Ignite Creation Date:
2025-12-25 @ 4:55 AM
Ignite Modification Date:
2026-03-12 @ 8:07 PM
Study NCT ID:
NCT03309618
Status:
COMPLETED
Last Update Posted:
2017-10-16
First Post:
2017-10-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Post- Myocardial Infarction Arterial Wall Improvement by Low-dose Fluvastatin and Valsartan
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009203', 'term': 'Myocardial Infarction'}], 'ancestors': [{'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D007238', 'term': 'Infarction'}, {'id': 'D007511', 'term': 'Ischemia'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009336', 'term': 'Necrosis'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068756', 'term': 'Valsartan'}], 'ancestors': [{'id': 'D013777', 'term': 'Tetrazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D014633', 'term': 'Valine'}, {'id': 'D000597', 'term': 'Amino Acids, Branched-Chain'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D000601', 'term': 'Amino Acids, Essential'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 36}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-10', 'completionDateStruct': {'date': '2014-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-10-12', 'studyFirstSubmitDate': '2017-10-04', 'studyFirstSubmitQcDate': '2017-10-09', 'lastUpdatePostDateStruct': {'date': '2017-10-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-10-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2013-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'brachial flow mediated dilatation (FMD)', 'timeFrame': '30 days', 'description': 'ultrasonographically measured flow mediated dilatation of brachial artery'}, {'measure': 'carotid pulse wave velocity (c-PWV)', 'timeFrame': '30 days', 'description': 'ultrasonographically measured pulse wave velocity of carotid artery'}, {'measure': 'β-stiffness coefficient', 'timeFrame': '30 days', 'description': 'ultrasonographically measured β-stiffness coefficient of carotid artery'}, {'measure': 'carotid-femoral pulse wave velocity (cf-PWV)', 'timeFrame': '30 days', 'description': 'carotid-femoral pulse wave velocity measured by Sphygmocor'}, {'measure': 'reactive hyperemia index (RHI)', 'timeFrame': '30 days', 'description': 'reactive hyperemia index measured by an Endopat device'}], 'secondaryOutcomes': [{'measure': 'brachial flow mediated dilatation (FMD)', 'timeFrame': '10 weeks after termination of intervention', 'description': 'ultrasonographically measured flow mediated dilatation of brachial artery'}, {'measure': 'carotid pulse wave velocity (c-PWV)', 'timeFrame': '10 weeks after termination of intervention', 'description': 'ultrasonographically measured pulse wave velocity of carotid artery'}, {'measure': 'β-stiffness coefficient', 'timeFrame': '10 weeks after termination of intervention', 'description': 'ultrasonographically measured β-stiffness coefficient of carotid artery'}, {'measure': 'carotid-femoral pulse wave velocity (cf-PWV)', 'timeFrame': '10 weeks after termination of intervention', 'description': 'carotid-femoral pulse wave velocity measured by Sphygmocor'}, {'measure': 'reactive hyperemia index (RHI)', 'timeFrame': '10 weeks after termination of intervention', 'description': 'reactive hyperemia index measured by an Endopat device'}]}, 'conditionsModule': {'keywords': ['myocardial infarction', 'arterial stiffness', 'pulse wave velocity', 'flow mediated dilatation', 'fluvastatin', 'valsartan'], 'conditions': ['Myocardial Infarction']}, 'referencesModule': {'references': [{'pmid': '10913483', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '12588755', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '20338492', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '10666353', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '21127698', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '15452025', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '20339920', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '28384560', 'type': 'BACKGROUND', '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.'}, {'pmid': '22385885', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '28012835', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '26214555', 'type': 'BACKGROUND', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '55 Years', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* history of MI in the last 0.5 to 5 years\n* males\n* aged under 55 years\n\nExclusion Criteria:\n\n* diabetes mellitus\n* manifest peripheral artery disease or carotid artery disease\n* acute infection\n* chronic diseases\n* present therapy with fluvastatin and/or valsartan.'}, 'identificationModule': {'nctId': 'NCT03309618', 'briefTitle': 'Post- Myocardial Infarction Arterial Wall Improvement by Low-dose Fluvastatin and Valsartan', 'organization': {'class': 'OTHER', 'fullName': 'University Medical Centre Ljubljana'}, 'officialTitle': 'Improving Arterial Wall Characteristics in Patients After Myocardial Infarction With a Very Low Dose of Fluvastatin and Valsartan: Proof-of-concept Study', 'orgStudyIdInfo': {'id': 'AGE-MI'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment group', '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.', 'interventionNames': ['Drug: low-dose combination of fluvastatin (10 mg) and valsartan (20 mg) (low-flu/val)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control group', 'description': '16 participants received placebo per orally once daily for 30 days.', 'interventionNames': ['Drug: placebo']}], 'interventions': [{'name': 'low-dose combination of fluvastatin (10 mg) and valsartan (20 mg) (low-flu/val)', 'type': 'DRUG', 'armGroupLabels': ['Treatment group']}, {'name': 'placebo', 'type': 'DRUG', 'armGroupLabels': ['Control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'SI-1000', 'city': 'Ljubljana', 'country': 'Slovenia', 'facility': 'Department of Vascular Diseases, University Medical Centre Ljubljana', 'geoPoint': {'lat': 46.05108, 'lon': 14.50513}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Medical Centre Ljubljana', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator, M.D.', 'investigatorFullName': 'Martina Turk Veselič', 'investigatorAffiliation': 'University Medical Centre Ljubljana'}}}}