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Blood PressurePhase 4FAVORNCT02403349

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

A Phase 4 study testing Fimasartan, Valsartan and Atenolol in people with Blood Pressure and Ischemic Stroke, run by Ajou University School of Medicine.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 30 years and older
Conditions the study is for
Blood Pressure, Ischemic Stroke
What is being tested?
Fimasartan, Valsartan and Atenolol
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
105 participants
Where
No sites listed yet
Study dates
May 2012to Sep 2015
Phase
Phase 4
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 30 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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)
Show all 11Show fewer
  • 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

About this study

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.

Being tested
Fimasartan, Valsartan, Atenolol
Medical subject headings
Ischemic Stroke

What participants receive

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

  • FimasartanDrug

    Also called kanarb

  • ValsartanDrug

    Also called Diovan

  • AtenololDrug

    Also called tenormin

Study groups in NCT02403349
Study groupRoleWhat they receive
FimasartanExperimentalfimasartan potassium 60mg, 1 tablet by mouth, every day Angiotensin ll receptor blocker
Receives: Drug: Fimasartan
ValsartanActive comparatorvalsartan 80mg, 1 tablet by mouth, every day angiotensin II receptor antagonists
Receives: Drug: Valsartan
AtenololActive comparatoratenolol 50mg, 1 tablet by mouth, every day beta-blocker
Receives: Drug: Atenolol

What is being measured

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

  1. Central Blood pressure control

    Measured: 12 weeks

Secondary outcomes (6)

  1. Blood pressure at the brachial artery

    Measured: 12 weeks

  2. 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.

    Measured: 12 weeks

  3. 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.

    Measured: 12 weeks

  4. 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).

    Measured: 12 weeks

  5. 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).

    Measured: 12 weeks

  6. Adverse Events

    Measured: 12 weeks

Timeline

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

  1. First posted31 Mar 2015 (estimated)
  2. Study startMay 2012
  3. Primary completionMay 2015 (estimated)
  4. Study completionSep 2015 (estimated)

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 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
105 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02403349
Sponsor's protocol ID
AJIRB-MED-CT4-12-049-HJM
Acronym
FAVOR
Status last verified
Mar 2015
First submitted
12 Mar 2015
Last updated
31 Mar 2015
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 14656957

  • 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.

    PubMed 12493255

  • 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.

    PubMed 17253471

  • 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.

    PubMed 10639539

  • 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.

    PubMed 11937179

  • 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.

    PubMed 17337887

  • 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.

    PubMed 15879332

  • 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.

    PubMed 21183747

  • 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.

    PubMed 14581662

  • 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.

    PubMed 21316752

  • 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.

    PubMed 19817870

  • 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.

    PubMed 17179034

  • 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.

    PubMed 20228403

  • 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.

    PubMed 18268136

  • 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.

    PubMed 17485598

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Fimasartan, Valsartan and Atenolol in people with Blood Pressure and Ischemic Stroke, run by Ajou University School of Medicine.

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 6 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 31 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

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

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

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?

Central Blood pressure control (time frame: 12 weeks). 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 NCT02403349, which also lists 25 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 31 Mar 2015; AzTrials last refreshed its copy on 7 Nov 2026.

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