NCT02403349

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
105

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started May 2012

Typical duration for phase_4

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2012

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

March 12, 2015

Completed
19 days until next milestone

First Posted

Study publicly available on registry

March 31, 2015

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
Last Updated

March 31, 2015

Status Verified

March 1, 2015

Enrollment Period

3 years

First QC Date

March 12, 2015

Last Update Submit

March 26, 2015

Conditions

Blood PressureIschemic Stroke

Outcome Measures

Primary Outcomes (1)

  • Central Blood pressure control

    12 weeks

Secondary Outcomes (6)

  • Blood pressure at the brachial artery

    12 weeks

  • Brachial-ankle pulse wave velocity (ba-PWV)

    12 weeks

  • Flow-mediated dilation (FMD)

    12 weeks

  • Pulsatile index (PI)

    12 weeks

  • Cerebral blood flow (CBF) volume

    12 weeks

  • +1 more secondary outcomes

Study Arms (3)

Fimasartan

EXPERIMENTAL

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

Drug: Fimasartan

Valsartan

ACTIVE COMPARATOR

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

Drug: Valsartan

Atenolol

ACTIVE COMPARATOR

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

Drug: Atenolol

Interventions

FimasartanDRUG
Also known as: kanarb
Fimasartan
ValsartanDRUG
Also known as: Diovan
Valsartan
AtenololDRUG
Also known as: tenormin
Atenolol

Eligibility Criteria

Age30 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (25)

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  • 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.

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  • 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.

    PMID: 15879332RESULT

  • 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.

    PMID: 21183747RESULT

  • 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.

    PMID: 14581662RESULT

  • 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.

    PMID: 21316752RESULT

  • 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.

    PMID: 19817870RESULT

  • 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.

    PMID: 17179034RESULT

  • 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.

    PMID: 20228403RESULT

  • 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.

    PMID: 18268136RESULT

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    PMID: 17485598RESULT

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    PMID: 11897754RESULT

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    PMID: 19850215RESULT

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    PMID: 16476843RESULT

  • 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.

    PMID: 16448896RESULT

  • 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.

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  • 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.

    PMID: 17510503RESULT

  • 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.

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    PMID: 19628800RESULT

  • 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.

    PMID: 20838053RESULT

  • 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.

    PMID: 21597296RESULT

MeSH Terms

Conditions

Ischemic Stroke

Interventions

fimasartanValsartanAtenolol

Condition Hierarchy (Ancestors)

StrokeCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

TetrazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsValineAmino Acids, Branched-ChainAmino AcidsAmino Acids, Peptides, and ProteinsAmino Acids, EssentialPhenoxypropanolaminesPropanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsPropanolsAmines

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

March 12, 2015

First Posted

March 31, 2015

Study Start

May 1, 2012

Primary Completion

May 1, 2015

Study Completion

September 1, 2015

Last Updated

March 31, 2015

Record last verified: 2015-03