search
Back to results

Comparison of Peripheral and Cerebral Arterial Flow in Acute Ischemic Stroke: Fimasartan vs. Valsartan vs. Atenolol (FAVOR)

Primary Purpose

Blood Pressure, Ischemic Stroke

Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Fimasartan
Valsartan
Atenolol
Sponsored by
Ajou University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Blood Pressure

Eligibility Criteria

30 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age ≥ 30 years old
  • Acute ischemic stroke patient who has corresponding DWI(diffusion- weighted imaging) lesion correlated with symptom
  • after 7days, but within 28days from stroke onset
  • Diagnosed with Hypertension
  • hypertensive patients who taking anti-hypertensive drugs or SBP≥140mmHg
  • Informed consent

Exclusion Criteria:

  • Patients with hemorrhagic Stroke
  • Patients with severe Stroke - over NIHss(National Institutes of Health stroke scale) 16
  • Uncontrolled hypertension (SBP ≥200mmHg)
  • Patients with history of allergic reaction to any angiotensin II antagonist
  • Liver disease(more than double to normal level, SGOT(serum glutamic-oxaloacetic transaminase ), SGPT(serum glutamic-pyruvic transaminase ), total bilirubin)
  • Renal disease(serum creatinine ≥2.0mg/dl)
  • Anemia(Hb < 8mg/dl)
  • Thrombocytopenia( < 10^3/ml)
  • Patients with secondary hypertension
  • Childbearing and breast-feeding women
  • Otherwise inappropriate patients depending on the investigator's decision

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Active Comparator

    Active Comparator

    Arm Label

    Fimasartan

    Valsartan

    Atenolol

    Arm Description

    fimasartan potassium 60mg, 1 tablet by mouth, every day Angiotensin ll receptor blocker

    valsartan 80mg, 1 tablet by mouth, every day angiotensin II receptor antagonists

    atenolol 50mg, 1 tablet by mouth, every day beta-blocker

    Outcomes

    Primary Outcome Measures

    Central Blood pressure control

    Secondary Outcome Measures

    Blood pressure at the brachial artery
    Brachial-ankle pulse wave velocity (ba-PWV)
    Ba-PWV is measured using ABI/PWV (VP-2000; Colin). This device has four cuffs that can be used to simultaneously measure blood pressure in both arms and both legs, and automatically calculate the ABI. It also records pulse waves with the sensors in the cuffs, computes the difference between transmission time in the arm and transmission time in the ankle, calculates the transmission distance from the right arm to each ankle according to body height, and thus computes the ba-PWV values from the transmission time and transmission distance.
    Flow-mediated dilation (FMD)
    FMD is measured as the brachial artery diameters at baseline and at maximum dilation after forearm ischemia for 5 minutes. FMD is calculated as the percentage of postischemic dilation.
    Pulsatile index (PI)
    We analyze the change of PIs in the middle cerebral artery at baseline and 90 Days on transcranial Doppler (TCD) Study in the same patient. The PI is automatically calculated on the TCD machine (PMD 150, Sphencer technologies, USA).
    Cerebral blood flow (CBF) volume
    CBF volume is measured by color-coded duplex sonography measuring total flow volumes of the internal carotid artery (ICAs) and vertebral artery (VAs).
    Adverse Events

    Full Information

    First Posted
    March 12, 2015
    Last Updated
    March 26, 2015
    Sponsor
    Ajou University School of Medicine
    Collaborators
    Boryung Pharmaceutical Co., Ltd
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT02403349
    Brief Title
    Comparison of Peripheral and Cerebral Arterial Flow in Acute Ischemic Stroke: Fimasartan vs. Valsartan vs. Atenolol
    Acronym
    FAVOR
    Official Title
    Comparison of Peripheral and Cerebral Arterial Flow in Acute Ischemic Stroke: Fimasartan vs. Valsartan vs. Atenolol
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2015
    Overall Recruitment Status
    Unknown status
    Study Start Date
    May 2012 (undefined)
    Primary Completion Date
    May 2015 (Anticipated)
    Study Completion Date
    September 2015 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Ajou University School of Medicine
    Collaborators
    Boryung Pharmaceutical Co., Ltd

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Confirm central blood pressure reduction effect of Fimasartan, Valsartan and Atenolol and compare correlation with the measured peripheral (central blood pressure, pulse wave velocity, and flow-mediated dilation) and cerebral blood flow factors (transcranial doppler findings, cerebral blood flow volume) in acute ischemic stroke patients with hypertension.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Blood Pressure, Ischemic Stroke

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    105 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Fimasartan
    Arm Type
    Experimental
    Arm Description
    fimasartan potassium 60mg, 1 tablet by mouth, every day Angiotensin ll receptor blocker
    Arm Title
    Valsartan
    Arm Type
    Active Comparator
    Arm Description
    valsartan 80mg, 1 tablet by mouth, every day angiotensin II receptor antagonists
    Arm Title
    Atenolol
    Arm Type
    Active Comparator
    Arm Description
    atenolol 50mg, 1 tablet by mouth, every day beta-blocker
    Intervention Type
    Drug
    Intervention Name(s)
    Fimasartan
    Other Intervention Name(s)
    kanarb
    Intervention Type
    Drug
    Intervention Name(s)
    Valsartan
    Other Intervention Name(s)
    Diovan
    Intervention Type
    Drug
    Intervention Name(s)
    Atenolol
    Other Intervention Name(s)
    tenormin
    Primary Outcome Measure Information:
    Title
    Central Blood pressure control
    Time Frame
    12 weeks
    Secondary Outcome Measure Information:
    Title
    Blood pressure at the brachial artery
    Time Frame
    12 weeks
    Title
    Brachial-ankle pulse wave velocity (ba-PWV)
    Description
    Ba-PWV is measured using ABI/PWV (VP-2000; Colin). This device has four cuffs that can be used to simultaneously measure blood pressure in both arms and both legs, and automatically calculate the ABI. It also records pulse waves with the sensors in the cuffs, computes the difference between transmission time in the arm and transmission time in the ankle, calculates the transmission distance from the right arm to each ankle according to body height, and thus computes the ba-PWV values from the transmission time and transmission distance.
    Time Frame
    12 weeks
    Title
    Flow-mediated dilation (FMD)
    Description
    FMD is measured as the brachial artery diameters at baseline and at maximum dilation after forearm ischemia for 5 minutes. FMD is calculated as the percentage of postischemic dilation.
    Time Frame
    12 weeks
    Title
    Pulsatile index (PI)
    Description
    We analyze the change of PIs in the middle cerebral artery at baseline and 90 Days on transcranial Doppler (TCD) Study in the same patient. The PI is automatically calculated on the TCD machine (PMD 150, Sphencer technologies, USA).
    Time Frame
    12 weeks
    Title
    Cerebral blood flow (CBF) volume
    Description
    CBF volume is measured by color-coded duplex sonography measuring total flow volumes of the internal carotid artery (ICAs) and vertebral artery (VAs).
    Time Frame
    12 weeks
    Title
    Adverse Events
    Time Frame
    12 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    30 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Age ≥ 30 years old Acute ischemic stroke patient who has corresponding DWI(diffusion- weighted imaging) lesion correlated with symptom after 7days, but within 28days from stroke onset Diagnosed with Hypertension hypertensive patients who taking anti-hypertensive drugs or SBP≥140mmHg Informed consent Exclusion Criteria: Patients with hemorrhagic Stroke Patients with severe Stroke - over NIHss(National Institutes of Health stroke scale) 16 Uncontrolled hypertension (SBP ≥200mmHg) Patients with history of allergic reaction to any angiotensin II antagonist Liver disease(more than double to normal level, SGOT(serum glutamic-oxaloacetic transaminase ), SGPT(serum glutamic-pyruvic transaminase ), total bilirubin) Renal disease(serum creatinine ≥2.0mg/dl) Anemia(Hb < 8mg/dl) Thrombocytopenia( < 10^3/ml) Patients with secondary hypertension Childbearing and breast-feeding women Otherwise inappropriate patients depending on the investigator's decision

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    14656957
    Citation
    Chobanian AV, Bakris GL, Black HR, Cushman WC, Green LA, Izzo JL Jr, Jones DW, Materson BJ, Oparil S, Wright JT Jr, Roccella EJ; Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure. National Heart, Lung, and Blood Institute; National High Blood Pressure Education Program Coordinating Committee. Seventh report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure. Hypertension. 2003 Dec;42(6):1206-52. doi: 10.1161/01.HYP.0000107251.49515.c2. Epub 2003 Dec 1.
    Results Reference
    result
    PubMed Identifier
    12493255
    Citation
    Lewington S, Clarke R, Qizilbash N, Peto R, Collins R; Prospective Studies Collaboration. Age-specific relevance of usual blood pressure to vascular mortality: a meta-analysis of individual data for one million adults in 61 prospective studies. Lancet. 2002 Dec 14;360(9349):1903-13. doi: 10.1016/s0140-6736(02)11911-8. Erratum In: Lancet. 2003 Mar 22;361(9362):1060.
    Results Reference
    result
    PubMed Identifier
    17253471
    Citation
    Wiysonge CS, Bradley H, Mayosi BM, Maroney R, Mbewu A, Opie LH, Volmink J. Beta-blockers for hypertension. Cochrane Database Syst Rev. 2007 Jan 24;(1):CD002003. doi: 10.1002/14651858.CD002003.pub2.
    Results Reference
    result
    PubMed Identifier
    10639539
    Citation
    Heart Outcomes Prevention Evaluation Study Investigators; Yusuf S, Sleight P, Pogue J, Bosch J, Davies R, Dagenais G. Effects of an angiotensin-converting-enzyme inhibitor, ramipril, on cardiovascular events in high-risk patients. N Engl J Med. 2000 Jan 20;342(3):145-53. doi: 10.1056/NEJM200001203420301. Erratum In: 2000 May 4;342(18):1376. N Engl J Med 2000 Mar 9;342(10):748.
    Results Reference
    result
    PubMed Identifier
    11937179
    Citation
    Lindholm LH, Ibsen H, Dahlof B, Devereux RB, Beevers G, de Faire U, Fyhrquist F, Julius S, Kjeldsen SE, Kristiansson K, Lederballe-Pedersen O, Nieminen MS, Omvik P, Oparil S, Wedel H, Aurup P, Edelman J, Snapinn S; LIFE Study Group. Cardiovascular morbidity and mortality in patients with diabetes in the Losartan Intervention For Endpoint reduction in hypertension study (LIFE): a randomised trial against atenolol. Lancet. 2002 Mar 23;359(9311):1004-10. doi: 10.1016/S0140-6736(02)08090-X.
    Results Reference
    result
    PubMed Identifier
    17337887
    Citation
    Diener HC, Sacco R, Yusuf S; Steering Committee; PRoFESS Study Group. Rationale, design and baseline data of a randomized, double-blind, controlled trial comparing two antithrombotic regimens (a fixed-dose combination of extended-release dipyridamole plus ASA with clopidogrel) and telmisartan versus placebo in patients with strokes: the Prevention Regimen for Effectively Avoiding Second Strokes Trial (PRoFESS). Cerebrovasc Dis. 2007;23(5-6):368-80. doi: 10.1159/000100105. Epub 2007 Feb 26. Erratum In: Cerebrovasc Dis. 2008;25(1-2):192.
    Results Reference
    result
    PubMed Identifier
    15879332
    Citation
    Schrader J, Luders S, Kulschewski A, Hammersen F, Plate K, Berger J, Zidek W, Dominiak P, Diener HC; MOSES Study Group. Morbidity and Mortality After Stroke, Eprosartan Compared with Nitrendipine for Secondary Prevention: principal results of a prospective randomized controlled study (MOSES). Stroke. 2005 Jun;36(6):1218-26. doi: 10.1161/01.STR.0000166048.35740.a9. Epub 2005 May 5.
    Results Reference
    result
    PubMed Identifier
    21183747
    Citation
    Geeganage C, Tracy M, England T, Sare G, Moulin T, Woimant F, Christensen H, De Deyn PP, Leys D, O'Neill D, Ringelstein EB, Bath PM; for TAIST Investigators. Relationship between baseline blood pressure parameters (including mean pressure, pulse pressure, and variability) and early outcome after stroke: data from the Tinzaparin in Acute Ischaemic Stroke Trial (TAIST). Stroke. 2011 Feb;42(2):491-3. doi: 10.1161/STROKEAHA.110.596163. Epub 2010 Dec 23.
    Results Reference
    result
    PubMed Identifier
    14581662
    Citation
    Oliveira-Filho J, Silva SC, Trabuco CC, Pedreira BB, Sousa EU, Bacellar A. Detrimental effect of blood pressure reduction in the first 24 hours of acute stroke onset. Neurology. 2003 Oct 28;61(8):1047-51. doi: 10.1212/01.wnl.0000092498.75010.57.
    Results Reference
    result
    PubMed Identifier
    21316752
    Citation
    Sandset EC, Bath PM, Boysen G, Jatuzis D, Korv J, Luders S, Murray GD, Richter PS, Roine RO, Terent A, Thijs V, Berge E; SCAST Study Group. The angiotensin-receptor blocker candesartan for treatment of acute stroke (SCAST): a randomised, placebo-controlled, double-blind trial. Lancet. 2011 Feb 26;377(9767):741-50. doi: 10.1016/S0140-6736(11)60104-9.
    Results Reference
    result
    PubMed Identifier
    19817870
    Citation
    Steckelings UM, Rompe F, Kaschina E, Unger T. The evolving story of the RAAS in hypertension, diabetes and CV disease: moving from macrovascular to microvascular targets. Fundam Clin Pharmacol. 2009 Dec;23(6):693-703. doi: 10.1111/j.1472-8206.2009.00780.x. Epub 2009 Oct 9.
    Results Reference
    result
    PubMed Identifier
    17179034
    Citation
    Dzau VJ, Antman EM, Black HR, Hayes DL, Manson JE, Plutzky J, Popma JJ, Stevenson W. The cardiovascular disease continuum validated: clinical evidence of improved patient outcomes: part I: Pathophysiology and clinical trial evidence (risk factors through stable coronary artery disease). Circulation. 2006 Dec 19;114(25):2850-70. doi: 10.1161/CIRCULATIONAHA.106.655688. No abstract available.
    Results Reference
    result
    PubMed Identifier
    20228403
    Citation
    NAVIGATOR Study Group; McMurray JJ, Holman RR, Haffner SM, Bethel MA, Holzhauer B, Hua TA, Belenkov Y, Boolell M, Buse JB, Buckley BM, Chacra AR, Chiang FT, Charbonnel B, Chow CC, Davies MJ, Deedwania P, Diem P, Einhorn D, Fonseca V, Fulcher GR, Gaciong Z, Gaztambide S, Giles T, Horton E, Ilkova H, Jenssen T, Kahn SE, Krum H, Laakso M, Leiter LA, Levitt NS, Mareev V, Martinez F, Masson C, Mazzone T, Meaney E, Nesto R, Pan C, Prager R, Raptis SA, Rutten GE, Sandstroem H, Schaper F, Scheen A, Schmitz O, Sinay I, Soska V, Stender S, Tamas G, Tognoni G, Tuomilehto J, Villamil AS, Vozar J, Califf RM. Effect of valsartan on the incidence of diabetes and cardiovascular events. N Engl J Med. 2010 Apr 22;362(16):1477-90. doi: 10.1056/NEJMoa1001121. Epub 2010 Mar 14. Erratum In: N Engl J Med. 2010 May 6;362(18):1748.
    Results Reference
    result
    PubMed Identifier
    18268136
    Citation
    Jankowski P, Kawecka-Jaszcz K, Czarnecka D, Brzozowska-Kiszka M, Styczkiewicz K, Loster M, Kloch-Badelek M, Wilinski J, Curylo AM, Dudek D; Aortic Blood Pressure and Survival Study Group. Pulsatile but not steady component of blood pressure predicts cardiovascular events in coronary patients. Hypertension. 2008 Apr;51(4):848-55. doi: 10.1161/HYPERTENSIONAHA.107.101725. Epub 2008 Feb 11.
    Results Reference
    result
    PubMed Identifier
    17485598
    Citation
    Roman MJ, Devereux RB, Kizer JR, Lee ET, Galloway JM, Ali T, Umans JG, Howard BV. Central pressure more strongly relates to vascular disease and outcome than does brachial pressure: the Strong Heart Study. Hypertension. 2007 Jul;50(1):197-203. doi: 10.1161/HYPERTENSIONAHA.107.089078. Epub 2007 May 7.
    Results Reference
    result
    PubMed Identifier
    11897754
    Citation
    Safar ME, Blacher J, Pannier B, Guerin AP, Marchais SJ, Guyonvarc'h PM, London GM. Central pulse pressure and mortality in end-stage renal disease. Hypertension. 2002 Mar 1;39(3):735-8. doi: 10.1161/hy0202.098325.
    Results Reference
    result
    PubMed Identifier
    19850215
    Citation
    Roman MJ, Devereux RB, Kizer JR, Okin PM, Lee ET, Wang W, Umans JG, Calhoun D, Howard BV. High central pulse pressure is independently associated with adverse cardiovascular outcome the strong heart study. J Am Coll Cardiol. 2009 Oct 27;54(18):1730-4. doi: 10.1016/j.jacc.2009.05.070.
    Results Reference
    result
    PubMed Identifier
    16476843
    Citation
    Williams B, Lacy PS, Thom SM, Cruickshank K, Stanton A, Collier D, Hughes AD, Thurston H, O'Rourke M; CAFE Investigators; Anglo-Scandinavian Cardiac Outcomes Trial Investigators; CAFE Steering Committee and Writing Committee. Differential impact of blood pressure-lowering drugs on central aortic pressure and clinical outcomes: principal results of the Conduit Artery Function Evaluation (CAFE) study. Circulation. 2006 Mar 7;113(9):1213-25. doi: 10.1161/CIRCULATIONAHA.105.595496. Epub 2006 Feb 13.
    Results Reference
    result
    PubMed Identifier
    16448896
    Citation
    Dhakam Z, McEniery CM, Yasmin, Cockcroft JR, Brown MJ, Wilkinson IB. Atenolol and eprosartan: differential effects on central blood pressure and aortic pulse wave velocity. Am J Hypertens. 2006 Feb;19(2):214-9. doi: 10.1016/j.amjhyper.2005.08.007.
    Results Reference
    result
    PubMed Identifier
    9220209
    Citation
    Neutel J, Weber M, Pool J, Smith D, Fitzsimmons S, Chiang YT, Gatlin M. Valsartan, a new angiotensin II antagonist: antihypertensive effects over 24 hours. Clin Ther. 1997 May-Jun;19(3):447-58; discussion 367-8. doi: 10.1016/s0149-2918(97)80129-4.
    Results Reference
    result
    PubMed Identifier
    17510503
    Citation
    Takazawa K, Kobayashi H, Shindo N, Tanaka N, Yamashina A. Relationship between radial and central arterial pulse wave and evaluation of central aortic pressure using the radial arterial pulse wave. Hypertens Res. 2007 Mar;30(3):219-28. doi: 10.1291/hypres.30.219.
    Results Reference
    result
    PubMed Identifier
    12135313
    Citation
    Yamashina A, Tomiyama H, Takeda K, Tsuda H, Arai T, Hirose K, Koji Y, Hori S, Yamamoto Y. Validity, reproducibility, and clinical significance of noninvasive brachial-ankle pulse wave velocity measurement. Hypertens Res. 2002 May;25(3):359-64. doi: 10.1291/hypres.25.359.
    Results Reference
    result
    PubMed Identifier
    19628800
    Citation
    Lim MH, Cho YI, Jeong SK. Homocysteine and pulsatility index of cerebral arteries. Stroke. 2009 Oct;40(10):3216-20. doi: 10.1161/STROKEAHA.109.558403. Epub 2009 Jul 23.
    Results Reference
    result
    PubMed Identifier
    20838053
    Citation
    Kim DH, Choi JH, Moon JS, Kim HJ, Cha JK. Association between the severity of cerebral small vessel disease, pulsatility of cerebral arteries, and brachial ankle pulse wave velocity in patients with lacunar infarction. Eur Neurol. 2010;64(4):247-52. doi: 10.1159/000319923. Epub 2010 Sep 11.
    Results Reference
    result
    PubMed Identifier
    21597296
    Citation
    Hong JM, Lee JS, Shin DH, Yong SW. Hemodynamic impact of fetal-variant Willisian circle on cerebral circulation: a duplex ultrasonography study. Eur Neurol. 2011;65(6):340-5. doi: 10.1159/000327213. Epub 2011 May 19.
    Results Reference
    result

    Learn more about this trial

    Comparison of Peripheral and Cerebral Arterial Flow in Acute Ischemic Stroke: Fimasartan vs. Valsartan vs. Atenolol

    We'll reach out to this number within 24 hrs