovic M. Low-Dose Fluvastatin and Valsartan Rejuvenate the Arterial Wall Through Telomerase Activity Increase in Middle-Aged Men. Rejuvenation Res. 2016 Apr;19(2):115-9. doi: 10.1089/rej.2015.1722. Epub 2016 Jan 22.

    PubMed 26214555

Questions about this trial

What is this clinical trial studying?

A study testing low-dose combination of fluvastatin (10 mg) and valsartan (20 mg) (low-flu/val) in people with Myocardial Infarction, run by University Medical Centre Ljubljana at 1 site in Slovenia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Slovenia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

brachial flow mediated dilatation (FMD) (time frame: 30 days). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03309618, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2017.

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